Extended data for behavioural change for Parkinson’s disease: A randomised controlled feasibility study to promote physical activity and exercise adherence among people with Parkinson’s, study protocol
Data files
Jan 04, 2024 version files 237.61 KB
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Extended_Data_Leanne_Ahern.docx
236.18 KB
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README.md
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Abstract
Background: Parkinson’s is a common progressive neurological condition characterized by motor and non-motor deficits. Physical activity and exercise can improve health, but many people with Parkinson’s have trouble reaching the recommended dosage. Our recent literature review found improvements in exercise adherence with behavioural change interventions, but it remains unclear which are most effective. Further qualitative research and patient and public involvement has informed a novel behavioural change support intervention to be tested alongside an existing exercise program.
Objective: To examine the feasibility of behavioural change support techniques delivered alongside an exercise programme to improve physical activity, function, and self-efficacy in PwP (and study procedures) to inform a future pilot RCT trial.
Methods: A parallel-arm single blinded randomised feasibility study. Twenty participants with Parkinson’s (Hoehn and Yahr stage 1-3) will be recruited from a physiotherapy primary-care waiting list. Following written consent, and baseline assessment, the participants will be randomly allocated to the intervention (n=10) or the control group (n=10). Both groups will receive usual care, which includes a weekly program of a multidisciplinary education, a supervised exercise class and a prescribed home exercise program. The intervention group will receive additional behavioural change techniques, targeting behaviour regulation, belief about capabilities and social influences. Class and home exercise adherence, behavioural component uptake and adherence, and negative events will be recorded. Outcomes will include enrolment and maintenance rates, physical function, falls, physical activity, and exercise self-efficacy measured pre- and post- the 12- week program (in-person). Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques.
Discussion: The results will help inform a future pilot RCT, based on the intervention acceptability, consent rate, maintenance, and protocol integrity.
README: Extended Data Feasibility study Protocol
https://doi.org/10.5061/dryad.prr4xgxt5
Description of the data and file structure
- Exercise Diary: participants are required to complete the exercise activity as a method of tracking their physical activity. They will be required to complete it each night for 12 weeks. Information includes the type of exercise, duration, location, whether it was perform alone/with a partner/in a group, how difficulty they how it, how they felt afterwards, reasons for not exercising.
- Behavioural Change template: this template will be completed by the researcher each week. At the beginning of the exercise class each week the researcher and the participant with have a 1:1 discussion to complete the template. This is the master template, questions will be asked frequently, not all questions will be asked each week to avoid repetition.
- Feedback survey: this will be given to all participants (intervention and usual care group) on week 11 to complete, they can express their views on what they likes and disliked in the program, they can also offer suggestions.
- Topic guide: for the 1:1 online interviews with the participants in the intervention group only to obtain their opinions on the behavioural change techniques employed.
Sharing/Access information
The data sets used and analysed during this study are available from the corresponding authors on request.
Methods
Surveys will be used to compare experiences and satisfaction between groups. Exit interviews will be completed with the intervention group only, exploring their experience of the behavioural change techniques.