DOI: 10.5061/dryad.prr4xgxt5
title: 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

description: 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.
description: 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.  
description: # Extended Data Feasibility study Protocol
 ## Description of the data
 and file structure 1. 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. 2. 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. 3. 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. 4. 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.