Parkinson Disease
Conditions
Keywords
behavioural change intervention, exercise self-efficacy, exercise adherence, physiotherapy, theoretical domains framework
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.
Interventions
BEHAVIORALParkinson'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)
BEHAVIORALParkinson'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.
Sponsors
University College Cork
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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
Intervention model description
two-arm single blinded randomised feasibility study
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of falls in the previous three months (self-reported) | week 0 and week 12 | recorded falls and near falls events |
| Two Minute Free Walking Test (Walking Speed; metres per second) | 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 | 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.) |
| Average daily step-count | week 0 and week 12 | Accelerometry data measuring one week of walking |
| Timed Up and Go Test (Walking speed; metres per second) | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Exercise endurance | week 0 and week 12 | Six minute walk test |
| Health related Quality of Life | week 0 and week 12 | 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. |
Countries
Ireland
Outcome results
None listed