Home-HIT and Type 1 Diabetes

Type1diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03545802
• Other study ID #: Home-HIT_T1D
• Status: Completed
• Phase: N/A
• Start date: May 20, 2017
• Est. completion date: February 13, 2018

Study information

• Verified date: February 2021
• Source: Liverpool John Moores University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 11
• Est. completion date: February 13, 2018
• Est. primary completion date: February 13, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type1diabetes

Intervention

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

Locations

Country	Name	City	State
United Kingdom	Liverpool John Moores University	Liverpool	Merseyside

Sponsors (1)

Lead Sponsor	Collaborator
Liverpool John Moores University

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	change in insulin sensitivity	insulin dose was recorded pre and post training by participants	change in baseline insulin sensitivity at 6 weeks
Secondary	change in glycaemic control	participants recorded their blood glucose concentrations in the first and final weeks of the intervention	change in baseline glycaemic control at 6 weeks