NCT03557736

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Mar 2015

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 9, 2015

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2017

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 15, 2018

Completed
Last Updated

June 15, 2018

Status Verified

June 1, 2018

Enrollment Period

2.4 years

First QC Date

May 9, 2018

Last Update Submit

June 4, 2018

Conditions

Outcome Measures

Primary Outcomes (2)

  • change in aerobic fitness

    change in maximal aerobic capacity following the training

    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)

    adherance and compliance to the training over the 12 weeks

Secondary Outcomes (3)

  • change in baseline FMD

    change in baseline FMD at 12 weeks

  • change in vascular stiffness

    change in baseline vascular stiffness at 12 weeks

  • change in body fat percentage

    chage in baseline body fat percentage at 12 weeks

Study Arms (3)

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

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

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

Behavioral: Training mode

Interventions

Training modeBEHAVIORAL

type of exercise training completed for 12 weeks

Home-HITHome-MICTLab-HIT

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • obesity (BMI \>30 kg/m2)
  • age 18-55

You may not qualify if:

  • diagnosed CVD and other contraindications to participate in an exercise intervention
  • BMI \<30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Liverpool John Moores University

Liverpool, Merseyside, L3 3AF, United Kingdom

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr Sam Shepherd

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 15, 2018

Study Start

March 9, 2015

Primary Completion

July 15, 2017

Study Completion

January 30, 2018

Last Updated

June 15, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

there is no plan to share data with other researchers

Locations