Clinical trial NCT06192628: Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's
Official title: A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People With Parkinson's
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Parkinson Disease
Keywords: behavioural change intervention
exercise self-efficacy
exercise adherence
physiotherapy
theoretical domains framework
Lead sponsor: University College Cork
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two-arm single blinded randomised feasibility study
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Average daily step-count
timeFrame: week 0 and week 12
measure: Incidence of falls in the previous three months (self-reported)
timeFrame: week 0 and week 12
measure: Timed Up and Go Test (Walking speed; metres per second)
timeFrame: week 0 and week 12
measure: Two Minute Free Walking Test (Walking Speed; metres per second)
timeFrame: week 0 and week 12
measure: Exercise Self-efficacy Scale
timeFrame: week 0 and week 12
Secondary outcomes:
measure: Exercise endurance
timeFrame: week 0 and week 12
measure: Health related Quality of Life
timeFrame: week 0 and week 12
Other outcomes:
Locations:
city: Cork
country: Ireland
facility: St Marys Primary Care Centre
Study officials:
affiliation: University College Cork
name: Ruth McCullagh, PhD
role: PRINCIPAL_INVESTIGATOR
References: