Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+

Our reference: MAT 6255 P-authorquery-v9 AUTHOR QUERY FORM Journal: MAT Please e-mail or fax your responses and any corrections to: E-mail: [email protected] Article Number: 6255 Fax: +353 6170 9272 Dear Author, Please check your proof carefully and mark all corrections at the appropriate place in the proof (e.g., by using on-screen annotation in the PDF file) or compile them in a separate list. Note: if you opt to annotate the file with software other than Adobe Reader then please also highlight the appropriate place in the PDF file. To ensure fast publication of your paper please return your corrections within 48 hours. For correction or revision of any artwork, please consult http://www.elsevier.com/artworkinstructions. Any queries or remarks that have arisen during the processing of your manuscript are listed below and highlighted by flags in the proof. Click on the ‘Q’ link to go to the location in the proof. Location in Query / Remark: click on the Q link to go article Please insert your reply or correction at the corresponding line in the proof Q1 Please confirm that given names and surnames have been identified correctly. Q2 Please check all author names and affiliations. Q3 Please supply highlights consisting a short collection of 3–5 bullet points, not more than 125 characters that convey the core finding of the article. Q5 Please check that the (a) Contributors; (b) Competing Interest and (c) Funding information appears at the end of your article and is correct. Thank you. Q6 Please check that the (a) Contributors; (b) Competing Interest and (c) Funding information appears at the end of your article and is correct. Thank you. Q7 Please check the author’s name for correctness. Q8 Please provide the volume number for the bibliography in Ref. [5]. Please check this box or indicate your approval if you have no corrections to make to the PDF file Thank you for your assistance. MAT 6255 1 ARTICLE IN PRESS G Model Maturitas xxx (2014) xxx–xxx Contents lists available at ScienceDirect Maturitas jou rn al hom epage: www.elsevier.com/locate/maturitas Highlights Maturitas xxx (2014) xxx–xxx Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+ Francisco Álvarez-Barbosa, Jesús del Pozo-Cruz∗, Borja del Pozo-Cruz, Rosa M. Alfonso-Rosa, Michael E. Rogers, Yanxin Zhang •WBV-based intervention in a nursing home setting is effective in reducing fall risk factors. •WBV-based intervention is effective to improve quality of life in nursing home residents aged 80+.. Q3 Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 Maturitas xxx (2014) xxx–xxx Contents lists available at ScienceDirect Maturitas journal homepage: www.elsevier.com/locate/maturitas Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+ 1 2 3 Francisco Álvarez-Barbosaa,Jesús del Pozo-Cruza,∗,Borja del Pozo-Cruzb, Q1 Rosa M. Alfonso-Rosaa,Michael E. Rogersc,Yanxin Zhangb 4 5 aDepartment of Physical Education and Sports, University of Seville, Seville, Spain6 bDepartment of Sport and Exercise Science, University of Auckland, Auckland, New Zealand7 cDepartment of Human Performance Studies, Wichita State University, Wichita, KS, USA Q2 8 9 article info10 11 Article history:12 Received 10 August 201413 Received in revised form 9 September 2014 14 Accepted 22 September 2014 15 Available online xxx16 17 Keywords:18 Whole-body vibration19 Nursing home20 Aged 21 Quality of life22 abstract Objective: To test the feasibility and effectiveness of whole-body vibration (WBV) therapy on fall risk, functional dependence and health-related quality of life in nursing home residents aged 80+ years. Design: Twenty-nine 80–95 years old volunteers, nursing home residents were randomized to an eightweek WBV intervention group) (n=15) or control group (n=14). Functional mobility was assessed using the timed up and go (TUG) test. Lower limb performance was evaluated using the 30-s Chair Sit to Stand (30-s CSTS) test. Postural stability was measured using a force platform. The Barthel Index was used to assess functional dependence and the EuroQol (EQ-5D) was used to evaluate Health-Related Quality of Life. All outcome measures were assessed at baseline and at a follow-up after 8 weeks. Results: At the 8-week follow up, TUG test (p<0.001), 30-s CSTS number of times (p=0.006), EQ5Dmobility (p<0.001), EQ-5DVAS (p<0.014), EQ-5Dutility (p<0.001) and Barthel index (p=0.003) improved in the WBV intervention group when compared to the control group. Conclusions: An 8-week WBV-based intervention in a nursing home setting is effective in reducing fall risk factors and quality of life in nursing home residents aged 80+. © 2014 Published by Elsevier Ireland Ltd. 23 1. Introduction24 Falls are a major public health problem worldwide. Most inci-25 dents of falling are observed in older adults. At least 30% of people 26 over the age of 65 experiences a fall each year, and this percent-27 age increases up to 50% for those over 80 years [1]. Thus, falls are28 the leading cause of mortality [2] and morbidity [3] in older adults29 and account for extensive health care and social costs [4]. The inci-30 dence is about three times higher in institutionalized older adults31 comparedto independently-livingolder adults[5]. Moreover,inde32 pendence in activities of daily living are compromised in fallers 33 [6]. Therefore, health-related quality of life is often reduced in this34 population group [4].35 It has been well established that balance, postural control36 and mobility function decline with aging [7]. Also, muscle weak-37 ness and reduced strength [8] (identified as major modifiable risk38 ∗Corresponding author. Tel.: +0034 955420475. E-mail address: [email protected] (J. del Pozo-Cruz). factors for falls [9]) are part of the aging process. Moreover, older 39 adults living in a nursing home often have reduced mobility and 40 poor balance when compared with their peers living in the com41 munity [10]. Hence, feasible and effective interventions to modify 42 these fall-related risk factors are warranted among the older adult 43 population. Within this context, exercise is one of the most com44 mon strategies for fall prevention [11], even for those living in 45 nursing homes [5].46 There is also strong evidence for the effectiveness of strength 47 and balance exercise intervention programs for fall risk reduc48 tion [12,13], even for older adults living in nursing homes [5,14].49 However, an appropriate the appropriate combination of vibration 50 frequency and amplitude (dose) is necessary for successful fall risk 51 reduction [15]. Therefore, it has been stated that high-dose exer52 cise programs produce more significant results than a lower-dose 53 strategies [16]. Such programs seem to be feasible among indi54 viduals over 80 years of age [17], but frailer individuals, such as 55 nursing home residents, have difficulty performing such programs 56 because of the fatigue [17] or even fear of falling [14]. Thus, other 57 alternatives need to be evaluated with these individuals. 58 http://dx.doi.org/10.1016/j.maturitas.2014.09.010 0378-5122/© 2014 Published by Elsevier Ireland Ltd. Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 2F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx Table 1 Description of the training protocol. Weeks Sessions/wk Warm up Number of WBV exercises Number of WBV repetitions Frequency (Hz)/amplitude (mm) Rest period (s) WBV total repetitions WBV total session duration (min) 1–2 3 3/30s/30 s 6 6 30/4 45 48 12.3 3–4 3 3/30s/30 s 6 8 30/4 45 64 13.9 5–6 3 3/30s/30 s 6 10 35/4 45 80 15.5 7–8 3 3/30s/30 s 6 12 35/4 45 96 17.1 Whole-body vibration (WBV) training has become increasingly59 popular over the past several years as an effective alternative to60 conventional exercise programs. WBV training minimizes the need61 for conscious exertion and stress on the musculoskeletal, respi-62 ratory and cardiovascular systems in comparison with traditional63 exercises [18]. In addition, over a short period of time, it can be use-64 ful for improving postural control among older adults [19], thereby 65 reducing risk of falls in this population [20]. Subsequently, WBV 66 training can be applied in frailer persons as well as in those that67 report a previous sedentary status [20]. Therefore, WBV training68 has been shown to be feasible among older adults living in nursing 69 homes [21]. The same study demonstrated that dynamic exercises70 upon WBV have been shown to be more effective on some func-71 tional outcomes than static exercise. 72 Unfortunately, few studies have been conducted to test the use73 fulness of WBV training to reduce the risk of falling (or related74 factors) among nursing home residents and those that have been75 conductedhave yieldedinconsistent results[21–25]. Thefeasibility 76 and effectiveness of WBV for this purpose have rarely been inves-77 tigated among those over 80 years [22,24,25]. Moreover, only one78 of these studies assessed health-related quality of life [22] and, to 79 our knowledge, none of these studies have assessed the effects of 80 this type of therapy on either functional dependence or in lower81 limb muscle performance (including power) among this popula-82 tion. Therefore, the aim of this study was to determine if 8-weeks 83 of a dynamic WBV exercise program is feasible and effective for84 nursing home residents aged 80+ years and whether it offers any85 additional benefits to the usual nursing home care for fall-related 86 risk factors, health-related quality of life and functional depend87 ence among this clinical population.88 2. Materials and Methods89 2.1. Participants and study design90 A randomized controlled trial (ACTRN12613000189729) was91 conducted. The study was approved by the research ethics com-92 mittee of the University and conducted in accordance with the93 Declaration of Helsinki, as revised in Edinburgh, 2008. All par94 ticipants signed an informed consent form prior to participation 95 in the study. Participants in the study were recruited via health96 care staff from a nursing home facility. Residents were eligible97 for the study if they were at least 80 years old and were institu-98 tionalized in the nursing home where the study was performed.99 Potential participants were excluded if they had a pacemaker, knee100 or hip prosthesis, acute thrombosis or its high risk, acute muscu101 loskeletal inflammation, hernia, cardiac or other systemic disease 102 not well balanced with medical treatment, diabetic neuropathy, or103 severe vertigo. Ultimately, the medical staff from the nursing home104 checked the inclusion/exclusion criteria and granted the partici-105 pant’s enrollment in the program. Out of 60 eligible participants,106 35 showed initial interest in the study. However, only 29 fulfilled107 the inclusion/exclusion criteria and were allocated to one of the108 two study groups using a computer generated random allocation109 data processing program and a 1:1 ratio (intervention: control).110 Randomization was undertaken by a member of the research team 111 not directly involved in the recruitment or assessment of patients. 112 2.2. Experimental protocol 113 Participants in both the intervention and control groups had 114 access to the usual nursing home care available in public nursing 115 homes in the south of Spain (i.e., physiotherapy including 1h/week 116 oftherapeutic massageandheat therapyand 4hperweekofmobil117 ity and stretching exercise, occupational therapy—mainly designed 118 to train the memory, and nursing care). Participants in the control 119 group were further asked to not change their lifestyle. Participants 120 in the intervention group participated in an 8-week WBV-based 121 program consisting of three sessions per week with at least one 122 day between sessions. Description of the WBV intervention is pro123 vided in Table 1. Each exercise session was performed on a vertical 124 platform (YV20RS 700, BH, Spain) with a frequency of 30Hz for 125 the first month and 35Hz for the last month. Peak-to-peak dis126 placement of 4mm was maintained during the entire program. For 127 warm-up, participants adopted an isometric squat position flex128 ing the knees about 80◦for 30s. This exercise was repeated three 129 times. After that, participants were asked to perform six exercises 130 (step up and down, lunge, squat, calf raises, left and right pivot in a 131 front and lateral positions) with slow movements at a rate of 3s for 132 both concentric and eccentric phases. The repetitions in each exer133 cise were gradually increased every two weeks starting from 6 and 134 reaching 12 repetitions with a rest period of 45s for the entire pro135 gram. All participants in the intervention group received a training 136 session on the exercise program consisting of an explanation and 137 trial of the different exercises which comprised the training proto138 col. Each training session was supervised by one of the researchers 139 of the study and the physiotherapist of the nursing home. 140 2.3. Outcome measures 141 The outcomes measures were assessed before the randomiza142 tion and after the end of 8-week WBV intervention. All outcome 143 measures were performed in the nursing home. 144 Socio-demographic variables (i.e., age and gender) as well as 145 clinical predictor variables (i.e., years since home nursing care 146 and number of daily drugs) were recorded. Weight, height, and 147 waist and hip circumference were measured to calculate body148 massindex(BMI;kg/m2)andwaisttohipratio.Body-fatpercentage 149 was also estimated using an impedance analyzer (Omron BF150 306, Omron Healthcare Europe BV, Hoofddorp, The Netherlands) 151 according to the manufacturer’s instructions. 152 Functional mobility was assessed using the Time Up and Go 153 (TUG) test [26]. The score of this test has been previously used as 154 an important outcome among nursing home residents [22,27], and 155 even has been proposed as an indicator of fall risk in community156 dwelling older adults [28]. Participants had to stand up from a 157 standard chair, walk 2.44 meters to and around a cone, and then 158 return to the chair in the shortest possible time. The best time of 159 two trials (1-min rest period between each trial) was recorded. 160 Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx 3 This test was assessed at baseline and at the 2, 4, 6 and 8-week161 follow-up.162 Muscle performance was assessed using the 30-s Chair Sit to163 Stand (30-s CSTS) test [29]. This test has been previously used164 for nursing home residents [30]. Participants were instructed to165 perform the task which started and finished in a seated position.166 Participants were allowed a practice trial before the beginning of167 the test. The number of times within 30s that the participant could168 raise to a full stand from a seated position as fast as possible, with169 their back straight and feet flat on the floor without pushing off170 using their arms, was counted. The maximum speed of each rep-171 etition as well as the average speed was recorded with a Linear172 Encoder (Model TF-100, T-Force System Ergotech, Murcia, Spain)173 and the peak force was recorded using a Kistler force platform, type174 9281A (Kistler Instruments AG, Winterthur, Switzerland). The peak175 power during the test could then be calculated.176 Postural stability was measured using a Kistler force platform,177 type 9281A (Kistler Instruments AG, Winterthur, Switzerland) by178 recording the anterior–posterior (AP) and medial–lateral (ML) cen-179 ter of pressure (COP) excursions while in a quite standing posture.180 Sway ellipse area (cm2)was calculated 3 times each with increas-181 ing postural difficulty: (i) standing on the force platform with the182 eyes open, (ii) standing on the force platform with the eyes open183 (cognitive task) and (iii) standing on the force platform with the184 eyes closed. For each condition, three trials were performed. Each185 trial lasted for 30s and was followed by a rest period of 1min.In186 this case, only the final 20s were analyzed [31]. The cognitive task187 was counting backwards as fast and as accurately as possible by 3s188 whilst performing the standing task, beginning with a randomly189 selected number from a range of 100–200. Data were sampled at190 1000Hz and transformed to obtain COP values. 191 The Barthel Index (BI) of ADL [32] was used to measure per-192 formance in activities of daily living (ADL) of the participants. The193 Barthel Index of ADL is comprised of 10 items (bathing, grooming,194 feeding, dressing, bowels, bladder, toilet uses, stairs, transfer and195 mobility) that evaluate a person’s ability to perform activities of196 dailyliving.Total scoreswerecalculated bysummingtheindividual197 itemscores. Scoreswereweighted andrangedfrom0(dependence)198 to 100 (independence). For analysis purposes, those participants 199 scoring 100 were considered to be independent. 200 The EuroQol-5D (EQ-5D) [33] was used to assess health-201 related quality of life (HRQoL). The EQ-5D includes five dimensions202 (mobility, personal care, usual activities, pain/discomfort and anxi-203 ety/depression), each of which has three levels (no problems, some204 problems, or extreme problems/unable to) with answers ranging205 from 1 to 3. For analysis purposes, these dimensions were grouped 206 into problems and no problems. The juxtaposition of the levels207 for these five dimensions correlates to a five-digit number, which208 reflect 243 possible health status values. These health status values209 can be converted to a health functional index or a ‘utility’, using210 time-trade off values (EuroQol utility: 1=full functional quality of211 life, 0=death). The EQ-5D-3L also includes a vertical 20-cm Visual212 AnalogueScale(VAS)whichisusedbyparticipantstoratetheirown 213 health between 0 (worst imaginable health state) and 100 (best214 imaginable health state), thereby providing an overall numerical215 estimate of their HRQoL [34].216 2.4. Statistical analysis217 Intent to treat and per-protocol analyses were performed using218 SPSS version 17.0 (SPSS Inc., Chicago, IL, USA). The significance 219 level was set at p<0.05 for all analyses. The distribution of 220 the data was examined using the Shapiro Wilk test. After non-221 normal distribution of the data was confirmed, between-group222 comparisons at baseline were performed using Mann–Whitney 223 Utest for continuous variables or chi square analysis and224 between-groups comparisons after treatment were performed 225 using Mann–Whitney Utest or chi square analysis. Wilcoxon test 226 was used to assess the intra-group pre (baseline) to post (8-week 227 follow up) differences of the different outcomes of the study. Effect 228 sizes and probability of superiority were calculated and interpreted 229 according to previously published guidelines [35]. Friedman test 230 was used to compare the TUG test score and 30-s CSTS across the 231 8-week treatment in the intervention group and Wilcoxon test 232 was used to assess the differences between the different follow-up 233 points in the in the same group. 234 3. Results 235 Twenty-nine nursing home residents were finally randomized 236 into one of the two groups (Fig. 1). None of the participants in the 237 intervention group reported any adverse health effects during the 238 treatment.In theintervention group,73% (11out of15) ofall partic239 ipants completed at least 80% of the sessions offered in the program 240 and were included in the per protocol analysis. In the control group, 241 78% were assessed at baseline and during an 8-week follow-up and 242 werealsoincludedintheperprotocolanalysis.Intent-to-treatanal243 ysis was performed with the complete randomized sample. When 244 follow-up data were not available, the last value carried forward 245 method (i.e., take into account the last observation of the analysis) 246 was used to impute for the missed data. In the intervention group, 247 25% of follow-up data were imputed. In the rest of the cases, the 248 real observation was used as data. In the control group, 100% (3 out 249 of 3) of follow-up data were imputed. Participants in the interven250 tion group reported no adverse health events during the program 251 period. 252 The baseline characteristics of the study participants were 253 compared (Table 2). No statistically significant differences were 254 observed between participants in the two groups of the study. 255 Intent to treat analysis depicted similar results. 256 Mann–Whitney Utest depicted a statistically significant effect 257 of the treatment (i.e., WBV vs. usual care) at 8-week follow-up 258 on several lower limb performance outcomes assessed including 259 mobility [TUG test (p=<0.001)] and 30-s CSTS number of times 260 (p=0.006) (Table 3). We also detected a pre to post improvement 261 (i.e., greater scores) in the intervention group regarding the 30-s 262 CSTS peak power (Table 3). However, we did not detect any differ263 ences for any of the postural stability outcome measures assessed 264 (p>0.05). HRQoL [EQ-5Dmobility (p<0.001), EQ-5Dutility (p<0.001) 265 and EQ-5DVAS (p=0.014) and performance in ADL [Barthel index 266 (p=0.003) and the number of independent participants (p<0.001)] 267 improved (increased) in the intervention group as compared to the 268 control group (Table 4). Intent to treat analysis depicted similar 269 results. 270 TUG test scores improved (decreased) across the five follow-up 271 assessments (p=0.001). However, only statistical significant differ272 ences were detected between the scores at baseline and 4 weeks 273 (p=0.018), 6 weeks (p=0.021) and 8 weeks (p=0.010); between 274 2 weeks and 8 weeks (p=0.013); between 4 weeks and 8 weeks 275 (p=0.017) and between 6 weeks and 8 weeks (p=0.012) (Fig. 2). 276 Similarly, the 30-s CSTS number of times improved (increased) 277 acrossthefivefollow-upassessments(p<0.001).Inthiscase,statis278 tical significant differences were only detected between the scores 279 at baseline and 2 weeks (p=0.005), 4 weeks (p=0.003), 6 weeks 280 (p=0.005) and 8 weeks (p=0.007) (Fig. 2). Intent to treat analysis 281 depicted similar results. 282 4. Discussion 283 Falls are one of the leading causes of mortality [2] and mor284 bidity [3] among institutionalized older adults. In this study, we 285 Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 4F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx Fig. 1. Flow diagram of the participants in the study. Table 2 Demographic and clinical characteristics of study participants. Variables Per protocol analysis Intent to treat analysis Control group (n=11) WBV group (n=11) pControl group (n= 15) WBV group (n=14) p Socio-economic variables Age (years) 85.5 (6.7) 84.0 (3.0) 0.595a86.0 (7.5) 84.0 (3.0) 0.523a Gender (% females) 81.8 72.7 0.611b85.7 80.0 0.684b Body composition BMI (kg/m2) 29.2 (7.2) 26.0 (3.4) 0.056a28.5 (7.7) 26.8 (3.4) 0.169a WHR 0.89 (0.1) 0.91 (0.1) 0.974a0.90 (0.1) 0.90 (0.09) 0.861a Body fat (%) 42.8 (14.0) 40.6 (11.8) 0.725a42.7 (12.3) 43.9 (11.25) 0.520a Clinical variables Years institutionalizing 4.2 (6.8) 2.0 (3.0) 0.104a3.2 (5.6) 3.0 (2.6) 0.518a Number of daily drugs 8.0 (6.0) 5.0 (3.0) 0.113a7.5 (4.5) 5.0 (4.0) 0.148a Values are median (IQR) unless otherwise indicated; BMI: Body Mass Index; WHR: waist to hip ratio; p:pvalue from Mann–Whitney Uaor x2test b. Fig. 2. Median changes (IQR) in 30-s Chair Sit to Stand test score (left) and Time Up and Go test score (right) over the 8-wk treatment in the participants that followed the whole body vibration intervention. *Denotes statistical significant differences. Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx 5 Table 3 Lower limb performance outcomes. Outcome measures Per protocol analysis Baseline pPost-intervention pEffect size PS Control group (n=11) Intervention group (n=11) Control group (n=11) Intervention group (n=11) Time “Up and Go” Test (s) 14.25 (6.25) 11.00 (4.30) 0.231 15.70 (6.08) 9.70 (3.40)*<0.001 0.766 96 30-s CSTS (number of times) 7.00 (2.00) 7.00 (3.00) 0.920 7.00 (3.00) 11.00 (2.00)*<0.001 0.776 96 30-s CSTS Vmax (m/s) 0.46 (0.26) 0.54 (0.35) 0.341 0.49 (0.20) .056 (0.17) 0.082 0.371 71 30-s CSTS Vmed (m/s) 0.41 (0.23) 0.48 (0.31) 0.412 0.41 (0.16) 0.43 (0.22) 0.375 0.189 61 30-s CSTS strength (N) 787.93 (321.27) 644.24 (185.16) 0.491 802.02 (209.82) 750.38 (278.69) 0.450 0.161 61 30-s CSTS power (W) 399.48 (257.77) 373.29 (284.14) 0.922 414.01 (205.21) 419.55 (260.16)* 0.412 0.175 61 Area (cm2): opened eyes 2.43 (0.90) 1.39 (2.88) 0.200 2.35 (3.56) 1.83 (2.15) 0.178 0.287 66 Area (cm2): closed eyes 3.53 (2.89) 1.71 (2.99) 0.250 3.52 (3.62) 1.89 (4.03) 0.309 0.217 61 Area (cm2): cognitive interference 2.24 (1.91) 1.76 (6.01) 0.622 1.98 (1.72) 2.39 (0.99) 0.308 0.217 61 Intent to treat analysis Baseline PPost-intervention pEffect size PS Control group (n=15) Intervention group (n=14) Control group (n=15) Intervention group (n=14) 14.15 (7.67) 11.40 (4.90) 0.329 15.70 (6.27) 9.90 (4.80)*0.002 0.575 84 7.00 (3.00) 7.00 (4.00) 0.642 7.00 (3.00) 10.00 (2.00)*0.006 0.515 80 0.46 (0.21) 0.49 (0.26) 0.485 0.46 (0.18) 0.54 (0.26) 0.198 0.239 64 0.38 (0.19) 0.39 (0.28) 0.383 0.35 (0.16) 0.39 (0.27) 0.407 0.152 58 683.60 (580.96) 734.96 (185.16) 0.760 770.26 (485.88) 750.38 (266.31) 1.000 0.02 0 297.18 (285.46) 344.15 (259.71) 0.600 304.00 (256.55) 346.82 (279.40)*0.159 0.170 61 2.43 (1.50) 1.39 (4.66) 0.222 2.45 (3.85) 1.83 (2.13) 0.206 0.235 64 3.64 (4.87) 2.37 (2.84) 0.206 3.88 (7.18) 2.28 (4.36) 0.315 0.186 27 2.73 (2.89) 1.77 (4.44) 0.485 2.00 (3.17) 2.39 (1.52) 0.694 0.073 53 Values are median (IQR); Control group: group that had access to usual care; Intervention group: group that had access to the WBV intervention and usual care; CSTS: chair sit to stand test; p;pvalue from Mann–Whitney U;*p<0.05 (intra group differences following Wilcoxon test); PS: probability of superiority. Table 4 Health-related quality of life and activities of daily living outcomes. Outcome measures Per protocol analysis Baseline paorb Post-intervention paorb Effect size PS Control group (n=11) Intervention group (n=11) Control group (n=11) Intervention group (n=11) EQ-5D EQ-5Dmobility,problems (%) 63.60 36.40 0.201b90.90 0.00 <0.001b0.913 – EQ-5Dself-care,problems (%) 18.20 9.10 0.534b27.30 9.10 0.269b0.235 – EQ-5Ddaily life activities,problems (%) 27.30 0.00 0.062b27.30 0.00 0.062b0.397 – EQ-5Dpain/discomfort,problems (%) 72.70 90.90 0.269b72.70 54.50 0.375b0.188 – EQ-5Danxiety,problems (%) 27.30 9.10 0.269b27.30 0.00 0.062b0.397 – EQ-5Dutility 0.78 (0.15) 0.88 (0.10) 0.215a0.78 (0.07) 0.89 (0.12) *<0.001a−0.774 96 EQ-5DVAS 70.00 (45.00) 80.00 (35.00) 0.763a70.00 (20.00) 90.00 (20.00)*0.014a−0.524 80 Barthel index Total 85.00 (30.00) 95.00 (10.00) 0.069a85.00 (20.00) 100.00 (5.00) 0.003a−0.640 89 Independent, yes (%) 27.3 45.5 0.455b0.00 63.6 <0.001b0.683 – Intent to treat analysis Baseline paorb Post-intervention paorb Effect size PS Control Group (n=15) Intervention Group (n=14) Control group (n=15) Intervention group (n=14) 71.4 46.7 0.176b92.9 20.0 <0.001b0.732 – 14.3 13.3 0.941b21.4 13.3 0.564 b0.107 – 28.6 6.7 0.119b35.7 6.7 0.054 b0.358 – 78.6 80.0 0.924b78.6 46.7 0.077 b0.328 – 21.4 6.7 0.249b21.4 0.0 0.058 b0.351 – 0.78 (0.16) 0.87 (0.10) 0.111a0.76 (0.07) 0.88 (0.13)*<0.001 a−0.689 91 77.5 (45.75) 80.00 (40.00) 0.860a80.00 (24.5) 90.00 (25.00)*0.131 a−0.280 66 85.00 (26.25) 95.00 (10.00) 0.247a85.00 (20.00) 100.00 (5.00) 0.006 a−0.515 80 35.7 46.7 0.833b14.3 66.7 0.004 b0.531 – Values are median (IQR) unless otherwise stated; Control group: group that had access to usual care; Intervention group: group that had access to the WBV intervention and usual care; CSTS: Chair Sit to Stand Test; Independent: Barthel index= 100; pa:pvalue from Mann–Whitney U;pb:pvalue from x2test; *p<0.05 (intra group differences following Wilcoxon test); PS: probability of superiority. Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 6F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx investigated the feasibility and effectiveness of WBV therapy in286 nursing home residents over the age of 80 years. Of interest in287 this study is the fact that fall-related risk factors, performance in288 daily life activities and health-related quality of life outcomes were289 included and assessed in the same group of participants so that290 more certain conclusions might be achieved. The main findings291 in the current study were the enhancements in fall risk-related292 factors, performance of the daily life activities and health-related293 quality of life in institutionalized octogenarians after 8-weeks of294 WBV therapy. Hence, the results of this study are promising and of295 value to people working in nursing home facilities.296 One of the novelties of this study was to test the effects of WBV297 on lower limb muscle performance (i.e., peak power, peak veloc-298 ity and strength) during a test that simulates a real daily life task299 (i.e., sit to stand test). To the best of our knowledge, this is the300 first study analyzing the effects of a WBV therapy on the lower301 limb muscle performance outcomes using a functional test among302 institutionalized older adults. After the program, participants in303 the intervention group increased their skeletal muscle power. This304 result is of importance because it has been previously reported that305 skeletal muscle power decreases before strength with advancing 306 age [36] and also, skeletal muscle power seems to be more related307 to functionality than muscle strength in older adults [37]. Wilcoxon308 test derived effect size (not reported in tables) was r=0.57 for309 power which is considered large. Therefore, even though our par-310 ticipants did not improve lower limb strength, the TUG test score311 improved at 8-week follow-up. This is in accordance with previ-312 ous RCTs testing the effects of WBV among nursing home residents313 [22,24]. It has been previously hypothesized that in response to314 the vibration stimulus (tonic vibratory reflex), more motor units315 are activated leading to a better neuromuscular response [38]. This 316 hypothesis may help, at least in part, to explain the power output317 increases observed in the current study [39] and the subsequent318 TUG test score improvement [40].319 The TUG test and the 30-s CSTS test (number of times) were320 assessed at baseline, 2, 4, 6 and 8-week follow-up. Interestingly,321 although there was a trend toward the improvement across the322 different assessments points in both tests (i.e., we found statistical323 significant differences between baseline and the 8-week treat324 ment), we failed to find any significant difference between the last 325 points of assessment. This was especially true in the case of the326 30-s CSTS test where only significant differences were detected327 between the first assessment point (i.e., baseline) and the rest of328 the assessments points (i.e., 2,4,6 and 8 weeks) but no differences329 were detected between these last assessment points. Similarly, the330 TUG score improved between the first assessment point and the 331 rest of the assessment points and slightly did so (but still signif-332 icantly) between the second point of assessment and the 6and333 8-week assessment. Also, the TUG score improved between the 6-334 week and final assessment. This may suggest that a high dose of335 WBV should better enhance the lower limb muscle performance336 and mobility. However, considering that we designed the exer-337 cise to be safe for the patients, we decided to start in the lower 338 range (30Hz) and progressed to 35Hz for the last 4-week period339 with slight variation in time application of the bouts every 2 weeks.340 Future studies should test how less conservative doses (e.g. higher341 frequencies) of WBV affect the outcomes assessed in the current 342 study among the studied population. Nevertheless, after treatment343 effect sizes for both TUG and 30-s CSTS test (number of times)344 (r=0.76 and r=0.77, respectively) were considered large, with a 345 probability of superiority of 96% [35]. That means that the proba346 bility of success at improving the performance in the TUG test of 347 those participants allocated in the intervention group as compared348 to those participants in the control condition is 96%.349 On the other hand, the results of the postural stability test 350 showed that WBV did not have a significant effect on static351 balance. This could reflect the aforementioned effects of a conser352 vative dose of WBV. Also, the fact that the nature of the exercise 353 program performed on the vibration device was dynamic exercise 354 can support the lack of improvement in statics tests, thus, suppor355 ting the improvement in dynamic tests (TUG test). Another, more 356 comprehensive possible reason is that balance is controlled by a 357 combination of sensory, neuromuscular and biomechanical factors 358 [41]. Although WBV can improve biomechanical factors like muscle 359 strength,power,andflexibility,whichmayresultinapositiveeffect 360 on the dynamic performance (as reflected by the improvements in 361 the lower limb muscle performance and the improvements seen 362 in the TUG score in the current study), it may not have the same 363 effect on sensory factors, especially for older adults over 80 years 364 who normally have a significant decline of the sensory-motor func365 tions.Another plausibleexplanation forthe lackofpositivefindings 366 regarding postural stability could be the type of vibration used in 367 this study (i.e., vertical stimulation) as other studies on other clin368 ical populations have found positive effects on postural stability 369 using reciprocal stimulation [14,42,43].370 Unsurprisingly, participants in the intervention group reported 371 a better performance in their activities of daily living after the 372 8-week treatment. This could reflect the improvement in their 373 dynamic balance and in their lower limb muscle performance, 374 thus leading to more freedom in their daily life activities routine 375 and preventing disability [40]. Consequently, participants in the 376 study reported improvements in their health-related quality of 377 life, mainly in the mobility dimension and the anxiety/depression 378 dimension of the EQ-5D questionnaire. This could reflect the afore379 mentioned performance in daily life activities, thereby reducing 380 the anxiety/depression levels among the participants in the study 381 [44]. The only study analyzing the effects of WBV among nursing 382 home residents obtained similar results using the SF-36 question383 naire [22]. The effect sizes calculated in the current study range 384 from medium to large for these before commented variables. Thus, 385 our results strengthen the idea that appropriate WBV can prevent 386 and even improve the decline of health-related quality of life with 387 aging [45] 388 Some limitations need to be acknowledged. The small sample 389 size could limit the generalization of the results. Despite this, this 390 study was carried out as a pilot trial to determine the feasibil391 ity of the program and to determine the direction of future, large 392 trials. Due to the small sample size it was not possible to deter393 mine the optimal dose-response of the WBV, thus this question 394 still remains unknown. Another shortcoming is that our partici395 pants wear their own shoes so a potential damping of the vibration 396 could be noticed. Also, the comparison of this kind of therapy with 397 other successful ones, such as multi-component exercise inter398 ventions [40], is required. We did not record the number of falls 399 in each group but the results showed in the current study might 400 indicate a reduction in risk of falling. One might think that the 401 performed exercise on the vibration platform could be consid402 ered low intensity resistance training or that WBV dose applied 403 was also low. However, these aspects support the fact that we 404 designed the exercise to be safe for and tolerable by the patients. 405 The lack of a third group performing the same program of exer406 cise on the same machine but without vibration does not allow for 407 more certain conclusions. However, another previously published 408 study comparing the effects of dynamic exercise with and without 409 vibrationon functionamonginstitutionalizedolderadults hasyield 410 some promise results [21]. Future studies might consider includ411 ing some outcomes regarding satisfaction with treatment. Further 412 cost-effectiveness analysis is warranted to enhance the decision413 making process of policy makers on the implementation of this 414 type of intervention in nursing home settings. This research line 415 can clearly be heightened by a multi-centric approach involving 416 a large sample size allowing us to answer all of these remaining 417 Please cite this article in press as: Álvarez-Barbosa F, et al. Effects of supervised whole body vibration exercise on fall risk factors, functional dependence and health-related quality of life in nursing home residents aged 80+. Maturitas (2014), http://dx.doi.org/10.1016/j.maturitas.2014.09.010 ARTICLE IN PRESS G Model MAT62551–8 F. Álvarez-Barbosa et al. / Maturitas xxx (2014) xxx–xxx 7 questions. This could allow for the development of more specific418 WBV interventions designed for specific subgroups with different419 frailty levels.420 5. Conclusion421 The application of an 8-wk WBV-based intervention in a nurs-422 ing home setting is feasible and effective to reduce fall risk factors, 423 improve performance in activities of daily living and increase424 health-related quality of life in nursing home residents over the425 age of 80 years. In practice, these findings could operate as a model426 for nursing home practitioners to implement WBV as an exercise427 based management intervention for residents in nursing homes.428 ContributorsQ4429 J.P.C and B.P.C designed the study and directed its implementaQ5430 tion, including quality assurance and control. R.A.R and Y.Z helped431 supervisethe fieldactivitiesanddesignedthe study’sanalyticstrat-432 egy. F.A.B helped conduct the literature review and prepare the433 introduction, Materials and Methods sections on the text. M.E.R. 434 prepared the discussion and helped in stat analysis. All authors435 approved the final version of the manuscript.436 Competing interest437 The authors declare no conflict of interest.438 Funding439 Author disclosures: No financial disclosures were reported by440 the authors of this paper. The work is original and has not been441 presented or published elsewhere. There are not financial benefits 442 to the authors. 443 References444 [1] Akyol AD. Falls in the elderly: what can be done? Int Nurs Rev 2007;54:191–6.445 [2] Petridou ET, Kyllekidis S, Jeffrey S, Chishti P, Dessypris N, Stone DH. Uninten-446 tional injury mortality in the European Union: how many more lives could be447 saved? Scand J Public Health 2007;35:278–87.448 [3] Health Quality Ontario. Prevention of falls and fall-related injuries inQ6449 community-dwelling seniors: an evidence-based analysis. Ont Health Technol450 Assess Ser 2008;8:1–78. 451 [4] Iglesias CP, Manca A, Torgerson DJ. The health-related quality of life and cost452 implications of falls in elderly women. Osteoporos Int 2009;20:869–78.453 [5] Cameron ID, Murray GR, Gillespie LD, Robertson MC, Hill KD, Cumming RG,454 et al. Interventions for preventing falls in older people in nursing care facilities455 and hospitals. Cochrane Database Syst Rev 2010:CD005465.Q7456 [6] Chu LW, Chiu AY, Chi I. Impact of falls on the balance, gait, and activities of daily 457 living functioning in community-dwelling Chinese older adults. J Gerontol Ser458 A Biol Sci Med Sci 2006;61:399–404. 459 [7] Janssen I, Heymsfield SB, Ross R. Low relative skeletal muscle mass (sarcope-460 nia) in older persons is associated with functional impairment and physical461 disability. J Am Geriatr Soc 2002;50:889–96.462 [8] Joyner MJ. Muscle strength, body composition, hormones, and aging. Exerc463 Sport Sci Rev 2005;33:61–2.464 [9] Kadono N, Pavol MJ. Effects of aging-related losses in strength on the ability to465 recover from a backward balance loss. J Biomech 2013;46:13–8.466 [10] Nitz JC, Josephson DL. Enhancing functional balance and mobility among older 467 people living in long-term care facilities. Geriatr Nurs 2011;32:106–13.468 [11] Rose DJ, Hernandez D. The role of exercise in fall prevention for older adults. 469 Clin Geriatr Med 2010;26:607–31.470 [12] Karlsson MK, Vonschewelov T, Karlsson C, Coster M, Rosengen BE. Prevention 471 of falls in the elderly: a review. Scand J Public Health 2013;41:442–54.472 [13] Granacher U, Muehlbauer T, Gollhofer A, Kressig RW, Zahner L. Evidence-based473 and evidence-inspired: an intergenerational approach in the promotion of bal-474 ance and strength for fall prevention. Gerontology 2011;57:424–6. 475 [14] Gusi N, Carmelo Adsuar J, Corzo H, Del Pozo-Cruz B, Olivares PR, Parraca JA.476 Balance training reduces fear of falling and improves dynamic balance and 477 isometric strength in institutionalised older people: a randomised trial. J Phys478 iother 2012;58:97–104. 479 [15] SherringtonC, WhitneyJC, LordSR,Herbert RD,Cumming RG,Close JC.Effective 480 exercise for the prevention of falls: a systematic review and meta-analysis. J 481 Am Geriatr Soc 2008;56:2234–43. 482 [16] Sherrington C, Tiedemann A, Fairhall N, Close JC, Lord SR. Exercise to prevent 483 falls in older adults: an updated meta-analysis and best practice recommenda484 tions. NSW Public Health Bull 2011;22:78–83. 485 [17] Pollock RD, Martin FC, Newham DJ. Whole-body vibration in addition 486 to strength and balance exercise for falls-related functional mobility of 487 frail older adults: a single-blind randomized controlled trial. Clin Rehabil 488 2012;26:915–23. 489 [18] Bogaerts AC, Delecluse C, Claessens AL, Troosters T, Boonen S, Verschueren SM. 490 Effectsofwhole bodyvibrationtrainingon cardiorespiratoryfitnessandmuscle 491 strength in older individuals (a 1-year randomised controlled trial). Age Ageing 492 2009;38:448–54. 493 [19] Rogan S, Hilfiker R, Herren K, Radlinger L, de Bruin ED. Effects of whole-body 494 vibrationonpostural controlin elderly: asystematic review andmeta-analysis. 495 BMC Geriatr 2011;11:72. 496 [20] Lam FM, Lau RW, Chung RC, Pang MY. The effect of whole body vibration on bal497 ance, mobility and falls in older adults: a systematic review and meta-analysis. 498 Maturitas 2012;72:206–13. 499 [21] Bautmans I, Van Hees E, Lemper JC, Mets T. The feasibility of whole 500 body vibration in institutionalised elderly persons and its influence on 501 muscle performance, balance and mobility: a randomised controlled trial 502 [ISRCTN62535013]. BMC Geriatr 2005;5:17. 503 [22] Bruyere O, Wuidart MA, Di Palma E, Gourlay M, Ethgen O, Richy F, et al. 504 Controlled whole body vibration to decrease fall risk and improve health505 related quality of life of nursing home residents. Arch Phys Med Rehabil 506 2005;86:303–7. 507 [23] Bogaerts A, Delecluse C, Boonen S, Claessens AL, Milisen K, Verschueren SM. 508 Changes in balance, functional performance and fall risk following whole 509 body vibration training and vitamin D supplementation in institutionalized 510 elderly women. A 6 month randomized controlled trial. Gait Posture 2011;33: 511 466–72. 512 [24] Beaudart C, Maquet D, Mannarino M, Buckinx F, Demonceau M, Crielaard JM, 513 et al. Effects of 3 months of short sessions of controlled whole body vibra514 tions on the risk of falls among nursing home residents. BMC Geriatr 2013; 515 13:42. 516 [25] Buckinx F, Beaudart C, Maquet D, Demonceau M, Crielaard JM, Reginster JY, 517 et al. Evaluation of the impact of 6-month training by whole body vibration 518 on the risk of falls among nursing home residents, observed over a 12-month 519 period: a single blind, randomized controlled trial. Aging Clin Exp Res 2014. 520 [26] Podsiadlo D, Richardson S. The timed “Up & Go”: a test of basic func521 tional mobility for frail elderly persons. J Am Geriatr Soc 1991;39: 522 142–8. 523 [27] Yumin ET, Simsek TT, Sertel M, Ozturk A, Yumin M. The effect of functional 524 mobility and balance on health-related quality of life (HRQoL) among elderly 525 people living at home and those living in nursing home. Arch Gerontol Geriatr 526 2011;52:e180–4. 527 [28] Shumway-Cook A, Brauer S, Woollacott M. Predicting the probability for falls 528 in community-dwelling older adults using the Timed Up & Go Test. Phys Ther 529 2000;80:896–903. 530 [29] Rikli J. In: Human Kinetics, editor. Senior fitness test manual. Champaign, IL: 531 Human Kinetics; 2001. 532 [30] Thapa PB, Gideon P, Fought RL, Kormicki M, Ray WA. Comparison of clinical 533 and biomechanical measures of balance and mobility in elderly nursing home 534 residents. J Am Geriatr Soc 1994;42:493–500. 535 [31] Prieto TE, Myklebust JB, Hoffmann RG, Lovett EG, Myklebust BM. Measures 536 of postural steadiness: differences between healthy young and elderly adults. 537 IEEE Trans Biomed Eng 1996;43:956–66. 538 [32] Mahoney FI, Barthel DW. Functional evaluation: the Barthel index. MD State 539 Med J 1965;14:61–5. 540 [33] The EuroQol Group. EuroQol—a new facility for the measurement of health541 related quality of life. Health Policy 1990;16:199–208. 542 [34] Brooks R. EuroQol: the current state of play. Health Policy 1996;37: 543 53–72. 544 [35] Fritz CO, Morris PE, Richler JJ. Effect size estimates: current use, calculations, 545 and interpretation. J Exp Psychol Gen 2012;141:2–18. 546 [36] Reid KF, Fielding RA. Skeletal muscle power: a critical determinant of physical 547 functioning in older adults. Exerc Sport Sci Rev 2012;40:4–12. 548 [37] Pereira A, Izquierdo M, Silva AJ, Costa AM, Gonzalez-Badillo JJ, Mar549 ques MC. Muscle performance and functional capacity retention in older 550 women after high-speed power training cessation. Exp Gerontol 2012;47: 551 620–4. 552 [38] Cardinale M, Bosco C. The use of vibration as an exercise intervention. Exerc 553 Sport Sci Rev 2003;31:3–7. 554 [39] Cadore EL, Izquierdo M, Conceicao M, Radaelli R, Pinto RS, Baroni BM, et al. 555 Echo intensity is associated with skeletal muscle power and cardiovascular 556 performance in elderly men. Exp Gerontol 2012;47:473–8. 557 [40] Cadore EL, Casas-Herrero A, Zambom-Ferraresi F, Idoate F, Millor N, Gomez 558 M, et al. Multicomponent exercises including muscle power training enhance 559 muscle mass, power output, and functional outcomes in institutionalized frail 560 nonagenarians. Age (Dordr) 2013. 561 [41] Woollacott MH, Tang PF. Balance control during walking in the older adult: 562 research and its implications. Phys Ther 1997;77:646–60. 563 [42] Adsuar JC, Del Pozo-Cruz B, Parraca JA, Olivares PR, Gusi N. Whole body 564 vibration improves the single-leg stance static balance in women with 565