Type1diabetesNCT03545802
Home-HIT and Type 1 Diabetes
A study testing Home-HIT in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Type1diabetes
- What is being tested?
- Home-HIT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 20 May 2017to 13 Feb 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- duration of type 1 diabetes >6 months,
- no significant history of hyper- or hypoglycaemia
Who cannot join
- 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,
Show all 10Show fewer
- taking any medication that affects heart rate (HR)
- major surgery planned within 6 weeks of the study
- severe nonproliferative
- unstable proliferative retinopathy
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Liverpool John Moores University
Liverpool, Merseyside, L3 3AF
About this study
Official title: A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
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.
Read the 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.
- Conditions
- Type1diabetes
- Being tested
- Home-HIT
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Home-HITBehavioural
Participants completed 6 weeks of home-based high-intensity interval training 3 times per week
| Study group | Role | What they receive |
|---|---|---|
| Training | Experimental | 6 weeks of home-based high intensity interval training Receives: Behavioral: Home-HIT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: change in baseline maximal aerobic capacity at 6 weeks
adherence over the course of the training programme
session completion rate (adherence) was assessed
Measured: adherence to the training programme over the course of the 6 week intervention
Compliance over the course of the training programme
ability to meet target heart rates (compliance) was assessed
Measured: compliance to the training programme over the course of the 6 week intervention
Secondary outcomes (2)
change in insulin sensitivity
insulin dose was recorded pre and post training by participants
Measured: change in baseline insulin sensitivity at 6 weeks
change in glycaemic control
participants recorded their blood glucose concentrations in the first and final weeks of the intervention
Measured: change in baseline glycaemic control at 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2018
- Study start20 May 2017
- Primary completion13 Feb 2018
- Study completion13 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type1diabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sam Shepherd, Liverpool John Moores University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03545802
- Sponsor's protocol ID
- Home-HIT_T1D
- Status last verified
- Feb 2021
- First submitted
- 9 May 2018
- Last updated
- 2 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share
Publications
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.
PubMed 31530660
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Disciplinary Evaluation of Home-Based High-Intensity Interval Training in People With Type 1 Diabetes: A Pilot Study
- ClinicalTrials.gov ID
- NCT03545802
- Acronym / sponsor ID
- Home-HIT_T1D
- Conditions
- Type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 20 May 2017 (actual)
- Primary completion
- 13 Feb 2018 (actual)
- Study completion
- 13 Feb 2018 (actual)
- First posted
- 4 Jun 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Training | Experimental | Behavioral: Home-HIT6 weeks of home-based high intensity interval training |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- duration of type 1 diabetes >6 months,
- no significant history of hyper- or hypoglycaemia
Key exclusion criteria (10 listed)
- duration of type 1 diabetes <6 months,
- significant history of hyper- or hypoglycaemia,
- pregnancy or planning pregnancy,
- uncontrolled hypertension (>180/100 mmHg),
- angina
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Home-HITParticipants completed 6 weeks of home-based high-intensity interval training 3 times per week | Behavioural | Training |
Primary outcome
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
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
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
2 secondary outcomes
change in insulin sensitivity
Time frame: change in baseline insulin sensitivity at 6 weeks
change in glycaemic control
Time frame: change in baseline glycaemic control at 6 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2021.
- Derived from this study: PubMed 31530660Scott 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.
- Individual participant dataSharing planned: No. no plan to share
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Home-HIT in people with Type1diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
change in maximal aerobic capacity (time frame: change in baseline maximal aerobic capacity at 6 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03545802, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Mar 2021.