Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's
- Conditions
- Parkinson Disease
- Interventions
- Behavioral: Parkinson's Exercise and Education Programme and Behavioural ChangeBehavioral: Parkinson's Exercise and Education Programme
- Registration Number
- NCT06192628
- Lead Sponsor
- University College Cork
- Brief Summary
Many people with Parkinson's (PwP) experience many barriers to reaching the recommended dosage of exercise. The aim of this study is to examine the feasibility of behavioural change support techniques delivered alongside an exercise programme to improve physical activity, function, to inform a future pilot randomised controlled trial.
Twenty participants with Parkinson's will be 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 to help them adhere to the exercises, targeting behaviour regulation, belief about capabilities and social influences.
Outcomes will measure how well people were able to stay in the programme, and their physical function after the 12 week programme. 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 randomised controlled trial, based on the intervention acceptability, consent rate, maintenance, and protocol integrity.
- Detailed 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 (PwP) 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 20
- Diagnosis of idiopathic Parkinson's Disease (Early Stages of Parkinson's H&Y Stage 1-3)
- Ability to drive or obtain transport that will drop and collect at the health centre.
- Ability to independently walk (with or without a walking aid)
- Reported by the referring healthcare provider or carer as able to follow instructions and carry out the exercise program independently at home.
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• A diagnosis of atypical Parkinson's (e.g., progressive supranuclear palsy, multiple system atrophy, etc) or vascular Parkinsonism or drug-induced parkinsonism
- Previously completed the PEEP program.
- Had a hospital admission < 6 weeks ago.
- Immobility, or are a wheelchair-user.
- Severe visual or auditory impairment
- Serious medical conditions in major organs (heart, lung, or kidney) or other illnesses which prevent independent ambulation or safe exercise.
- Been identified as a high falls risk (identified during the pre-screening using objective measure the Short Physical Performance Battery (a score of ≤6 indicates a higher fall risk in old adults27) and subjective reporting of frequent falls in the past six months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC] Parkinson's Exercise and Education Programme and Behavioural Change 12 week programme of exercise and education with additional behavioural change techniques to promote exercise adherence and exercise self-efficacy. Parkinson's Education and Exercise Programme [PEEP] Parkinson's Exercise and Education Programme 12 week programme of exercises and educational sessions
- Primary Outcome Measures
Name Time Method Incidence of falls in the previous three months (self-reported) week 0 and week 12 recorded falls and near falls events
Average daily step-count week 0 and week 12 Accelerometry data measuring one week of walking
Timed Up and Go Test (Walking speed; metres per second) week 0 and week 12 APDM Mobility Lab sensor-based gait and balance analysis system to objectively measure Timed Up and Go test and a 2-minute free walking test
Two Minute Free Walking Test (Walking Speed; metres per second) week 0 and week 12 APDM Mobility Lab sensor-based gait and balance analysis system to objectively measure Timed Up and Go test and a 2-minute free walking test
Exercise Self-efficacy Scale week 0 and week 12 \[Self reported\] Exercise Self Efficacy Scale, validated in people with Parkinson's (score range 10-40, higher indicating more confidence.)
- Secondary Outcome Measures
Name Time Method Exercise endurance week 0 and week 12 Six minute walk test
Health related Quality of Life week 0 and week 12 Parkinson's Disease Questionnaire-39 (PDQ-39). The scale contains 39 items covering eight dimensions of health status. Possible scores range between 0-100, with lower scores reflect better quality of life.
Trial Locations
- Locations (1)
St Marys Primary Care Centre
🇮🇪Cork, Ireland