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

NCT06192628 | Unknown

• 1 other identifier: 20114
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Parkinson Disease

Keywords

behavioural change intervention; exercise self-efficacy; exercise adherence; physiotherapy; theoretical domains framework

Outcome Measures

Primary Outcomes (5)

• Average daily step-count

  Accelerometry data measuring one week of walking

  week 0 and week 12

• Incidence of falls in the previous three months (self-reported)

  recorded falls and near falls events

  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

  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

  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.)

  week 0 and week 12

Secondary Outcomes (2)

• Exercise endurance

  week 0 and week 12

• Health related Quality of Life

  week 0 and week 12

Study Arms (2)

Parkinson's Education and Exercise Programme [PEEP]

ACTIVE COMPARATOR

12 week programme of exercises and educational sessions

Behavioral: Parkinson's Exercise and Education Programme

Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC]

EXPERIMENTAL

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

Interventions

Parkinson's Exercise and Education Programme BEHAVIORAL

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 [PEEP]

Parkinson's Exercise and Education Programme and Behavioural Change BEHAVIORAL

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.

Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC]

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University College Cork: lead

Study Sites (1)

St Marys Primary Care Centre

Cork, T12 X70A, Ireland

Location

Related Publications (2)

• 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.

  PMID: 40901341 DERIVED

• 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.

  PMID: 38784965 DERIVED

MeSH Terms

Conditions

Parkinson Disease

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Study Officials

• Ruth McCullagh, PhD

  University College Cork

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: patients are randomly allocated using concealed envelopes, and they are not informed as to which arm they have been allocated. They both receive an exercise programme, with the active arm receiving additional behavioral change techniques to promote exercise adherence and exercise self efficacy
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer in Physiotherapy

Model Details: two-arm single blinded randomised feasibility study

Study Record Dates

• First Submitted: December 19, 2023
• First Posted: January 5, 2024
• Study Start: September 10, 2023
• Primary Completion: January 31, 2024
• Study Completion: January 31, 2024
• Last Updated: January 5, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF
• Time Frame: June 2024, with no time limit
• Access Criteria: unknown as yet

Locations

IE (1)