Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's
NCT ID: NCT06192628
Last Updated: 2024-01-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
20 participants
INTERVENTIONAL
2023-09-10
2024-01-31
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Parkinson's Education and Exercise Programme [PEEP]
12 week programme of exercises and educational sessions
Parkinson's Exercise and Education Programme
A 12 week programme of exercise and education
The weekly programme consists of a 45-minute exercise programme, 45-minute education sessions delivered by healthcare professionals about their role in Parkinson's management, and independent home exercise programmes completed twice weekly (determined by the registered physiotherapist only)
Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC]
12 week programme of exercise and education with additional behavioural change techniques to promote exercise adherence and exercise self-efficacy.
Parkinson's Exercise and Education Programme and Behavioural Change
A 12-week programme of exercise, education and behavioural change techniques to support exercise adherence and exercise self-efficacy
The weekly programme consists of a 45-minute exercise programme, 45-minute education sessions delivered by healthcare professionals about their role in Parkinson's management, and independent home exercise programmes completed twice weekly (determined by the registered physiotherapist and participant)
Additional techniques addressing behavioural regulation include firstly, an exercise diary completed independently at home, secondly, the rationale and the intended functional benefit and expectations of the exercise programme clearly explained, thirdly individual weekly conversations to reflect on progress, expectations, solutions to barriers, and goals. Finally, peer support is strongly encouraged through the in-class support, and a social media networking group.
Interventions
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Parkinson's Exercise and Education Programme
A 12 week programme of exercise and education
The weekly programme consists of a 45-minute exercise programme, 45-minute education sessions delivered by healthcare professionals about their role in Parkinson's management, and independent home exercise programmes completed twice weekly (determined by the registered physiotherapist only)
Parkinson's Exercise and Education Programme and Behavioural Change
A 12-week programme of exercise, education and behavioural change techniques to support exercise adherence and exercise self-efficacy
The weekly programme consists of a 45-minute exercise programme, 45-minute education sessions delivered by healthcare professionals about their role in Parkinson's management, and independent home exercise programmes completed twice weekly (determined by the registered physiotherapist and participant)
Additional techniques addressing behavioural regulation include firstly, an exercise diary completed independently at home, secondly, the rationale and the intended functional benefit and expectations of the exercise programme clearly explained, thirdly individual weekly conversations to reflect on progress, expectations, solutions to barriers, and goals. Finally, peer support is strongly encouraged through the in-class support, and a social media networking group.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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University College Cork
OTHER
Responsible Party
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Ruth McCullagh
Lecturer in Physiotherapy
Principal Investigators
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Ruth McCullagh, PhD
Role: PRINCIPAL_INVESTIGATOR
University College Cork
Locations
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St Marys Primary Care Centre
Cork, , Ireland
Countries
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References
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Ahern L, Timmons S, Lamb SE, McCullagh R. Behaviour Change for Parkinson's Disease: A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People with Parkinson's Disease. J Frailty Sarcopenia Falls. 2025 Sep 1;10(3):128-149. doi: 10.22540/JFSF-10-128. eCollection 2025 Sep.
Ahern L, Timmons S, Lamb SE, McCullagh R. 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. HRB Open Res. 2024 May 29;7:7. doi: 10.12688/hrbopenres.13843.2. eCollection 2024.
Other Identifiers
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20114
Identifier Type: -
Identifier Source: org_study_id
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