A Randomised Controlled Feasibility Study to Promote Physical Activity and Exercise Adherence Among People With Parkinson's
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Incidence of falls in the previous three months (self-reported)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
盲法说明
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
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •• 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.
研究组 & 干预措施
Parkinson's Education and Exercise Programme [PEEP]
12 week programme of exercises and educational sessions
干预措施: Parkinson's Exercise and Education Programme (Behavioral)
Parkinson's Education and Exercise Programme and Behavioural Change [PEEP-BC]
12 week programme of exercise and education with additional behavioural change techniques to promote exercise adherence and exercise self-efficacy.
干预措施: Parkinson's Exercise and Education Programme and Behavioural Change (Behavioral)
结局指标
主要结局
Incidence of falls in the previous three months (self-reported)
时间窗: week 0 and week 12
recorded falls and near falls events
Average daily step-count
时间窗: week 0 and week 12
Accelerometry data measuring one week of walking
Timed Up and Go Test (Walking speed; metres per second)
时间窗: 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)
时间窗: 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
时间窗: 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.)
次要结局
- Exercise endurance(week 0 and week 12)
- Health related Quality of Life(week 0 and week 12)
研究者
Ruth McCullagh
Lecturer in Physiotherapy
University College Cork