ObeseNCT03557736
Home-Based HIT in Obese Individuals
A study testing Training mode in people with Obese, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Obese
- What is being tested?
- Training mode
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 9 Mar 2015to 30 Jan 2018
- 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 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- obesity (BMI >30 kg/m2)
- age 18-55
Who cannot join
- diagnosed CVD and other contraindications to participate in an exercise intervention
- BMI <30 kg/m2
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Official title: 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.
Read the 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.
- Conditions
- Obese
- Being tested
- Training mode
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Training modeBehavioural
type of exercise training completed for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Home-HIT | Experimental | Home-based high-intensity interval training: participants performed 12 weeks of simple body weight exercises in a place of their own choosing 3x/week Receives: Behavioral: Training mode |
| Home-MICT | Experimental | 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 Receives: Behavioral: Training mode |
| Lab-HIT | Experimental | Laboratory-based high-intensity interval training: participants performed supervised cycle exercise under laboratory conditions 3x/week for 12 weeks Receives: Behavioral: Training mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in aerobic fitness
change in maximal aerobic capacity following the training
Measured: change in baseline aerobic fitness at 12 weeks
Adherence and compliance to the exercise training intervention
Session completion rate (adherence) and ability to meet target heart rates (compliance)
Measured: adherance and compliance to the training over the 12 weeks
Secondary outcomes (3)
change in baseline FMD
endothelial function measured using flow-mediated dilation (FMD)
Measured: change in baseline FMD at 12 weeks
change in vascular stiffness
change in vascular stiffness with training
Measured: change in baseline vascular stiffness at 12 weeks
change in body fat percentage
change in body fat percentage using DXA with training
Measured: chage in baseline body fat percentage at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2018
- Study start9 Mar 2015
- Primary completion15 Jul 2017
- Study completion30 Jan 2018
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 ObeseStudies 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Shepherd, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03557736
- Sponsor's protocol ID
- Home-HIT
- Status last verified
- Jun 2018
- First submitted
- 9 May 2018
- Last updated
- 15 Jun 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: there is no plan to share data with other researchers
Publications
Scott SN, Shepherd SO, Hopkins N, Dawson EA, Strauss JA, Wright DJ, Cooper RG, Kumar P, Wagenmakers AJM, Cocks M. Home-hit improves muscle capillarisation and eNOS/NAD(P)Hoxidase protein ratio in obese individuals with elevated cardiovascular disease risk. J Physiol. 2019 Aug;597(16):4203-4225. doi: 10.1113/JP278062. Epub 2019 Jul 15.
PubMed 31218680
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a 12-Week Home-Based High-Intensity Interval Training Programme in Obese Individuals With Elevated Cardiovascular Disease Risk: A Pilot Study
- ClinicalTrials.gov ID
- NCT03557736
- Acronym / sponsor ID
- Home-HIT
- Conditions
- Obese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 9 Mar 2015 (actual)
- Primary completion
- 15 Jul 2017 (actual)
- Study completion
- 30 Jan 2018 (actual)
- First posted
- 15 Jun 2018 (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 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.
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 design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Home-HIT | Experimental | Behavioral: Training modeHome-based high-intensity interval training: participants performed 12 weeks of simple body weight exercises in a place of their own choosing 3x/week |
| Home-MICT | Experimental | Behavioral: Training modeHome-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 |
| Lab-HIT | Experimental | Behavioral: Training modeLaboratory-based high-intensity interval training: participants performed supervised cycle exercise under laboratory conditions 3x/week for 12 weeks |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- obesity (BMI >30 kg/m2)
- age 18-55
Key exclusion criteria (2 listed)
- diagnosed CVD and other contraindications to participate in an exercise intervention
- BMI <30 kg/m2
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 |
|---|---|---|
| Training modetype of exercise training completed for 12 weeks | Behavioural | Home-HIT, Home-MICT, Lab-HIT |
Primary outcome
change in aerobic fitness
Time frame: change in baseline aerobic fitness at 12 weeks
change in maximal aerobic capacity following the training
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)
3 secondary outcomes
change in baseline FMD
Time frame: change in baseline FMD at 12 weeks
change in vascular stiffness
Time frame: change in baseline vascular stiffness at 12 weeks
change in body fat percentage
Time frame: chage in baseline body fat percentage at 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 15 Jun 2018.
- Derived from this study: PubMed 31218680Scott SN, Shepherd SO, Hopkins N, Dawson EA, Strauss JA, Wright DJ, Cooper RG, Kumar P, Wagenmakers AJM, Cocks M. Home-hit improves muscle capillarisation and eNOS/NAD(P)Hoxidase protein ratio in obese individuals with elevated cardiovascular disease risk. J Physiol. 2019 Aug;597(16):4203-4225. doi: 10.1113/JP278062. Epub 2019 Jul 15.
- Individual participant dataSharing planned: No. there is no plan to share data with other researchers
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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 Training mode in people with Obese, run by Liverpool John Moores University 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 2 inclusion and 2 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 15 Jun 2018. 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?
change in aerobic fitness (time frame: change in baseline aerobic fitness at 12 weeks). The study lists 2 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 NCT03557736, 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 15 Jun 2018; AzTrials last refreshed its copy on 27 Oct 2026.