Clinical trial NCT05485428: The HIIT-Home4Parkinson's Study
Official title: Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson's Disease
Keywords: HIIT
Exercise
Neurodegenerative
Physical
High-intensity
Interval
Home-based
Training
Lead sponsor: University of Plymouth
Sponsor class: OTHER
First posted: 2022-08-03
Enrollment: 13
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Programme completion
timeFrame: Through study completion, an average of 12 weeks
measure: Programme adherence
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline brain derived neurotrophic factor (BDNF)
timeFrame: 1 week before first exercise session and 1 day after last session.
measure: Change from baseline Relative VO2max
timeFrame: 1 week before first exercise session and 1 day after last session.
Secondary outcomes:
measure: Adverse effects and events
timeFrame: Through study completion, an average of 12 weeks
measure: Change from baseline 30 second sit to stand test
timeFrame: 1 week before first exercise session and 1 day after last session.
measure: Oxford Participation Activities Questionnaire
timeFrame: 1 week before first exercise session and 1 day after last session
measure: Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3
timeFrame: 1 week before first exercise session and 1 day after last session.
measure: Exercise intensity
timeFrame: Through study completion, an average of 12 weeks
Other outcomes:
measure: Total weekly habitual physical activity
timeFrame: 1 week prior to start of exercise programme after baseline assessments
measure: Total weekly habitual physical activity
timeFrame: During week 7 of the exercise programme
measure: Maximum heart rate
timeFrame: 1 week before first exercise session
measure: Height
timeFrame: 1 week before first exercise session
measure: Weight
timeFrame: 1 week before first exercise session
measure: Lifestyle data questionnaire
timeFrame: 1 week before first exercise session
measure: Health screening questionnaire
timeFrame: 1 week before first exercise session at baseline assessments
Locations:
city: Plymouth
country: United Kingdom
facility: University Hospitals Plymouth NHS Trust
state: Devon
Study officials:
References: