Home-HIT and Type 1 Diabetes

Sponsor
Liverpool John Moores University (Other)
Overall Status
Completed
CT.gov ID
NCT03545802
Collaborator
(none)
11
1
1
8.8
1.2

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Home-HIT
N/A

Detailed Description

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

Eleven individuals with type 1 diabetes (4 men/7 women; age 30±3 years; BMI 27.1±1.2 kg·m-2; V ̇O2peak 32.4±2.1 ml∙kg∙min-1; duration of type 1 diabetes 10±2 years) completed six weeks of Home-HIT. The effect of Home-HIT on V ̇O2peak, blood pressure, insulin dose and glycaemic profile was assessed pre and post-training. Adherence and ability to meet target heart rate (HR) thresholds (compliance) were monitored using a HR monitor and mobile phone application. Change in glycaemia was measured pre, post and 1h post exercise sessions throughout the six-week period. A qualitative online survey was completed post-training.

This is the first study to combine physiological outcomes with a qualitative evaluation of a training intervention in people with type 1 diabetes. Home-HIT resulted in high adherence alongside increased V ̇O2peak and decreased insulin dose. Because Home-HIT is time-efficient and removes barriers to exercise including fear of hypoglycaemia, it may represent an effective strategy to increase exercise participation in people with type 1 diabetes.

Study Design

Study Type:
Interventional
Actual Enrollment :
11 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
Actual Study Start Date :
May 20, 2017
Actual Primary Completion Date :
Feb 13, 2018
Actual Study Completion Date :
Feb 13, 2018

Arms and Interventions

Arm Intervention/Treatment
Experimental: Training

6 weeks of home-based high intensity interval training

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

Outcome Measures

Primary Outcome Measures

  1. change in maximal aerobic capacity [change in baseline maximal aerobic capacity at 6 weeks]

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

  2. adherence over the course of the training programme [adherence to the training programme over the course of the 6 week intervention]

    session completion rate (adherence) was assessed

  3. Compliance over the course of the training programme [compliance to the training programme over the course of the 6 week intervention]

    ability to meet target heart rates (compliance) was assessed

Secondary Outcome Measures

  1. change in insulin sensitivity [change in baseline insulin sensitivity at 6 weeks]

    insulin dose was recorded pre and post training by participants

  2. change in glycaemic control [change in baseline glycaemic control at 6 weeks]

    participants recorded their blood glucose concentrations in the first and final weeks of the intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 55 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • duration of type 1 diabetes >6 months,

  • no significant history of hyper- or hypoglycaemia

Exclusion Criteria:
  • 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Liverpool John Moores University Liverpool Merseyside United Kingdom L3 3AF

Sponsors and Collaborators

  • Liverpool John Moores University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Sam Shepherd, Lecturer/Senior Lecturer, Principle Investigator, Liverpool John Moores University
ClinicalTrials.gov Identifier:
NCT03545802
Other Study ID Numbers:
  • Home-HIT_T1D
First Posted:
Jun 4, 2018
Last Update Posted:
Mar 2, 2021
Last Verified:
Feb 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Mar 2, 2021