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Completed

NCT Number: NCT03545802

Home-HIT and Type 1 Diabetes

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.

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Key information

Conditions

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

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Home-HIT

Behavioral

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

Primary outcomes

  1. change in maximal aerobic capacity

    Time frame: 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

    Time frame: 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

    Time frame: compliance to the training programme over the course of the 6 week intervention

    ability to meet target heart rates (compliance) was assessed

Secondary outcomes

  1. change in insulin sensitivity

    Time frame: change in baseline insulin sensitivity at 6 weeks

    insulin dose was recorded pre and post training by participants

  2. change in glycaemic control

    Time frame: change in baseline glycaemic control at 6 weeks

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

Sponsors and collaborators

Lead sponsor

Liverpool John Moores University

Other

Registry information

Official study title

A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jun 4, 2018
Registry last updated
Mar 2, 2021

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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