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

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.