An interventional study of Parkinson's Exercise and Education Programme and Parkinson's Exercise and Education Programme and Behavioural Change in Parkinson Disease, sponsored by University College Cork. Active, not recruiting at 1 site in Ireland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-05.
Sponsored by University College Cork · Not applicable, Interventional, and Treatment
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.
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.
4,487 studies on the registry are indexed under Parkinson Disease; 1,082 are open to participants now.
This study's planned enrollment of 20 is below the median of 40 across 3,294 interventional studies indexed under Parkinson Disease.
Browse Parkinson Disease studies →University College Cork is the lead sponsor of 116 studies on the registry; 23 are open to participants now.
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Exclusion Criteria:
A diagnosis of atypical Parkinson's (e.g., progressive supranuclear palsy, multiple system atrophy, etc) or vascular Parkinsonism or drug-induced parkinsonism
12 week programme of exercises and educational sessions
Behavioral: Parkinson's Exercise and Education Programme
12 week programme of exercise and education with additional behavioural change techniques to promote exercise adherence and exercise self-efficacy.
Behavioral: Parkinson's Exercise and Education Programme and Behavioural Change
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)
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.
Average daily step-count
Accelerometry data measuring one week of walking
Time frame: week 0 and week 12
Incidence of falls in the previous three months (self-reported)
recorded falls and near falls events
Time frame: week 0 and week 12
Timed Up and Go Test (Walking speed; metres per second)
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
Time frame: week 0 and week 12
Two Minute Free Walking Test (Walking Speed; metres per second)
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
Time frame: week 0 and week 12
Exercise Self-efficacy Scale
\[Self reported\] Exercise Self Efficacy Scale, validated in people with Parkinson's (score range 10-40, higher indicating more confidence.)
Time frame: week 0 and week 12
Exercise endurance
Six minute walk test
Time frame: week 0 and week 12
Health related Quality of Life
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.
Time frame: week 0 and week 12
Plan to share: Yes — We plan to share aggregated data and store anonymised data on an open repository linked to the published report of the study, with a unique digital object identifier (DOI).
Supporting information: Study protocol, Icf
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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University College Cork