The HIIT-Home4Parkinson's Study

NCT ID: NCT05485428

Last Updated: 2024-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

13 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-05-01

Brief Summary

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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

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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.

Conditions

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Parkinson's Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Assessor blinded to group allocation

Study Groups

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Exercise

High-intensity interval training plus usual care

Group Type EXPERIMENTAL

High-intensity interval training

Intervention Type OTHER

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

Usual care

Usual care / treatment. Usual physical activity.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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High-intensity interval training

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Plymouth

OTHER

Sponsor Role lead

Responsible Party

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(Ivan) Conrad Harpham

PhD student, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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University Hospitals Plymouth NHS Trust

Plymouth, Devon, United Kingdom

Site Status

Countries

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United Kingdom

References

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Harpham C, Gunn H, Marsden J, Bescos-Garcia R, Murgatroyd C, Connolly L. Home-Based High-Intensity Interval Training for People With Parkinson's: A Randomized, Controlled, Feasibility Trial. Health Sci Rep. 2025 Jul 14;8(7):e71024. doi: 10.1002/hsr2.71024. eCollection 2025 Jul.

Reference Type DERIVED
PMID: 40661734 (View on PubMed)

Other Identifiers

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UPlymouthCH

Identifier Type: -

Identifier Source: org_study_id

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