Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's

Parkinson Disease Clinical Trial

— PDActive  

Official title:

A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People With Parkinson's

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06192628
• Other study ID #: 20114
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 10, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: January 2024
• Source: University College Cork
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: January 31, 2024
• Est. primary completion date: January 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Parkinson Disease

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Ireland	St Marys Primary Care Centre	Cork

Sponsors (1)

Lead Sponsor	Collaborator
University College Cork

Country where clinical trial is conducted

Ireland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Average daily step-count	Accelerometry data measuring one week of walking	week 0 and week 12
Primary	Incidence of falls in the previous three months (self-reported)	recorded falls and near falls events	week 0 and week 12
Primary	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	week 0 and week 12
Primary	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	week 0 and week 12
Primary	Exercise Self-efficacy Scale	[Self reported] Exercise Self Efficacy Scale, validated in people with Parkinson's (score range 10-40, higher indicating more confidence.)	week 0 and week 12
Secondary	Exercise endurance	Six minute walk test	week 0 and week 12
Secondary	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.	week 0 and week 12