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The HIIT-Home4Parkinson's Study (HH4P)

U

University of Plymouth

Status

Completed

Conditions

Parkinson's Disease

Treatments

Other: High-intensity interval training

Study type

Interventional

Funder types

Other

Identifiers

NCT05485428
UPlymouthCH

Details and patient eligibility

About

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).

Full 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.

Enrollment

13 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

13 participants in 2 patient groups

Exercise
Experimental group
Description:
High-intensity interval training plus usual care
Treatment:
Other: High-intensity interval training
Usual care
No Intervention group
Description:
Usual care / treatment. Usual physical activity.

Trial contacts and locations

1

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Central trial contact

Luke Connolly, PhD; Ivan C Harpham, MSc

Data sourced from clinicaltrials.gov

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