Parkinson DiseasePDActiveNCT06192628
Behavioural Change Techniques for Physical Activity and Exercise Adherence Among People With Parkinson's
A study testing Parkinson's Exercise and Education Programme and Parkinson's Exercise and Education Programme and Behavioural Change in people with Parkinson Disease, run by University College Cork at 1 site in Ireland.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson Disease
- What is being tested?
- Parkinson's Exercise and Education Programme and Parkinson's Exercise and Education Programme and Behavioural Change
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIreland
- Study dates
- 10 Sep 2023to 31 Jan 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- • 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People With Parkinson's
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.
Read more
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.
Read the 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.
- Conditions
- Parkinson Disease
- Being tested
- Parkinson's Exercise and Education Programme, Parkinson's Exercise and Education Programme and Behavioural Change
- Keywords
- behavioural change intervention, exercise self-efficacy, exercise adherence, physiotherapy, theoretical domains framework
- Medical subject headings
- Parkinson Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Parkinson's Exercise and Education ProgrammeBehavioural
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 ChangeBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Parkinson's Education and Exercise Programme [PEEP] | Active comparator | 12 week programme of exercises and educational sessions Receives: 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. Receives: Behavioral: Parkinson's Exercise and Education Programme and Behavioural Change |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average daily step-count
Accelerometry data measuring one week of walking
Measured: week 0 and week 12
Incidence of falls in the previous three months (self-reported)
recorded falls and near falls events
Measured: 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
Measured: 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
Measured: 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.)
Measured: week 0 and week 12
Secondary outcomes (2)
Exercise endurance
Six minute walk test
Measured: 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.
Measured: week 0 and week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2024
- Study start10 Sep 2023
- Primary completion31 Jan 2024 (estimated)
- Study completion31 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Parkinson DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two-arm single blinded randomised feasibility study
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University College Cork
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ruth McCullagh, University College Cork
- Investigators
- Ruth McCullagh, PhD, Principal investigator, University College Cork
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06192628
- Sponsor's protocol ID
- 20114
- Acronym
- PDActive
- Status last verified
- Jan 2024
- First submitted
- 19 Dec 2023
- Last updated
- 5 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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).
Publications
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.
PubMed 40901341Ahern 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.
PubMed 38784965
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People With Parkinson's
- ClinicalTrials.gov ID
- NCT06192628
- Acronym / sponsor ID
- PDActive / 20114
- Conditions
- Parkinson Disease
- Keywords
- behavioural change intervention, exercise self-efficacy, exercise adherence, physiotherapy, theoretical domains framework
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University College CorkUniversity, hospital or other
- Study start
- 10 Sep 2023 (actual)
- Primary completion
- 31 Jan 2024 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 5 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- two-arm single blinded randomised feasibility study
| Arm | Type | Receives |
|---|---|---|
| Parkinson's Education and Exercise Programme [PEEP] | Active comparator | Behavioral: Parkinson's Exercise and Education Programme12 week programme of exercises and educational sessions |
| Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC] | Experimental | Behavioral: Parkinson's Exercise and Education Programme and Behavioural Change12 week programme of exercise and education with additional behavioural change techniques to promote exercise adherence and exercise self-efficacy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- • A diagnosis of atypical Parkinson's (e.g., progressive supranuclear palsy, multiple system atrophy, etc) or vascular Parkinsonism or drug-induced parkinsonism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Parkinson's Exercise and Education ProgrammeA 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) | Behavioural | Parkinson's Education and Exercise Programme [PEEP] |
| Parkinson's Exercise and Education Programme and Behavioural ChangeA 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. | Behavioural | Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC] |
Primary outcome
Average daily step-count
Time frame: week 0 and week 12
Accelerometry data measuring one week of walking
Incidence of falls in the previous three months (self-reported)
Time frame: week 0 and week 12
recorded falls and near falls events
Timed Up and Go Test (Walking speed; metres per second)
Time frame: week 0 and week 12
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
Two Minute Free Walking Test (Walking Speed; metres per second)
Time frame: week 0 and week 12
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
Exercise Self-efficacy Scale
Time frame: week 0 and week 12
[Self reported] Exercise Self Efficacy Scale, validated in people with Parkinson's (score range 10-40, higher indicating more confidence.)
2 secondary outcomes
Exercise endurance
Time frame: week 0 and week 12
Health related Quality of Life
Time frame: week 0 and week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2024.
- Derived from this study: PubMed 40901341Ahern 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.
- Derived from this study: PubMed 38784965Ahern 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.
- Individual participant dataSharing planned: 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).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ruth McCullagh, PhD principal investigator
University College Cork
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Parkinson's Exercise and Education Programme and Parkinson's Exercise and Education Programme and Behavioural Change in people with Parkinson Disease, run by University College Cork at 1 site in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Average daily step-count (time frame: week 0 and week 12). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06192628, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2024.