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Completed

NCT Number: NCT03557736

Home-Based HIT in Obese Individuals

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.

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Key information

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Training mode

Behavioral

type of exercise training completed for 12 weeks

Primary outcomes

  1. change in aerobic fitness

    Time frame: change in baseline aerobic fitness at 12 weeks

    change in maximal aerobic capacity following the training

  2. 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)

Secondary outcomes

  1. change in baseline FMD

    Time frame: change in baseline FMD at 12 weeks

    endothelial function measured using flow-mediated dilation (FMD)

  2. change in vascular stiffness

    Time frame: change in baseline vascular stiffness at 12 weeks

    change in vascular stiffness with training

  3. 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

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

Effects of a 12-Week Home-Based High-Intensity Interval Training Programme in Obese Individuals With Elevated Cardiovascular Disease Risk: A Pilot Study

Important dates

Study start
2015
Primary completion
2017
Study completion
2018
First posted
Jun 15, 2018
Registry last updated
Jun 15, 2018

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.

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