Parkinson's DiseaseHH4PNCT05485428
The HIIT-Home4Parkinson's Study
A study testing High-intensity interval training in people with Parkinson's Disease, run by University of Plymouth at 1 site in United Kingdom.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Parkinson's Disease
- What is being tested?
- High-intensity interval training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2023to 1 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United Kingdom1 site
University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL68DH
About this study
Official title: 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).
Read the 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.
- Conditions
- Parkinson's Disease
- Being tested
- High-intensity interval training
- Keywords
- HIIT, Exercise, Neurodegenerative, Physical, High-intensity, Interval, Home-based, Training
- Medical subject headings
- Parkinson Disease, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-intensity interval trainingOther
12-weeks of high intensity interval exercise, 30 minutes thrice weekly
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | High-intensity interval training plus usual care Receives: Other: High-intensity interval training |
| Usual care | No intervention | Usual care / treatment. Usual physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Programme completion
Number of weeks of exercise programme completed, self administered
Measured: Through study completion, an average of 12 weeks
Programme adherence
Number of exercise sessions completed in full, self administered
Measured: Through study completion, an average of 12 weeks
Change from baseline brain derived neurotrophic factor (BDNF)
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Measured: 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
Measured: 1 week before first exercise session and 1 day after last session.
Secondary outcomes (5)
Adverse effects and events
Adverse effects and events related to exercise sessions, self administered
Measured: Through study completion, an average of 12 weeks
Change from baseline 30 second sit to stand test
Number of times standing in 30 seconds
Measured: 1 week before first exercise session and 1 day after last session.
Oxford Participation Activities Questionnaire
Participant administered lifestyle questionnaire
Measured: 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
Measured: 1 week before first exercise session and 1 day after last session.
Exercise intensity
Achieved exercise intensity (% of maximum heart rate), self administered
Measured: Through study completion, an average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2022
- Study start1 Sep 2023
- Primary completion25 Apr 2024
- Study completion1 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Parkinson's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Plymouth
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, (Ivan) Conrad Harpham, University of Plymouth
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05485428
- Sponsor's protocol ID
- UPlymouthCH
- Acronym
- HH4P
- Status last verified
- May 2024
- First submitted
- 27 Jul 2022
- Last updated
- 9 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 40661734
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study
- ClinicalTrials.gov ID
- NCT05485428
- Acronym / sponsor ID
- HH4P / UPlymouthCH
- Conditions
- Parkinson's Disease
- Keywords
- HIIT, Exercise, Neurodegenerative, Physical, High-intensity, Interval, Home-based, Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- University of PlymouthUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 25 Apr 2024 (actual)
- Study completion
- 1 May 2024 (actual)
- First posted
- 3 Aug 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomised controlled feasibility study with mechanistic, physiological and clinical sub components
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: High-intensity interval trainingHigh-intensity interval training plus usual care |
| Usual care | No intervention | –Usual care / treatment. Usual physical activity. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High-intensity interval training12-weeks of high intensity interval exercise, 30 minutes thrice weekly | Other | Exercise |
Primary outcome
Programme completion
Time frame: Through study completion, an average of 12 weeks
Number of weeks of exercise programme completed, self administered
Programme adherence
Time frame: Through study completion, an average of 12 weeks
Number of exercise sessions completed in full, self administered
Change from baseline brain derived neurotrophic factor (BDNF)
Time frame: 1 week before first exercise session and 1 day after last session.
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Change from baseline Relative VO2max
Time frame: 1 week before first exercise session and 1 day after last session.
Maximal oxygen uptake (ml/min/kg) incremental exercise test
5 secondary outcomes
Adverse effects and events
Time frame: Through study completion, an average of 12 weeks
Change from baseline 30 second sit to stand test
Time frame: 1 week before first exercise session and 1 day after last session.
Oxford Participation Activities Questionnaire
Time frame: 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
Time frame: 1 week before first exercise session and 1 day after last session.
Exercise intensity
Time frame: Through study completion, an average of 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
- Derived from this study: PubMed 40661734Harpham 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.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High-intensity interval training in people with Parkinson's Disease, run by University of Plymouth at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Programme completion (time frame: Through study completion, an average of 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05485428, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 May 2024.