Dementia Moves: protocol for a feasibility study testing a physical rehabilitation program for long-term care residents with moderate to severe dementia.
Caitlin McArthur, Niousha Alizadehsaravi, Rebecca Affoo, Karen Cooke, Natalie F Douglas, Marie Earl, Melanie K Farlie, Trudy Flynn, Parisa Ghanouni, Susan W Hunter, Shannan M Grant, Laura E Middleton, Elaine Moody, Cheryl Smith, Linda Verlinden, Lori E Weeks
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引用次数: 0
Abstract
Background: Most long-term care (LTC) residents live with dementia and the proportion with more advanced cognitive impairment is increasing. Residents with dementia often have limited functional ability to complete their activities of daily living (ADLs) and are vulnerable to further functional decline. Multicomponent exercise can help prevent functional decline, but residents with dementia are less likely to receive it and have not often been included in previous intervention studies. The Dementia Moves intervention was designed to fill this gap. It is an individually tailored multicomponent group exercise program with an aerobic warm-up and a focus on moderate to high-intensity functional balance and strength training. We will measure the feasibility and effect of the Dementia Moves program on ADLs for LTC residents with moderate to severe dementia (Mini-Mental State Exam of 20 or less). We hypothesize the intervention will be feasible without modification if 16 individuals are recruited over 6 months, 65% of our sample is retained at 6 months and 75% of the completed exercises are performed at a moderate to high intensity.
Methods: A pre-post study will be used to assess feasibility, safety (rates of falls and adverse events extracted from the electronic medical record), and change in ADLs at 3 and 6 months among LTC residents with moderate to severe dementia. There will be no control or comparison group. A physiotherapist, physiotherapy assistant and three volunteers will deliver the group-based exercise program to groups of four residents, three times per week, for 6 months. Assessments will be completed at 3 and 6 months. Feasibility outcomes include (1) recruitment over 6 months; (2) retention at 3- and 6-month follow-up; and adherence via (3) attendance and (4) proxy and self-reported ratings of exercise intensity. We will also assess fidelity of the intervention through program audits, and audio diaries and interviews to identify barriers and facilitators to implementation of the intervention.
Discussion: The feasibility of the Dementia Moves intervention will be evaluated in LTC residents with dementia, and we will examine rates of falls and adverse events and change in ADLs. We will use the collected information to inform a definitive parallel cluster randomized controlled trial.
Trial registration:
Clinicaltrials: gov: NCT06400108, May 3, 2024, Version 1. https://classic.
期刊介绍：
Pilot and Feasibility Studies encompasses all aspects of the design, conduct and reporting of pilot and feasibility studies in biomedicine. The journal publishes research articles that are intended to directly influence future clinical trials or large scale observational studies, as well as protocols, commentaries and methodology articles. The journal also ensures that the results of all well-conducted, peer-reviewed, pilot and feasibility studies are published, regardless of outcome or significance of findings. Pilot and feasibility studies are increasingly conducted prior to a full randomized controlled trial. However, these studies often lack clear objectives, many remain unpublished, and there is confusion over the meanings of the words “pilot” and “feasibility”. Pilot and Feasibility Studies provides a forum for discussion around this key aspect of the scientific process, and seeks to ensure that these studies are published, so as to complete the publication thread for clinical research.
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