Home-HIT and Type 1 Diabetes
Primary Purpose
Type1diabetes
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Home-HIT
Sponsored by
About this trial
This is an interventional basic science trial for Type1diabetes
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
Sites / Locations
- Liverpool John Moores University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Training
Arm Description
6 weeks of home-based high intensity interval training
Outcomes
Primary Outcome Measures
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
adherence over the course of the training programme
session completion rate (adherence) was assessed
Compliance over the course of the training programme
ability to meet target heart rates (compliance) was assessed
Secondary Outcome Measures
change in insulin sensitivity
insulin dose was recorded pre and post training by participants
change in glycaemic control
participants recorded their blood glucose concentrations in the first and final weeks of the intervention
Full Information
NCT ID
NCT03545802
First Posted
May 9, 2018
Last Updated
February 26, 2021
Sponsor
Liverpool John Moores University
1. Study Identification
Unique Protocol Identification Number
NCT03545802
Brief Title
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
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
May 20, 2017 (Actual)
Primary Completion Date
February 13, 2018 (Actual)
Study Completion Date
February 13, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Liverpool John Moores University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1diabetes
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
11 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Training
Arm Type
Experimental
Arm Description
6 weeks of home-based high intensity interval training
Intervention Type
Behavioral
Intervention Name(s)
Home-HIT
Intervention Description
Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
Primary Outcome Measure Information:
Title
change in maximal aerobic capacity
Description
Maximal aerobic capacity was measured pre and post 6 week training intervention using a MOXUS gas analyser on a stationary cycle ergometer
Time Frame
change in baseline maximal aerobic capacity at 6 weeks
Title
adherence over the course of the training programme
Description
session completion rate (adherence) was assessed
Time Frame
adherence to the training programme over the course of the 6 week intervention
Title
Compliance over the course of the training programme
Description
ability to meet target heart rates (compliance) was assessed
Time Frame
compliance to the training programme over the course of the 6 week intervention
Secondary Outcome Measure Information:
Title
change in insulin sensitivity
Description
insulin dose was recorded pre and post training by participants
Time Frame
change in baseline insulin sensitivity at 6 weeks
Title
change in glycaemic control
Description
participants recorded their blood glucose concentrations in the first and final weeks of the intervention
Time Frame
change in baseline glycaemic control at 6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Liverpool John Moores University
City
Liverpool
State/Province
Merseyside
ZIP/Postal Code
L3 3AF
Country
United Kingdom
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share
Citations:
PubMed Identifier
31530660
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.
Results Reference
derived
Learn more about this trial
Home-HIT and Type 1 Diabetes
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