Abstract
BACKGROUND: People living with dementia (PLwD) have a high fall risk as cognitive impairment compromises control of gait and balance. Fall prevention exercises that are effective in healthy older adults may not work for PLwD. Cognitive stimulation therapy (CST) has been shown to improve global cognition in PLwD. A programme which combines cognitive (CST) with physical exercises may reduce falls in PLwD. The aim of this study was to assess the feasibility of undertaking a full scale randomised controlled trial to test the effectiveness of CogEx in decreasing falls in PLwD. Specific objectives included recruitment strategy, data collection, outcome measures, intervention fidelity and facilitator/participant experience. METHODS: A mixed methods feasibility randomised controlled trial recruited people from residential aged care. Inclusion criteria were ≥ 65 years old, Montreal Cognitive Assessment (MoCA) score of 10 to 26 and able to participate in a group. Participants were randomised to CST or CST combined with strength and balance exercises (CogEx). Both CST and CogEx groups were for an hour twice a week for 7 weeks. Descriptive statistics were used to report pre- and post-intervention outcome measures (MoCA, Geriatric Depression Scale-15, Quality of Life-Alzheimer's Disease, Alzheimer's Disease Assessment Scale-Cognitive 11, Brief Balance Evaluation Systems Test and Short Form Physical Performance Battery) and attendance. Qualitative analysis of participant focus groups and facilitator interviews used a conventional approach. Sessions were video recorded and exercise completion documented. RESULTS: Thirty-six residents were screened with 23 participants randomised to intervention (CogEx, n = 10) or control (CST, n = 13). The assessments took 45 min to 1.5 h, and there was repetition between two cognitive measures. Ten facilitators completed training with the manualised programme. Exercises were combined into the hour-long CST session; however, limited balance training occurred with participants exercising predominantly in sitting. The facilitators felt the participants engaged more and were safer in sitting. CONCLUSIONS: The results demonstrated that while fall prevention exercises could be scheduled into the CST structure, the fidelity of the combined programme was poor. Other components of the study design need further consideration before evaluation using a randomised controlled trial is feasible. TRIAL REGISTRATION: anzctr.org.au (ACTRN12616000751471) 8 Jun 2016, Australian New Zealand Clinical Trials Registry.