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Completed

NCT Number: NCT05485428

The HIIT-Home4Parkinson's Study

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL68DH, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High-intensity interval training

Other

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

Primary outcomes

  1. Programme completion

    Time frame: Through study completion, an average of 12 weeks

    Number of weeks of exercise programme completed, self administered

  2. Programme adherence

    Time frame: Through study completion, an average of 12 weeks

    Number of exercise sessions completed in full, self administered

  3. Change from baseline brain derived neurotrophic factor (BDNF)

    Time frame: 1 week before first exercise session and 1 day after last session.

    Blood sample: Brain-derived neurotrophic factor (pg/ml)

  4. Change from baseline Relative VO2max

    Time frame: 1 week before first exercise session and 1 day after last session.

    Maximal oxygen uptake (ml/min/kg) incremental exercise test

Secondary outcomes

  1. Adverse effects and events

    Time frame: Through study completion, an average of 12 weeks

    Adverse effects and events related to exercise sessions, self administered

  2. Change from baseline 30 second sit to stand test

    Time frame: 1 week before first exercise session and 1 day after last session.

    Number of times standing in 30 seconds

  3. Oxford Participation Activities Questionnaire

    Time frame: 1 week before first exercise session and 1 day after last session

    Participant administered lifestyle questionnaire

  4. Change from baseline Movement Disorder Society Unified Parkinson's Disease Rating Scale part 3

    Time frame: 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

  5. Exercise intensity

    Time frame: Through study completion, an average of 12 weeks

    Achieved exercise intensity (% of maximum heart rate), self administered

Other outcomes

  1. Total weekly habitual physical activity

    Time frame: 1 week prior to start of exercise programme after baseline assessments

    Weekly physical activity (minutes) measured with accelerometer, self administered

  2. Total weekly habitual physical activity

    Time frame: During week 7 of the exercise programme

    Weekly physical activity (minutes) measured with accelerometer, self administered

  3. Maximum heart rate

    Time frame: 1 week before first exercise session

    Beats per minute, to be measured during VO2max assessment

  4. Height

    Time frame: 1 week before first exercise session

    Height (centimetres) with stadiometer

  5. Weight

    Time frame: 1 week before first exercise session

    Weight (kilograms) with calibrated digital scales

  6. Lifestyle data questionnaire

    Time frame: 1 week before first exercise session

    10-item basic lifestyle data bespoke questionnaire

  7. Health screening questionnaire

    Time frame: 1 week before first exercise session at baseline assessments

    Screening for health issues that may prevent participation

Sponsors and collaborators

Lead sponsor

University of Plymouth

Other

Registry information

Official study title

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

Acronym: HH4P

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Aug 3, 2022
Registry last updated
May 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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