- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03557736
Home-Based HIT in Obese Individuals
June 4, 2018 updated by: Sam Shepherd, Liverpool John Moores University
Effects of a 12-Week Home-Based High-Intensity Interval Training Programme in Obese Individuals With Elevated Cardiovascular Disease Risk: A Pilot Study
This study aims to investigate the efficacy of a novel home-based high-intensity interval training (Home-HIT) intervention in obese individuals, with elevated cardiovascular disease (CVD) risk.
It was hypothesised that Home-HIT would 1) have high adherence to the prescribed exercise intensity (compliance), 2) improve markers of CVD risk, and 3) lead to favourable skeletal muscle adaptations.
Study Overview
Detailed Description
The applicability of current high intensity interval training (HIT) protocols to the sedentary obese population has been disputed by public health experts.
Existing HIT interventions have been successful only under optimal conditions with high levels of supervision and specialised equipment, creating further barriers to exercise in those most in need.
We aimed to eliminate many of these barriers by modifying existing HIT protocols to create a new home-based HIT (Home-HIT) intervention tailored to individuals with low fitness and mobility.
It was hypothesised that Home-HIT would 1) have high adherence to the prescribed exercise intensity (compliance) and 2) improve markers of cardiovascular disease (CVD) risk.
32 Obese adults with at least 3 additional CVD risk factors (age 36±2 y; BMI 34.3±0.8
kg∙m-2; VO2peak 24.6±1.0
ml∙kg∙min-1), completed one of three 12-week training programmes 3x/week: Home-HIT (n=9); Laboratory-based supervised HIT (Lab-HIT; n=10) or home-based moderate intensity continuous training (Home-MICT; n=13).
Adherence and compliance were monitored online in almost "real time" using a heart rate (HR) monitor and mobile app.
The Home-HIT group completed 4 progressing to 8 1min intervals interspersed with 1min of rest in an unsupervised place of their choosing.
The intervals were composed of simple bodyweight exercises that required no equipment.
Changes in VO2peak, insulin sensitivity, body composition, flow-mediated dilation (FMD) and aortic pulse wave velocity (PWV) were assessed.
Muscle biopsies were taken to assess changes in capillarisation, mitochondrial density, intramuscular triglyceride (IMTG) content and eNOS and GLUT4 protein expression using quantitative immunofluorescence microscopy.
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Merseyside
-
Liverpool, Merseyside, United Kingdom, L3 3AF
- Liverpool John Moores University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- obesity (BMI >30 kg/m2)
- age 18-55
Exclusion Criteria:
- diagnosed CVD and other contraindications to participate in an exercise intervention
- BMI <30 kg/m2
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Home-HIT
Home-based high-intensity interval training: participants performed 12 weeks of simple body weight exercises in a place of their own choosing 3x/week
|
type of exercise training completed for 12 weeks
|
|
Experimental: Home-MICT
Home-based moderate-intensity interval training: participants performed 12 weeks of continuous exercise (running, swimming or cycling) in a place of their own choosing 3x/week
|
type of exercise training completed for 12 weeks
|
|
Experimental: Lab-HIT
Laboratory-based high-intensity interval training: participants performed supervised cycle exercise under laboratory conditions 3x/week for 12 weeks
|
type of exercise training completed for 12 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in aerobic fitness
Time Frame: change in baseline aerobic fitness at 12 weeks
|
change in maximal aerobic capacity following the training
|
change in baseline aerobic fitness at 12 weeks
|
|
Adherence and compliance to the exercise training intervention
Time Frame: adherance and compliance to the training over the 12 weeks
|
Session completion rate (adherence) and ability to meet target heart rates (compliance)
|
adherance and compliance to the training over the 12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
change in baseline FMD
Time Frame: change in baseline FMD at 12 weeks
|
endothelial function measured using flow-mediated dilation (FMD)
|
change in baseline FMD at 12 weeks
|
|
change in vascular stiffness
Time Frame: change in baseline vascular stiffness at 12 weeks
|
change in vascular stiffness with training
|
change in baseline vascular stiffness at 12 weeks
|
|
change in body fat percentage
Time Frame: chage in baseline body fat percentage at 12 weeks
|
change in body fat percentage using DXA with training
|
chage in baseline body fat percentage at 12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 9, 2015
Primary Completion (Actual)
July 15, 2017
Study Completion (Actual)
January 30, 2018
Study Registration Dates
First Submitted
May 9, 2018
First Submitted That Met QC Criteria
June 4, 2018
First Posted (Actual)
June 15, 2018
Study Record Updates
Last Update Posted (Actual)
June 15, 2018
Last Update Submitted That Met QC Criteria
June 4, 2018
Last Verified
June 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Home-HIT
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
there is no plan to share data with other researchers
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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