Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Park… (NCT06192628) | Clinical Trial Compass
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Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's
Ireland20 participantsStarted 2023-09-10
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* • 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Average daily step-count
Timeframe: week 0 and week 12
2
Incidence of falls in the previous three months (self-reported)
Timeframe: week 0 and week 12
3
Timed Up and Go Test (Walking speed; metres per second)
Timeframe: week 0 and week 12
4
Two Minute Free Walking Test (Walking Speed; metres per second)