Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 13
- 试验地点
- 2
- 主要终点
- Programme completion
研究概览
简要总结
This project aims to investigate the practicality and utility of home-based high-intensity interval training (HIIT) by undertaking a previously developed, novel home-based HIIT intervention for people with Parkinson's (PwP).
详细描述
This is a randomised controlled feasibility study with mechanistic, physiological and clinical sub components.
Participants will be undertaking a 12-week home-based high-intensity interval training intervention. The programme is a feasibility study, previously co-created by people with Parkinson's and clinicians within an iterative planning process of focus groups and exercise testing.
Following recruitment, participants will undertake initial baseline assessments. These will involve collection of anthropometric measurements and general lifestyle and Parkinson's related information, followed by pre-intervention mechanistic, physiological and clinical outcome measures. Participants will then be randomised to the HIIT intervention, or usual care control group.
Both groups will then undertake 7 days pre-intervention physical activity monitoring following accelerometer instruction, as a baseline measure of habitual physical activity (an important confounding variable).
Following an initial home visit, participants will then undertake a 12-week high-intensity interval training programme in the home setting, with supplied exercise equipment including music and exercise prompts, and remote support and online resources. Participants will complete a 32 minute training session 3 times per week, with at least one day of rest between sessions. Participants will be loaned heart rate monitoring devices, which will remotely record heart rate per exercise session. During week 7 of the intervention, participants will be asked to repeat 7 days of accelerometer wearing to compare habitual physical activity. Participants will record feasibility and safety aspects such as HIIT participation / adverse effects and events / exercise adaptations in diaries during the course of the intervention.
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 (Outcomes Assessor)
盲法说明
Assessor blinded to group allocation
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Programme completion
时间窗: Through study completion, an average of 12 weeks
Number of weeks of exercise programme completed, self administered
Change from baseline brain derived neurotrophic factor (BDNF)
时间窗: 1 week before first exercise session and 1 day after last session.
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Programme adherence
时间窗: Through study completion, an average of 12 weeks
Number of exercise sessions completed in full, self administered
Change from baseline Relative VO2max
时间窗: 1 week before first exercise session and 1 day after last session.
Maximal oxygen uptake (ml/min/kg) incremental exercise test
次要结局
- Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3(1 week before first exercise session and 1 day after last session.)
- Oxford Participation Activities Questionnaire(1 week before first exercise session and 1 day after last session)
- Adverse effects and events(Through study completion, an average of 12 weeks)
- Exercise intensity(Through study completion, an average of 12 weeks)
- Change from baseline 30 second sit to stand test(1 week before first exercise session and 1 day after last session.)
研究者
(Ivan) Conrad Harpham
PhD student, Principal Investigator
University of Plymouth