Home-HIT and Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type1diabetes
• Interventions: Behavioral: Home-HIT

• Registration Number: NCT03545802
• Lead Sponsor: Liverpool John Moores University

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.

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 Timeline

• Study Start: 2017-05-20
• Primary Completion: 2018-02-13
• Study Completion: 2018-02-13
• Study First Submitted: 2018-05-09
• Study First Submitted QC: 2018-06-01
• Study First Posted: 2018-06-04
• Status Verified: 2021-02
• Last Update Submitted: 2021-02-26
• Last Update Posted: 2021-03-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 11

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Training	Home-HIT	6 weeks of home-based high intensity interval training

Primary Outcome Measures

Name	Time	Method
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
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
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

Secondary Outcome Measures

Name	Time	Method
change in insulin sensitivity	change in baseline insulin sensitivity at 6 weeks	insulin dose was recorded pre and post training by participants
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

Trial Locations

Locations (1)

Liverpool John Moores University; 🇬🇧 Liverpool, Merseyside, United Kingdom