CRITICALLY APPRAISED PAPER (CAP) Taylor, D., Hale, L., Schuler, P. Waters, D., Binns, E., McCracken, H.,...Wolf, S. L. (2012). Effectiveness of tai chi as a community-based falls prevention intervention: A randomized controlled trial. Journal of the American Geriatric Society, 60, 841 848. http://dx.doi.org/10.1111/j.1532-5415.2012.03928.x CLINICAL BOTTOM LINE: Briefly discuss how the evidence relates to occupational therapy practice (i.e., within the scope of traditional or emerging practice) AND how can practitioners use the evidence relative to the target population and practice setting. Falls prevention and reduction in the older adult population has become a focus of health strategies in many countries, and numerous research studies have investigated this issue. In the above study, the researchers wanted to determine if the level of intensity of a tai chi intervention had an effect on falls reduction as compared to a low-level exercise group. They utilized a randomized controlled trial with three groups of participants from communities throughout New Zealand. The participants were at least 65 years of age and either were at-risk for falls as determined by the Falls Risk Assessment Tool or had fallen within the last 12 months. The researchers randomly assigned participants to one of three groups. Two of the groups received instruction in a modified form of Sun Style tai chi in a group format either once or twice a week for 1-hour sessions for 20 weeks. The third group was a control group that received a group exercise program of gentle lower extremity stretching, strengthening, and lowlevel or seated cardiovascular exercises once a week for the same amount of time. This control group did not receive any intervention that targeted balance training. The researchers focused on the number of reported falls as their primary outcome measure during the study. Secondary outcomes included strength, mobility, and balance. Participants were responsible for recording their falls each month as they occurred on calendars that were provided. The Timed Up and Go (TUG), the step test, and the 30-Second Chair test were the secondary outcome measures to determine mobility, balance, and lower extremity at baseline, after the study, and at 11 and 17 months. The researchers found that the results indicated that all of the groups displayed a 58% mean fall reduction rate over the 17 months. However, there was no difference in fall rates between the intervention groups and control group during the study. 1
Mobility did not change over the study for any group and balance improved at the same rate over time across all groups. The Chair Test demonstrated that over time, all participants were able to increase their number of chair stands (p <.001), but with no significant group difference at baseline or with time by group. This study demonstrated that a modified tai chi program as well as regular gentle physical exercise might equally contribute to decreased fall rates among the older adult population. It was suggested in the study that the link among social engagement, participation, and health outcomes played a role in the community-based program. As occupational therapists, it would be beneficial to further study the role of group activities and exercise in increasing overall health and decreasing the incidence of falls in the at-risk older adult population. RESEARCH OBJECTIVE(S) List study objectives. Determine whether a tai chi intervention program delivered at two levels of intensity as compared to a low-level exercise program reduces the number of falls in a community-based older adult population that is at risk for falls. DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. Participants were recruited with community advertising in newspapers, radio, and television, as well as flyers in doctors offices, libraries, and other community sites from three New Zealand cities: Auckland, Dunedin, and Christchurch. Participants contacted the researchers by phone if they wanted to participate. Inclusion Criteria Participants were at least 65 years old (55 if Maori or Pacific Islander due to health disparities between the ethnicities) and community-dwelling. They either had fallen in the last 12 months or were at high risk of falling as determined by a Falls Risk Assessment Tool score of 1 or more. The subjects had to have approval from their primary physician to participate in a low to moderate level exercise group. Exclusion Criteria Exclusion criteria included: inability to ambulate independently, severe cognitive deficits as defined by a score less than 23 on the Telephone Mini Mental State Exam, chronic medical conditions making exercise difficult, or involvement in tai chi or any exercise program targeting strength and balance presently or within the last year. 2
SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) 684 #/ (%) Male 182 (27%) #/ (%) Female 502 (73%) Ethnicity All ethnic groups in New Zealand, including Maori and Pacific Islander Disease/disability diagnosis Participants were older adults living in the community who had fallen or were at risk for falls. 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? Intervention included 1 hour of modified Sun-style group tai chi classes 233 Various community sites in Auckland, Dunedin, and Christchurch Experienced tai chi instructors who had attended training by the Accident Compensation Corporation (ACC) on the modified 10- form Sun tai chi program. Participant-to-instructor ratio was 15:1. 1 time per week 20 weeks with follow-up assessments at 11 and 17 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? Intervention included 1 hour of modified Sun-style group tai chi classes 220 Various community sites in Auckland, Dunedin, and Christchurch Experienced tai chi instructors who had attended training by the Accident Compensation Corporation (ACC) on the modified 10- form Sun tai chi program. Participant-to-instructor ratio was 15:1. 2 times per week 20 weeks with follow-up assessments at 11 and 17 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? Intervention included a 1-hour low-intensity lower extremity group exercise program, which served as the control group. The class involved low-level strengthening, stretching, and cardiovascular exercises, often while seated. The participants did not perform any exercises that specifically addressed balance. 231 Various community sites in Auckland, Dunedin, and Christchurch Trained exercise instructors who followed a manual outlining the program 1 time per week 20 weeks with follow-up assessments at 11 and 17 months Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: YES NO The study did not allow for any overlap in time for the classes so there would not be any cross-contamination. Co-intervention: YES NO Timing: YES NO Site: To decrease potential for co-intervention, exclusion criteria for the study included participation in an exercise or tai chi program presently or in the last year. The researchers utilized 11 community sites in 3 cities. There was no description or homogeneity of sites discussed. 4
Use of different therapists to provide intervention: The study utilized different instructors at the different sites providing the opportunity for intervention delivery bias. However, each instructor was trained with the same program. MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? To measure primary outcomes, the researchers used a self-report falls calendar. They asked the participants to record and report falls as defined by the study in individual fall calendars. If the participant forgot to turn in the monthly calendar, the researchers would call within 2 weeks and researchers blinded to group involvement collected the data by phone. Incidence of falls YES NR YES NR The participants recorded the number of falls they sustained every month for 17 months on calendars that they turned in to the researchers. Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? Timed Up and Go (TUG) test Functional mobility/ balance At baseline, after the 20-week intervention, and at the 11- and 17-month follow-up sessions Step Test Dynamic balance At baseline, after the 20-week intervention, and at the 11- and 17-month follow-up sessions 5
Measure 2: Name/type of measure used: What outcome was measured? reliable? valid? When is the measure used? 30-Second Chair test Lower extremity strength At baseline, after the 20-week intervention, and at the 11- and 17-month follow-up sessions Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. Recall or memory bias. Check yes, no, or NR, and if yes, explain. On the self-report falls calendar, there is a possibility of decreased accuracy of recall of the events. Others (list and explain): The study lists possible bias because ACC was a funding source and participants may have wanted the program to continue so would give positive results. RESULTS List key findings based on study objectives Include statistical significance where appropriate (p < 0.05) Include effect size if reported Using an adjusted negative binomial regression analysis of number of falls per intervention group, the researchers found no statistically significant difference between the groups: tai chi intervention 1 time per week (TC1), tai chi intervention 2 times per week (TC2), and low-level exercise-control group (LLE). The incident rate ratio (IRR) between groups was as follows: TC1 (p =.36) and LLE (P = 0.70), and TC2 (p =.23) and LLE (p = 0.37). Monthly falls data using an adjusted multilevel mixed-effect Poisson regression analysis showed no difference in baseline fall rates (p =.13) between groups or over time between groups (p = 25). However, there was a significant falls reduction rate for all groups over time as evidenced. in the mean logarithm fall rate per month of -0.050 (95% CI = -0.064 to -0.037, p <.001). This represents a 58% falls reduction rate over the length of the study for all groups. 6
A multilevel mixed effect analysis of the TUG data displayed no significant group difference at baseline or with time between groups. The step test right and left leg displayed a significant increase in the number of steps with right and left leg over time using a multilevel mixed-effects analysis, but no significant differences between groups. Attendance rates for the exercise programs during the intervention were as follows: TC1 79% interquartile range (IQR) 49% 90%; TC2 72% (IQR 44% 88%); and LLE 67% IQR (10% 85%). At the 11- and 17- month follow-up assessments, all groups had decreased exercise numbers without a significant difference between groups. There were no serious adverse reactions reported by participants in the interventions or control group other than complaints of aches and pains (11 participants in the LLE, 19 in TC1, and 15 in TC2 group). Continuation of some sort of weekly exercise reported at 11 months was 53% for TC1, 64% for TC2, and 63% for LLE. At 17 months, these numbers had decreased for all groups to 49% TC1, 43% TC2, and 58% LLE. The researchers noted significantly more missing data in the LLE group than in the TC1 or TC2 group at baseline: LLE (n = 22, 9.5%) compared to TC1 (n = 12, 5.2%, p =.001) and compared to TC2 (n = 11, 5.0%, p =.005). The researchers considered that those who fell might withdraw which would increase the size of the falls reduction rates. They calculated that participants were 1.43 times more likely to withdraw if they had fallen (95% confidence interval (CI): 0.94 2.17) than participants who did not (p =.10). Treatment group did not seem to significantly affect withdrawing (p =.48). Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. The researchers performed power calculations and adjusted the number of participants in each group based on fall rate data from similar studies of fall rates in community-dwelling seniors at risk for falls. The researchers also calculated for the expected attrition rate and adjusted the numbers accordingly. Were appropriate analytic methods used? Check yes, no, or NR, and if no, explain. Were statistics appropriately reported (in written or table format)? Check yes or no, and if no, explain. Was the percent/number of subjects/participants who dropped out of the study reported? 7
Limitations: What are the overall study limitations? There was no inactive control group to compare to the active exercise group. The results are limited in application to community-based older adults who had fallen or were at risk of falling. Another limitation that the researchers noted was that there were more missing data from the LLE control group than from the other two groups. They also noted multiple tai chi and exercise instructors being a possible limitation of the study. The authors also note that in a recent metaanalysis of tai chi as an intervention for falls prevention, 50 hours of tai chi is needed to show an effective difference in number of falls (Logghe et al., 2010). In this study, the TC1 and LLE groups only received approximately 14 16 hours of exercise and the TC2 group approximately 28 32 hours of exercise. CONCLUSIONS State the authors conclusions related to the research objectives. The authors concluded that there is no statistically significant difference in reported fall rates between the tai chi intervention (at either intensity) and the low-level exercise group for community-dwelling older adults. However, all three groups of participants reported reduction in their fall rates during this study and at the 11- and 17-month follow up. Additionally, 60% of participants continued with some form of physical exercise after the intervention. No one group participated more than the others did. The authors discussed the valuable role of participation in physical activity and social engagement in-group activities as an important factor in health maintenance and falls reduction. Further research investigating this complex relationship may be warranted. This study supports the idea that community-based group exercise can be effective in reducing falls in community-dwelling seniors at risk for falls. Reference Logghe, I. H. J., Verhagen, A. P., Rademaker, A. C. H. J., Bierma-Zeinstra, S. M. A., van Rossum, E., Faber, M. J., & Koes, B. W. (2010). The effects of Tai Chi on fall prevention, fear of falling, and balance in older people: A meta-analysis. Preventative Medicine, 51, 222 227. http://dx.doi.org/10.1016/j.ypmed.2010.06.003 This work is based on the evidence-based literature review completed by Cheryl Mott MS, OTR/L, CLVT, 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