The HIIT-Home4Parkinson's Study

NCT05485428 | Completed

• 1 other identifier: UPlymouthCH
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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).

Conditions

Parkinson's Disease

Keywords

HIIT; Exercise; Neurodegenerative; Physical; High-intensity; Interval; Home-based; Training

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (5)

• Adverse effects and events

  Through study completion, an average of 12 weeks

• Change from baseline 30 second sit to stand test

  1 week before first exercise session and 1 day after last session.

• Oxford Participation Activities 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

  1 week before first exercise session and 1 day after last session.

• Exercise intensity

  Through study completion, an average of 12 weeks

Other Outcomes (7)

• Total weekly habitual physical activity

  1 week prior to start of exercise programme after baseline assessments

• Total weekly habitual physical activity

  During week 7 of the exercise programme

• Maximum heart rate

  1 week before first exercise session

Study Arms (2)

Exercise

EXPERIMENTAL

High-intensity interval training plus usual care

Other: High-intensity interval training

Usual care

NO INTERVENTION

Usual care / treatment. Usual physical activity.

Interventions

High-intensity interval training OTHER

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

Exercise

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Plymouth: lead

Study Sites (1)

University Hospitals Plymouth NHS Trust

Plymouth, Devon, PL68DH, United Kingdom

Location

Related Publications (1)

• 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.

  PMID: 40661734 DERIVED

MeSH Terms

Conditions

Parkinson Disease; Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases; Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessor blinded to group allocation
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD student, Principal Investigator

Model Details: Randomised controlled feasibility study with mechanistic, physiological and clinical sub components

Study Record Dates

• First Submitted: July 27, 2022
• First Posted: August 3, 2022
• Study Start: September 1, 2023
• Primary Completion: April 25, 2024
• Study Completion: May 1, 2024
• Last Updated: May 9, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: De-identified data will be available for a period of 10 years in line with University of Plymouth policy
• Access Criteria: On request

Locations

GB (1)