Clinical trial NCT03545802: Home-HIT and Type 1 Diabetes
Official title: A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type1diabetes
Lead sponsor: Liverpool John Moores University
Sponsor class: OTHER
First posted: 2018-06-04
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

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.

Eligibility criteria: 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

Primary outcomes:
measure: change in maximal aerobic capacity
timeFrame: change in baseline maximal aerobic capacity at 6 weeks
measure: adherence over the course of the training programme
timeFrame: adherence to the training programme over the course of the 6 week intervention
measure: Compliance over the course of the training programme
timeFrame: compliance to the training programme over the course of the 6 week intervention
Secondary outcomes:
measure: change in insulin sensitivity
timeFrame: change in baseline insulin sensitivity at 6 weeks
measure: change in glycaemic control
timeFrame: change in baseline glycaemic control at 6 weeks
Other outcomes:
Locations:
city: Liverpool
country: United Kingdom
facility: Liverpool John Moores University
state: Merseyside
Study officials:
References:
citation: 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.