University Hospitals Plymouth NHS Trust
Plymouth, Devon, PL68DH, United Kingdom
NCT Number: NCT05485428
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).
Looking for future studies?
Notify Me18 year and older
All sexes
Interventional
Not applicable
Plymouth, Devon, PL68DH, United Kingdom
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
12-weeks of high intensity interval exercise, 30 minutes thrice weekly
Time frame: Through study completion, an average of 12 weeks
Number of weeks of exercise programme completed, self administered
Time frame: Through study completion, an average of 12 weeks
Number of exercise sessions completed in full, self administered
Time frame: 1 week before first exercise session and 1 day after last session.
Blood sample: Brain-derived neurotrophic factor (pg/ml)
Time frame: 1 week before first exercise session and 1 day after last session.
Maximal oxygen uptake (ml/min/kg) incremental exercise test
Time frame: Through study completion, an average of 12 weeks
Adverse effects and events related to exercise sessions, self administered
Time frame: 1 week before first exercise session and 1 day after last session.
Number of times standing in 30 seconds
Time frame: 1 week before first exercise session and 1 day after last session
Participant administered lifestyle questionnaire
Time frame: 1 week before first exercise session and 1 day after last session.
Motor examination, minimum score 0, maximum score 76, higher scores indicate increased disease severity
Time frame: Through study completion, an average of 12 weeks
Achieved exercise intensity (% of maximum heart rate), self administered
Time frame: 1 week prior to start of exercise programme after baseline assessments
Weekly physical activity (minutes) measured with accelerometer, self administered
Time frame: During week 7 of the exercise programme
Weekly physical activity (minutes) measured with accelerometer, self administered
Time frame: 1 week before first exercise session
Beats per minute, to be measured during VO2max assessment
Time frame: 1 week before first exercise session
Height (centimetres) with stadiometer
Time frame: 1 week before first exercise session
Weight (kilograms) with calibrated digital scales
Time frame: 1 week before first exercise session
10-item basic lifestyle data bespoke questionnaire
Time frame: 1 week before first exercise session at baseline assessments
Screening for health issues that may prevent participation
University of Plymouth
Other
Home-based High-intensity Interval Training for People With Parkinson's: The HIIT-Home4Parkinson's Randomised Controlled Feasibility Study
Acronym: HH4P
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05298150
Basal Ganglia Diseases, Behavior
Cleveland, Ohio, United States
View Trial DetailsNCT03808675
Adherence Interventions, Basal Ganglia Diseases
Iowa City, Iowa, United States
View Trial DetailsNCT02598973
Basal Ganglia Diseases, Behavior
Philadelphia, Pennsylvania, United States
View Trial DetailsNCT05575479
Basal Ganglia Diseases, Behavior
Columbus, Ohio, United States
View Trial Details