CRITICALLY APPRAISED PAPER (CAP) Pitkälä, K. H., Pöysti, M. M., Laakkonen, M.-L., Tilvis, R. S., Savikko, N., Kautiainen H., & Strandberg, T. E. (2013). Effects of the Finnish Alzheimer Disease Exercise Trial (FINALEX): A randomized controlled trial. JAMA Internal Medicine, 173, 894 901. http://dx.doi.org/10.1001/jamainternmed.2013.359 CLINICAL BOTTOM LINE: This study provides Level I evidence that an intense exercise program of long duration can limit the functional decline in community-dwelling older adults with Alzheimer s disease (AD) without raising the cost of health services. It may also reduce the number of falls. Occupational therapy practitioners working with this population should strongly consider the benefits of a routine, long-term physical exercise program to improve individuals performance of daily activities and to reduce fall risk when developing intervention strategies for older adults with AD in community-based settings. Such a program may extend the time an older adult with AD is able to remain in his or her home environment. RESEARCH OBJECTIVE(S) List study objectives. To investigate the effects of intense and long-term exercise on the physical functioning and mobility of home-dwelling patients with AD and to explore its effects on the use and costs of health and social services DESIGN TYPE AND LEVEL OF EVIDENCE: Level I: Randomized controlled trial, repeated measures SAMPLE SELECTION How were subjects recruited and selected to participate? Please describe. A letter was mailed to patients who were on the AD drug reimbursement register of the Social Insurance Institution of Finland and who were living at the same address with a spouse in the neighboring cities of Helsinki, Espoo, or Vantaa. The researchers interviewed the spousal caregiver by telephone to determine whether the potential participant met inclusion criteria. 1
Inclusion Criteria AD diagnosis; shared residence with spouse; age 65 or older; no terminal disease; ability to walk (with or without aid); at least one fall during the past year, decreased walking speed, or unintentional weight loss Exclusion Criteria NR SAMPLE CHARACTERISTICS N= (Number of participants taking part in the study) N = 210 at baseline N = 151 at completion of study Dropout rate = 49 (28.1%) at 12 months #/ (%) Male 129 (61.4%) #/ (%) Female 81 (38.6%) Ethnicity White Disease/disability diagnosis AD INTERVENTION(S) AND CONTROL GROUPS Add groups if necessary Group 1: Home-based exercise group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? Goal-oriented, individualized, home-based exercise (HE group) 68 Participant s home Physiotherapists who specialized in dementia 1 hr, twice per week 12 months Group 2: Group-based exercise group Brief description of the intervention How many participants in the group? Physical exercise intervention including endurance, balance, strength training, and exercises for executive functioning in groups of 10 participants for 4-hr visits twice per week, with a mean active exercise time of 1 hr per day for each person (GE group) 61 2
Where did the intervention take place? Who Delivered? How often? For how long? Group 3: Control group Brief description of the intervention How many participants in the group? Where did the intervention take place? Who Delivered? How often? For how long? Adult day care centers Two physiotherapists who specialized in dementia 4 hr, two times per week; 1 hr per visit for each individual 12 months Control group (CG) received routine medical care plus oral and written advice on nutrition and exercise. Individuals in the CG group had the right to participate in the physiotherapy provided by the community health system. 65 Community care in Finnish health care system Community care providers in Finnish health care system As needed 12 months Intervention Biases: Check yes, no, or NR and explain, if needed. Contamination: Co-intervention: Ninety-six percent of participants were taking AD medication. Timing: Site: NR Multiple intervention sites: HE group s intervention took place in the home of each participant, GE group s intervention took place at adult day care centers, and CG group s intervention was community based 3
Use of different therapists to provide intervention: MEASURES AND OUTCOMES Complete for each measure relevant to occupational therapy: Measure 1: Name/type of Functional Independence Measure (FIM) What outcome was Physical functioning based on caregiver assessment When is the Baseline and at 3, 6, and 12 months (four occasions) Measure 2: Name/type of What outcome was When is the Measure 3: Name/type of What outcome was, When is the Short Physical Performance Battery Mobility Baseline and at 3, 6, and 12 months (four occasions) Nonstandard assessment of the frequency of complications Complications including falls, fractures, and number of hospitalizations, as reported by spousal caregivers During the 12-month intervention period 4
Measure 4: Name/type of What outcome was When is the Cost of the use of health and social services, retrieved from central registers and medical records Cost and use of health and social services by both patient and caregiver Researchers retrieved and calculated all costs and use of health and social services for 2 years after randomization into the study arms Measurement Biases Were the evaluators blind to treatment status? Check yes, no, or NR, and if no, explain. The study was not blinded, because it was impossible to blind the study nurses who were completing assessments from the arms of the study, given the location of the intervention and assessment. Recall or memory bias. Check yes, no, or NR, and if yes, explain. Study participants caregivers reported for FIM data Others (list and explain): NA RESULTS List key findings based on study objectives Include statistical significance where appropriate (p<0.05) Include effect size if reported Physical function, as measured by the FIM, declined in all three study groups, but less decline was observed in both the HE and GE intervention groups than in the CG group. The difference between the HE group and the CG group was significant at 6 months (p =.001) and 12 months (p =.004). The changes occurred in the motor portion of the FIM rather than the cognitive scores. The difference between the GE group and the CG group on the FIM was not significant at 6 months (p =.07) or at 12 months (p =.12). There were no differences between groups on mobility, as measured by the Short Physical Performance Battery. The GE group had a significantly lower cost of health and social services, as compared with the CG group. No significant difference was found in cost of health and social services between the HE and CG groups. Those in the CG group reported more falls per year; there were no 5
differences between groups on the incidence of fractures or hospitalizations. Was this study adequately powered (large enough to show a difference)? Check yes, no, or NR, and if no, explain. The small sample size and number of participants who dropped out may not provide sufficient power to detect differences between the GE and CG groups. 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? Limitations: What are the overall study limitations? Study participants were White volunteers, which limits the generalizability of the results. Additionally, participants were not blinded to intervention. Several participants were lost to follow-up. The researchers used caregiver report for assessment of physical functioning. The high-quality community care received by the CG group might have skewed the differences between groups. CONCLUSIONS State the authors conclusions related to the research objectives. In-home exercise programs may delay decline in physical functioning caused by AD, as measured by the FIM. This intervention did not increase the total cost of health services. The in-home exercise was intense, specific to each patient, performed at home, provided for 12 months, and delivered by health professionals trained in dementia care. All of these factors are potential contributors to the success of the program. The lack of significant differences in mobility performance might have been due to the 6
difficulty of the measurement tool among this patient population. The intervention provided did not increase the number of falls, fractures, or hospitalizations and therefore seems safe. It did not increase the total cost of health and social services. Long-term home-based, intense exercise programs may be useful in preventing decline in physical function for adults with AD without additional health care costs. Exercise may also reduce the risk of falls for adults with AD. Exercise programs may be beneficial for physical functioning of patients with AD, without increasing net costs. This work is based on the evidence-based literature review completed by Cindy Syrovatka, MS, OTR/L, and Stacy Smallfield, DROT, MSOT, OTR/L, BCG, FAOTA, Faculty Advisor, University of South Dakota. 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 7