The HIIT-Home4Parkinson's Study

Study Overview
=================
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.

Official Title
-----------------
Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study

Conditions
-----------------
Parkinson's Disease

Intervention / Treatment
-----------------
* Other: High-intensity interval training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Diagnosed with Parkinson's disease Aged 18 years or older (No upper limit) Hoehn and Yahr stages 1-3 (Mild to moderate disease severity) Capacity to consent under the Mental Capacity Act 2005, and able to follow an exercise programme Based at home with enough space to perform an exercise programme Willing and able to travel to intervention assessments Access to a computer, Smart Phone, or tablet and to the internet. Exclusion criteria: Other concurrent neurological condition Co-morbidities that would prevent / be exacerbated by high-intensity exercise such as forms of cardiovascular disease Advised to not participate following medical consultation Participation in a contemporaneous interventional study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise<br>High-intensity interval training plus usual care | Other: High-intensity interval training<br>* 12-weeks of high intensity interval exercise, 30 minutes thrice weekly<br>|
| No Intervention: Usual care<br>Usual care / treatment. Usual physical activity. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Programme completion | Number of weeks of exercise programme completed, self administered | Through study completion, an average of 12 weeks | 
| Programme adherence | Number of exercise sessions completed in full, self administered | Through study completion, an average of 12 weeks | 
| Change from baseline brain derived neurotrophic factor (BDNF) | Blood sample: Brain-derived neurotrophic factor (pg/ml) | 1 week before first exercise session and 1 day after last session. | 
| Change from baseline Relative VO2max | Maximal oxygen uptake (ml/min/kg) incremental exercise test | 1 week before first exercise session and 1 day after last session. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects and events | Adverse effects and events related to exercise sessions, self administered | Through study completion, an average of 12 weeks | 
| Change from baseline 30 second sit to stand test | Number of times standing in 30 seconds | 1 week before first exercise session and 1 day after last session. | 
| Oxford Participation Activities Questionnaire | Participant administered lifestyle questionnaire | 1 week before first exercise session and 1 day after last session | 
| Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3 | Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity | 1 week before first exercise session and 1 day after last session. | 
| Exercise intensity | Achieved exercise intensity (% of maximum heart rate), self administered | Through study completion, an average of 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIIT, Exercise, Neurodegenerative, Physical, High-intensity, Interval, Home-based, Training