CRITICALLY APPRAISED PAPER (CAP) Clemson, L., Fiatarone Singh, M. A., Bundy, A., Cumming, R. G., Manollaras, K., O Loughlin, P., & Black, D. (2012). Integration of balance and strength training into daily life activity to reduce rate of falls in older people (the LiFE study): Randomized parallel trial. British Medical Journal, 345, e4547. http://dx.doi.org/10.1136/bmj.e4547 CLINICAL BOTTOM LINE: The rate of institutionalization due to falls has not decreased in the past 10 years, and it is essential to develop effective strategies for fall prevention for the older population. Active participation in strengthening and balancing activities are found to improve functional competencies. However, less than 10% of the older population routinely engage in fall prevention activities. The implication of incorporating balancing and strengthening activities into daily routine practice would be helpful in fall prevention. Currently, there is no research study on the effectiveness of such an approach in older people who are at risk of falling. Therefore, the researchers in this study investigated the effectiveness of the Lifestyle integrated Functional Exercise (LiFE) program for fall reduction. The researchers conducted a three-arm randomized parallel trial, with measurement assessed at baseline, 6 months, and 12 months. Intervention groups included home-based LiFE approach, structured program, and sham control program. The LiFE and structured programs provided graded balancing and strengthening exercises over 5 intervention sessions, 2 booster visits and 2 phone calls, whereas the controlled program provided 3 home visits sessions and 6 phone calls. All interventions were provided by trained physiotherapists and occupational therapists. The strategies of the LiFE approach focused on developing a new habitual daily routine by integrating graded balancing and strengthening exercises into daily activities. The balance approaches of the LiFE included static and dynamic standing balance, weight shifting, narrowing the base for standing support, and rotating the body in different directions. The strengthening approaches of the LiFE included bearing weight on the toes or heels, squeezing muscles, making squads, and stepping sideways. The participants were encouraged to practice the exercises when they could throughout the day. 1
The outcome of the LiFE approach was significant, with a 31% fall reduction compared to the controlled programs for the older adults aged 70 or older who lived at home more than 1 year. The secondary outcome measurements between the LiFE program and control group were significant in eight level balance hierarchy (p <.0001), five level balance hierarchy (p =.001), Chatillom DMG250 modified dynamometer (right ankle strength p =.005, left ankle strength p <.001), and Activities Specific Balance Confidence Scale (p =.004). The LiFE program contributes to the awareness and idea for possible intervention of integrating graded strengthening and balance training into daily activities, which can be practiced any time of the day to reduce falls in the older population. RESEARCH OBJECTIVE(S) List study objectives. To determine whether a lifestyle integrated approach to balance and strength training is effective in reducing the rate of falls in older, high-risk people living at home over a year. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Three arm, randomized parallel trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Subjects were selected to participate from the Department of Veteran s Affairs (DVA) databases. Invitations were sent to veterans, their spouses, or widows in the urban area of Sydney, Australia, and the general practice databases. Inclusion Criteria Older adults age 70 years or older with 2 or more falls or one injurious fall in the past 12 months noted by self-report. Exclusion Criteria Older adults with moderate to severe cognitive problems, inability to move about independently due to neurological condition that greatly affect their gait and mobility, and those with no conversational English skills were excluded. Residents living in a nursing home or hostel and any older adults with terminal illness that would make it impossible to perform the planned exercises were excluded from participating. SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 317 #/ (%) Male 143/ (45%) #/ (%) Female 174/ (55%) 2
Ethnicity NR Disease/disability diagnosis Sustained 2 or more falls or one injurious fall in the past 12 months. INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? The LiFE Program embedded graded balance and strengthening exercises into habitual daily activities that the participants performed multiple times during the day. The participant manuals were provided as examples for individualized intensity adjustment, which included prescribed graded balance strategies over time to integrate into daily activities with base of support reduction, weight shifting, directional changing, and stepping over items. In addition, the adjustment contained prescribed graded strengthening strategies over time to integrate into daily activities with resistive lower extremities movement focusing on applying body weight on knees and toes, muscle tightening, and sideways walking. 107 Home at metropolitan area Physiotherapists and occupational therapists 7 sessions, 2 follow-up phone calls 6 months Group 2 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Structured Program: Prescribed 7 graded exercises for balance and 6 graded for lower extremities strengthening exercises with ankle cuff weights to be performed 3 times a week. 105 Home at metropolitan area Physiotherapists and occupational therapists 7 sessions, 2 follow-up phone calls 6 months 3
Group 3 Brief description of the intervention How many participants in the group? Where did the intervention take place? Who delivered? How often? For how long? Control: Non-graded 12 gentle and flexibility exercises while seated, supine, or standing while holding on support. 105 Home at metropolitan area Physiotherapists and occupational therapists 3 sessions, 6 follow-up phone calls 6 months Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NO Comment: The structured and control groups were not exposed to the LiFE program because all group participants received the interventions individually at their homes. Co-intervention: Comment: The research study ensured that the participants did not have involvement with other fall prevention programs. Timing: YES NO Site: Comment: Comment: Interventions did not occur in a standardized environment. Use of different therapists to provide intervention: Comment: The physiotherapists and occupational therapists were trained for intervention deliveries. 4
MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Daily Calendar Numbers of falls Monthly for 12 months Measure 2: Short Physical Performance Battery Balance test (5-level scale) Static balance Assessment at baseline, at 6 and 12 months Measure 3: Measure 4: Physical Performance Battery Balance test (8-level scale) Static balance Assessment at baseline, at 6 and 12 months Chatillom DMG250 modified dynamometer with removable stand Lower limb strength with the highest of three measurements 5
Measure 5: Assessment at baseline, at 6 and 12 months Activities Specific Balance Confidence (ABC) Scale Self-efficacy in balance Assessment at baseline, at 6 and 12 months. Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Comment: Recall or memory bias. Check yes, no, or NR, and if yes, explain. Comment: Fall history may be subjected to recall bias. Others (list and explain): RESULTS List key findings based on study objectives Include statistical significance where appropriate (p <.05) Include effect size if reported Daily Calendar: 172 falls (21 fell once, 39 fell at least twice, 1.66 falls per person) in the LiFE group in 12 months; 193 falls (24 fell once, 41 fell at least twice, 1.90 falls per person) in the structured exercise group in 12 months; 224 falls (26 fell once, 45 fell at least twice, 2.28 falls per person) 6
in the control group in 12 months. There was a significant fall reduction (95% CI 0.48-0.99) when comparing the LiFE program with the control group. However, there was no significance in fall reduction when comparing between the structured group and the control group (95% CI 0.81). Five level balance hierarchy: LiFE vs. control: p =.001, effect size =.55; structured vs. control: p =.04, effect size =.33. The balance outcomes from the LiFE program were considered moderate to large effect sizes in comparison to the control group, whereas the balance outcomes found moderate effect size between the structured group and the control group. Eight level balance hierarchy: LiFE vs. control: p <.0001, effect size =.63; structured vs. control: p =.08, effect size =.29. The balance outcomes from the LiFE program were considered moderate to large effect sizes in comparison to the control group, whereas the balance outcomes found small to moderate effect sizes between the structured group and the control group. Chatillom DMG250 dynamometer LiFE vs. control (right ankle strength): p =.005, effect size =.40; structured vs. control (right ankle strength): p =.10, effect size =.26. LiFE vs. control (left ankle strength): p <.001, effect size =.40; structured vs. control (left ankle strength): p =.34, effect size =.17. Significant progress in ankle strength with medium to large effect size was shown in comparing the LiFE program to the control group. Authors reported no significant improvement for the right and left knee strength and hip strength. Activities Specific Balance Confidence Scale: LiFE vs. control: p =.004, effect size =.38; structured vs. control: p =.006, effect size =.37. The outcomes of the balance confidence scale from the LiFE program were considered moderate to large effect sizes in comparison to the control group, as well as between the structured group and the control group. The patterns for poor adherences in the first 6 months include LiFE group 7%, structured group 19%, and control group 12%. At 12 months, 64% of participants in the LiFE program, 53% of participants in the structured program, and 53% of participants in the control program were still exercising. The adherence in the structured group was lower than the LiFE group and the control group. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. YES NO Comment: Authors indicated that the sample size for the study was small. 7
Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Comment: Intention to treat analysis was used due to the frequency. Causes of missed assessments were similar between groups, which allowed realistic estimation of the advantage of a treatment variation. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Comment: Was the percent/number of subjects/participants who dropped out of the study reported? Limitations: What are the overall study limitations? The slightly small sample size might lead to type II error. The confidence interval was close to 1 when comparing the significant fall reduction between the LiFE program and the control group, indicating that further research study with careful interpretation on the results for the LiFE program is recommended. The exercises for the control group were not graded and the effect of the program among fall reduction could be disputable. The rate of falling was higher than expected, which decreased the appropriate sample size needed for the study. CONCLUSIONS State the authors conclusions related to the research objectives. The LiFE program showed significant fall reduction in comparison to the control group for participants ages 70 or older at home for more than 1 year. The program produced affirmative effects, including increased energy levels and performance in activities and improved life participation. This intervention provides an additional option to ordinary fall prevention programs by incorporating both balance and strengthening training into daily activities within the participants own environments for optimal outcomes in fall reduction with older adults. This work is based on the evidence-based literature review completed by Choi I Chio, OTD, OTR/L and Kitsum Li, OTD, OTR/L, Faculty Advisor, Rocky Mountain University of Health Professions. CAP Worksheet adapted from Critical Review Form--Quantitative Studies. Copyright 1998, by M. Law, D. Stewart, N. Pollack, L. Letts, J. Bosch, & M. Westmorland, McMaster University. Used with permission. For personal or educational use only. All other uses require permission from AOTA. Contact: www.copyright.com 8