Pilot randomized controlled trial of the ReFresh online fatigue management programme for people with Parkinson’s disease

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Abstract
Fatigue is one of the most disabling symptoms experienced by people with Parkinson's disease, yet few evidence-based non-pharmacological interventions are available. This study evaluated the feasibility, acceptability, and exploratory clinical signals of the Rebalancing Fatigue and Enhancing Self-Help (ReFresh) online fatigue management programme for people with Parkinson's disease. A pilot randomized controlled trial with a wait-list control group was conducted. Participants with Parkinson's disease experiencing fatigue were randomized to either the six-week ReFresh online programme or a wait-list control. Feasibility outcomes included recruitment, retention, adherence, and participant engagement. Secondary outcomes included fatigue severity, fatigue self-efficacy, sleep quality, mood, and occupational performance. A total of 118 participants were randomized. Recruitment targets were achieved; however, retention and adherence were modest. Participants who completed the programme reported improvements in fatigue self-efficacy and perceived ability to manage fatigue, while changes in fatigue severity were smaller. Qualitative feedback indicated that participants valued the flexibility and accessibility of the online format. The ReFresh programme demonstrated feasibility and acceptability as a digitally delivered fatigue management intervention for people with Parkinson's disease. Future research should explore strategies to improve engagement and evaluate the programme in a fully powered randomized controlled trial. ISRCTN Registry, ISRCTN62114944, https://www.isrctn.com/ISRCTN62114944.
Funding Information
  • King Saud University
  • National Institute for Health and Care Research (NIHR) Applied Research Collaboration East of England (NIHR ARC EoE) at Cambridge and Peterborough NHS Foundation Trust

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