The HIIT-Home4Parkinson's Study
- Conditions
- Parkinson's Disease
- Interventions
- Other: High-intensity interval training
- Registration Number
- NCT05485428
- Lead Sponsor
- University of Plymouth
- Brief Summary
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).
- Detailed Description
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.
Participants will then undergo post-intervention outcome measures. Participants will also be asked to be involved in a 45-minute post intervention focus group as part of a process evaluation. Depending on numbers, it is likely that there will be 2 of these parallel groups.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 13
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Exercise High-intensity interval training High-intensity interval training plus usual care
- Primary Outcome Measures
Name Time Method Change from baseline brain derived neurotrophic factor (BDNF) 1 week before first exercise session and 1 day after last session. Blood sample: Brain-derived neurotrophic factor (pg/ml)
Programme completion Through study completion, an average of 12 weeks Number of weeks of exercise programme completed, self administered
Programme adherence Through study completion, an average of 12 weeks Number of exercise sessions completed in full, self administered
Change from baseline Relative VO2max 1 week before first exercise session and 1 day after last session. Maximal oxygen uptake (ml/min/kg) incremental exercise test
- Secondary Outcome Measures
Name Time Method 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. Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity
Adverse effects and events Through study completion, an average of 12 weeks Adverse effects and events related to exercise sessions, self administered
Oxford Participation Activities Questionnaire 1 week before first exercise session and 1 day after last session Participant administered lifestyle questionnaire
Exercise intensity Through study completion, an average of 12 weeks Achieved exercise intensity (% of maximum heart rate), self administered
Change from baseline 30 second sit to stand test 1 week before first exercise session and 1 day after last session. Number of times standing in 30 seconds
Trial Locations
- Locations (1)
University Hospitals Plymouth NHS Trust
🇬🇧Plymouth, Devon, United Kingdom