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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
University of Plymouth
About
Eligibility
Locations
Arms
Outcomes
Full info

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

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

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

    First Posted
    July 27, 2022
    Last Updated
    May 3, 2023
    Sponsor
    University of Plymouth
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    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

    Learn more about this trial

    The HIIT-Home4Parkinson's Study

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