Recruiting

High-Intensity Interval Training

Sponsor:

Western University, Canada

Code:

NCT04109235

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

High-Intensity Interval Training Physical Activity (PA) Advice

Population-Based Physical Activity (PA) Advice

Study Details

Brief 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.

Conditions

Type 2 Diabetes

Study ID

NCT04109235

Start date

Feb 13, 2020

Status verified date

Mar, 2024

Completion date

Jul 13, 2026

Anticipated

Primary completion date

Jul 13, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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

Study Design

Enrollment

20 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: 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.

experimental: 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.

Interventions

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.

Primary outcome measure

  • Change in HbA1C [ Time Frame: 3-month and 6-month follow-up ]

Central Contacts and Locations

Central contacts

Michael Fernando, MD

519-773-3715mfernando@eefht.ca

Locations

East Elgin Family Health Team

Recruiting

Aylmer, Ontario, Canada, N5H1K9

Contacts

Michael Fernando

mfernando@eefht.ca

More Information

Sponsor

Western University, Canada

Last update posted

Mar 12, 2024

Last verified

Mar, 2024

Keywords

  • HbA1C
  • virtual care
  • blood glucose
  • physical activity
  • HIIT

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Western University, Canada on 2024-03-12.