NCT03545802

Brief Summary

This study aimed to use a multi-disciplinary approach to evaluate a 6-week home-based high-intensity interval training (Home-HIT) intervention in people with type 1 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
11

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2017

Shorter than P25 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

May 20, 2017

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 13, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 13, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

May 9, 2018

Completed
26 days until next milestone

First Posted

Study publicly available on registry

June 4, 2018

Completed
Last Updated

March 2, 2021

Status Verified

February 1, 2021

Enrollment Period

9 months

First QC Date

May 9, 2018

Last Update Submit

February 26, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • change in maximal aerobic capacity

    Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer

    change in baseline maximal aerobic capacity at 6 weeks

  • adherence over the course of the training programme

    session completion rate (adherence) was assessed

    adherence to the training programme over the course of the 6 week intervention

  • Compliance over the course of the training programme

    ability to meet target heart rates (compliance) was assessed

    compliance to the training programme over the course of the 6 week intervention

Secondary Outcomes (2)

  • change in insulin sensitivity

    change in baseline insulin sensitivity at 6 weeks

  • change in glycaemic control

    change in baseline glycaemic control at 6 weeks

Study Arms (1)

Training

EXPERIMENTAL

6 weeks of home-based high intensity interval training

Behavioral: Home-HIT

Interventions

Home-HITBEHAVIORAL

Participants completed 6 weeks of home-based high-intensity interval training 3 times per week

Training

Eligibility Criteria

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

You may qualify if:

  • duration of type 1 diabetes \>6 months,
  • no significant history of hyper- or hypoglycaemia

You may not qualify if:

  • duration of type 1 diabetes \<6 months,
  • significant history of hyper- or hypoglycaemia,
  • pregnancy or planning pregnancy,
  • uncontrolled hypertension (\>180/100 mmHg),
  • angina
  • autonomic neuropathy,
  • taking any medication that affects heart rate (HR)
  • major surgery planned within 6 weeks of the study
  • severe nonproliferative
  • unstable proliferative retinopathy

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, Andrews RC, Narendran P, Purewal TS, Kinnafick F, Cuthbertson DJ, Atkinson-Goulding S, Noon T, Wagenmakers AJM, Cocks M. A Multidisciplinary Evaluation of a Virtually Supervised Home-Based High-Intensity Interval Training Intervention in People With Type 1 Diabetes. Diabetes Care. 2019 Dec;42(12):2330-2333. doi: 10.2337/dc19-0871. Epub 2019 Sep 17.

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer/Senior Lecturer, Principle Investigator

Study Record Dates

First Submitted

May 9, 2018

First Posted

June 4, 2018

Study Start

May 20, 2017

Primary Completion

February 13, 2018

Study Completion

February 13, 2018

Last Updated

March 2, 2021

Record last verified: 2021-02

Data Sharing

IPD Sharing
Will not share

no plan to share

Locations