Family Health Team High-Intensity Interval Training

Type 2 Diabetes Clinical Trial

— FHT HIIT  

Official title:

IS SHORT-DURATION, HIGH-INTENSITY-INTERVAL TRAINING (HIIT) SUPERIOR TO POPULATION-BASED MODERATE-INTENSITY PHYSICAL ACTIVITY GUIDELINES FOR INDIVIDUALS WITH TYPE 2 DIABETES? A PILOT STUDY

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04109235
• Other study ID #: 111930
• Status: Recruiting
• Phase: N/A
• Start date: February 13, 2020
• Est. completion date: July 13, 2026

Study information

• Verified date: March 2024
• Source: Western University, Canada
• Contact: Michael Fernando, MD
• Phone: 519-773-3715
• Email: mfernando[@]eefht.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

With the rapid shift to virtual care, this pilot study aims to determine the feasibility of prescribing low-duration, interval-based training through virtual care. If successful, this study will inform a larger randomized control trial to determine if the prescription of low-duration interval-based training improves chronic disease through the measurement of hemoglobin A1C (HbA1C), and weight to a greater extent than the general guideline to aim for 150 minutes of PA weekly.

Description:

Dr. Fernando will invite patients to participate in this trial during their virtual diabetes appointments at the East Elgin Family Health Team (EEFHT). Participants will be randomized 1:1 using computer-generated randomization software to receive either a population-based, standard activity intervention (control group) or a high-intensity interval training (HIIT) intervention, which they will complete on their own time, at the location of their choosing (at home, gym, outside, or elsewhere). Data will be collected at baseline (T1), and participants will be followed up after 3 months (T2) and 6 months (T3). All data acquisition is from standard of care (i.e. patients are already seen every 3 months for diabetes visits). Data collection at T1, T2 and T3 will include:

• Weight and Height (measured using the Health-O-Meter weigh scale, used to calculate BMI)

• Minutes of PA (self-reported by participants using the log books designed for this study)

• HbA1C (requisition will be provided by Dr. Fernando. Patients will be exempt from completing the baseline HbA1C if they have had a HbA1C measurement in the past 30 days & the patient has not made significant lifestyle changes or had any blood glucose medications changed; in this case, the measurement completed in the past 30 days will be used as the baseline measure)

• Blood glucose and blood pressure medications

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: July 13, 2026
• Est. primary completion date: July 13, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adults, at least 18 years of age

• non-pregnant

• having a diagnosis of type 2 diabetes in accordance with the 2018 Diabetes Canada Clinical Practice Guidelines

• capable of consenting

• deemed capable and safe to exercise by their physician (Dr. Fernando)

• without a medical history of myocardial infarction in the past three months.

Exclusion Criteria:

• < 18 years of age

• pregnant

• not having a type 2 diabetes diagnosis

• having a medical history of myocardial infarction in the past 3 months

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• High-Intensity Interval Training Physical Activity (PA) Advice
This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a High-Intensity-Interval-Training (HIIT) handout (developed based on research from Dr. Martin Gibala) detailing their PA recommendations. Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.
• Population-Based Physical Activity (PA) Advice
This PA intervention will be primarily self-directed by the patients themselves. Each participant will receive a 1-page double-sided handout detailing their PA protocol. Participants in this arm will receive a CSEP handout (page 4&5 from: http://csep.ca/CMFiles/Guidelines/CSEP_PAGuidelines_0-65plus_en.pdf) detailing their PA recommendations.Participants will be instructed to follow their PA protocol, while noting down which days they completed the PA using a log booklet provided to them by Dr. Fernando (their family physician). Participants will be provided with the phone number for a research assistant who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, the research assistant will respond to these over the phone.

Locations

Country	Name	City	State
Canada	East Elgin Family Health Team	Aylmer	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Western University, Canada	East Elgin Family Health Team

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in HbA1C	Glycosylated Hemoglobin measured at lab	3-month and 6-month follow-up
Secondary	Weight	self-reported by participants using home scale	3-month and 6-month follow-up
Secondary	Physical Activity (minutes per week)	self-reported by participants using the log books designed for this study	3-month and 6-month follow-up