The HIIT-Home4Parkinson's Study (HH4P)
Primary Purpose
Parkinson's Disease
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
High-intensity interval training
Sponsored by
About this trial
This is an interventional treatment trial for Parkinson's Disease focused on measuring HIIT, Exercise, Neurodegenerative, Physical, High-intensity, Interval, Home-based, Training
Eligibility Criteria
Inclusion Criteria:
- Diagnosed with Parkinson's disease
- Hoehn and Yahr stages 1-3
- No other pre-existing health conditions that would prevent / be exacerbated by high-intensity exercise
- Sufficient cognitive ability to follow an exercise programme and to provide informed consent
- Internet access
Exclusion Criteria:
- Other forms of Parkinsonism or neurological condition
- Hoehn and Yahr stages 4 and 5
- Other pre-existing health conditions that would prevent / be exacerbated by high-intensity exercise
- Insufficient cognitive ability to follow an exercise programme or provide informed consent
- No Internet access
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Usual care
Arm Description
High-intensity interval training plus usual care
Usual care / treatment. Usual physical activity.
Outcomes
Primary Outcome Measures
Programme completion
Number of weeks of exercise programme completed, self administered
Programme adherence
Number of exercise sessions completed in full, self administered
Change from baseline brain derived neurotrophic factor (BDNF)
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Change from baseline Relative VO2max
Maximal oxygen uptake (ml/min/kg) incremental exercise test
Secondary Outcome Measures
Adverse effects and events
Adverse effects and events related to exercise sessions, self administered
Change from baseline 30 second sit to stand test
Number of times standing in 30 seconds
Oxford Participation Activities Questionnaire
Participant administered lifestyle questionnaire
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
Exercise intensity
Achieved exercise intensity (% of maximum heart rate), self administered
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05485428
Brief Title
The HIIT-Home4Parkinson's Study
Acronym
HH4P
Official Title
Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2023 (Anticipated)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
May 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Plymouth
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Parkinson's Disease
Keywords
HIIT, Exercise, Neurodegenerative, Physical, High-intensity, Interval, Home-based, Training
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
Masking
Outcomes Assessor
Masking Description
Assessor blinded to group allocation
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
High-intensity interval training plus usual care
Arm Title
Usual care
Arm Type
No Intervention
Arm Description
Usual care / treatment. Usual physical activity.
Intervention Type
Other
Intervention Name(s)
High-intensity interval training
Intervention Description
12-weeks of high intensity interval exercise, 30 minutes thrice weekly
Primary Outcome Measure Information:
Title
Programme completion
Description
Number of weeks of exercise programme completed, self administered
Time Frame
Through study completion, an average of 12 weeks
Title
Programme adherence
Description
Number of exercise sessions completed in full, self administered
Time Frame
Through study completion, an average of 12 weeks
Title
Change from baseline brain derived neurotrophic factor (BDNF)
Description
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Time Frame
1 week before first exercise session and 1 day after last session.
Title
Change from baseline Relative VO2max
Description
Maximal oxygen uptake (ml/min/kg) incremental exercise test
Time Frame
1 week before first exercise session and 1 day after last session.
Secondary Outcome Measure Information:
Title
Adverse effects and events
Description
Adverse effects and events related to exercise sessions, self administered
Time Frame
Through study completion, an average of 12 weeks
Title
Change from baseline 30 second sit to stand test
Description
Number of times standing in 30 seconds
Time Frame
1 week before first exercise session and 1 day after last session.
Title
Oxford Participation Activities Questionnaire
Description
Participant administered lifestyle questionnaire
Time Frame
1 week before first exercise session and 1 day after last session
Title
Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3
Description
Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity
Time Frame
1 week before first exercise session and 1 day after last session.
Title
Exercise intensity
Description
Achieved exercise intensity (% of maximum heart rate), self administered
Time Frame
Through study completion, an average of 12 weeks
Other Pre-specified Outcome Measures:
Title
Total weekly habitual physical activity
Description
Weekly physical activity (minutes) measured with accelerometer, self administered
Time Frame
1 week prior to start of exercise programme after baseline assessments
Title
Total weekly habitual physical activity
Description
Weekly physical activity (minutes) measured with accelerometer, self administered
Time Frame
During week 7 of the exercise programme
Title
Maximum heart rate
Description
Beats per minute, to be measured during VO2max assessment
Time Frame
1 week before first exercise session
Title
Height
Description
Height (centimetres) with stadiometer
Time Frame
1 week before first exercise session
Title
Weight
Description
Weight (kilograms) with calibrated digital scales
Time Frame
1 week before first exercise session
Title
Lifestyle data questionnaire
Description
10-item basic lifestyle data bespoke questionnaire
Time Frame
1 week before first exercise session
Title
Health screening questionnaire
Description
Screening for health issues that may prevent participation
Time Frame
1 week before first exercise session at baseline assessments
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ivan C Harpham, MSc
Phone
(+44) 1752 588800
Email
conrad.harpham@plymouth.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Luke Connolly, PhD
Phone
(+44) 1752 588800
Email
luke.connolly@plymouth.ac.uk
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
De-identified data will be available for a period of 10 years in line with University of Plymouth policy
IPD Sharing Access Criteria
On request
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The HIIT-Home4Parkinson's Study
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