Piloting a Home-based HIIT (High Intensity Interval Training) Intervention for People With Parkinson's

Sponsor

University of Plymouth (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05485428

Collaborator

(none)

Enrollment

Arms

Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

This project aims to investigate the practicality and utility of home-based high-intensity interval training (HIIT) by piloting a previously developed, novel home-based HIIT intervention for people with Parkinson's (PwP).

Condition or Disease	Intervention/Treatment	Phase
Parkinson's Disease	Other: High-intensity interval training	N/A

Detailed Description

Participants will be undertaking a 12-week home-based high-intensity interval training intervention. The programme is a pilot intervention, previously co-created by people with Parkinson's and clinicians within an iterative planning process of focus groups and exercise testing.

Participants will initially undertake 7 days pre-intervention, of accelerometer wearing (daytime only) following accelerometer instruction, as a baseline measure of habitual physical activity (an important confounding variable).

Following this, participants will undertake exercise programme instruction, and initial baseline assessments. These will involve collection of anthropometric measurements and general lifestyle and Parkinson's related information, followed by pre-intervention outcome measures.

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 30 minute training session 3 times per week, with at least one day of rest between sessions. Participants will also complete a self-administered outcome measure every 2 weeks. 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 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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

24 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Pilot study with possible randomised exercise / control group allocation (depending on number of participants recruited). It is possible that it will be a single group design.Pilot study with possible randomised exercise / control group allocation (depending on number of participants recruited). It is possible that it will be a single group design.

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Piloting a Home-based High-intensity Interval Training Programme for People With Parkinson's: The HIIT-Home4Parkinson's Study

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Aug 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Exercise High-intensity exercise	Other: High-intensity interval training 12-weeks of high intensity interval exercise, 30 minutes thrice weekly
No Intervention: Usual care Usual care / treatment. Usual physical activity.

Arm

Intervention/Treatment

Experimental: Exercise

High-intensity exercise

Other: High-intensity interval training

12-weeks of high intensity interval exercise, 30 minutes thrice weekly

No Intervention: Usual care

Usual care / treatment. Usual physical activity.

Outcome Measures

Primary Outcome Measures

Change from baseline Relative VO2max [1 day before first exercise session and 1 day after last session.]
Maximal oxygen uptake (ml/min/kg) incremental exercise test
Change from baseline brain derived neurotrophic factor (BDNF) [1 day before first exercise session and 1 day after last session.]
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3 [1 day before first exercise session and 1 day after last session.]
Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity
Programme completion [Through study completion, an average of 12 weeks]
Number of weeks of exercise programme completed, self administered

Secondary Outcome Measures

Programme adherence [Through study completion, an average of 12 weeks]
Number of exercise sessions completed in full, self administered
Exercise intensity [Through study completion, an average of 12 weeks]
Achieved exercise intensity (% of maximum heart rate), self administered
Adverse effects and events [Through study completion, an average of 12 weeks]
Adverse effects and events related to exercise sessions, self administered
Change from baseline 30 second sit to stand test [1 day before first exercise session and 1 day after last session.]
Number of times standing in 30 seconds

Other Outcome Measures

Total weekly habitual physical activity [1 week prior to start of programme]
Weekly physical activity (minutes) measured with accelerometer, self administered
Total weekly habitual physical activity [During week 7 of programme]
Weekly physical activity (minutes) measured with accelerometer, self administered
Maximum heart rate [1 day before first exercise session]
Beats per minute, to be measured during VO2max assessment
Height [1 day before first exercise session]
Height (centimetres) with stadiometer
Weight [1 day before first exercise session]
Weight (kilograms) with calibrated digital scales
Lifestyle data questionnaire [1 day before first exercise session]
10-item basic lifestyle data bespoke questionnaire
30 second sit to stand test [2 weeks after first exercise session]
Number of times standing in 30 seconds, self administered
30 second sit to stand test [4 weeks after first exercise session]
Number of times standing in 30 seconds, self administered
30 second sit to stand test [6 weeks after first exercise session]
Number of times standing in 30 seconds, self administered
30 second sit to stand test [8 weeks after first exercise session]
Number of times standing in 30 seconds, self administered
30 second sit to stand test [10 weeks after first exercise session]
Number of times standing in 30 seconds, self administered

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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