The HIIT-Home4Parkinson's Study (HH4P)

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

Study Overview

• Status: Completed
• Conditions: Parkinson's Disease
• Intervention / Treatment: Other: High-intensity interval training

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.

• Study Type: Interventional
• Enrollment (Actual): 13
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Devon
    • Plymouth, Devon, United Kingdom, PL68DH
      • University Hospitals Plymouth NHS Trust

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Programme completion	Number of weeks of exercise programme completed, self administered	Through study completion, an average of 12 weeks
Programme adherence	Number of exercise sessions completed in full, self administered	Through study completion, an average of 12 weeks
Change from baseline brain derived neurotrophic factor (BDNF)	Blood sample: Brain-derived neurotrophic factor (pg/ml)	1 week before first exercise session and 1 day after last session.
Change from baseline Relative VO2max	Maximal oxygen uptake (ml/min/kg) incremental exercise test	1 week before first exercise session and 1 day after last session.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Exercise intensity	Achieved exercise intensity (% of maximum heart rate), self administered	Through study completion, an average of 12 weeks
Adverse effects and events	Adverse effects and events related to exercise sessions, self administered	Through study completion, an average of 12 weeks
Change from baseline 30 second sit to stand test	Number of times standing in 30 seconds	1 week before first exercise session and 1 day after last session.
Oxford Participation Activities Questionnaire	Participant administered lifestyle questionnaire	1 week before first exercise session and 1 day after last session
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	1 week before first exercise session and 1 day after last session.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total weekly habitual physical activity	Weekly physical activity (minutes) measured with accelerometer, self administered	1 week prior to start of exercise programme after baseline assessments
Total weekly habitual physical activity	Weekly physical activity (minutes) measured with accelerometer, self administered	During week 7 of the exercise programme
Maximum heart rate	Beats per minute, to be measured during VO2max assessment	1 week before first exercise session
Height	Height (centimetres) with stadiometer	1 week before first exercise session
Weight	Weight (kilograms) with calibrated digital scales	1 week before first exercise session
Lifestyle data questionnaire	10-item basic lifestyle data bespoke questionnaire	1 week before first exercise session
Health screening questionnaire	Screening for health issues that may prevent participation	1 week before first exercise session at baseline assessments

Collaborators and Investigators

• Sponsor: University of Plymouth

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2023
• Primary Completion (Actual): April 25, 2024
• Study Completion (Actual): May 1, 2024

Study Registration Dates

• First Submitted: July 27, 2022
• First Submitted That Met QC Criteria: August 2, 2022
• First Posted (Actual): August 3, 2022

Study Record Updates

• Last Update Posted (Actual): May 9, 2024
• Last Update Submitted That Met QC Criteria: May 7, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: Training; Exercise; HIIT; Home-based; Neurodegenerative; Physical; High-intensity; Interval
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Parkinson Disease
• Other Study ID Numbers: UPlymouthCH

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (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
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No