The HIIT-Home4Parkinson's Study

Parkinson's Disease Clinical Trial

— HH4P  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05485428
• Other study ID #: UPlymouthCH
• Status: Completed
• Phase: N/A
• Start date: September 1, 2023
• Est. completion date: May 1, 2024

Study information

• Verified date: May 2024
• Source: University of Plymouth
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 13
• Est. completion date: May 1, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Parkinson Disease
• Parkinson's Disease

Intervention

Other:
• High-intensity interval training
12-weeks of high intensity interval exercise, 30 minutes thrice weekly

Locations

Country	Name	City	State
United Kingdom	University Hospitals Plymouth NHS Trust	Plymouth	Devon

Sponsors (1)

Lead Sponsor	Collaborator
University of Plymouth

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	Total weekly habitual physical activity	Weekly physical activity (minutes) measured with accelerometer, self administered	During week 7 of the exercise programme
Other	Maximum heart rate	Beats per minute, to be measured during VO2max assessment	1 week before first exercise session
Other	Height	Height (centimetres) with stadiometer	1 week before first exercise session
Other	Weight	Weight (kilograms) with calibrated digital scales	1 week before first exercise session
Other	Lifestyle data questionnaire	10-item basic lifestyle data bespoke questionnaire	1 week before first exercise session
Other	Health screening questionnaire	Screening for health issues that may prevent participation	1 week before first exercise session at baseline assessments
Primary	Programme completion	Number of weeks of exercise programme completed, self administered	Through study completion, an average of 12 weeks
Primary	Programme adherence	Number of exercise sessions completed in full, self administered	Through study completion, an average of 12 weeks
Primary	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.
Primary	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	Adverse effects and events	Adverse effects and events related to exercise sessions, self administered	Through study completion, an average of 12 weeks
Secondary	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.
Secondary	Oxford Participation Activities Questionnaire	Participant administered lifestyle questionnaire	1 week before first exercise session and 1 day after last session
Secondary	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.
Secondary	Exercise intensity	Achieved exercise intensity (% of maximum heart rate), self administered	Through study completion, an average of 12 weeks