Family Health Team High-Intensity Interval Training (FHT HIIT)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type 2 Diabetes
• Intervention / Treatment: Other: Population-Based Physical Activity (PA) Advice; Other: High-Intensity Interval Training Physical Activity (PA) Advice

Detailed 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

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Michael Fernando, MD; Phone Number: 111 519-773-3715; Email: mfernando@eefht.ca

Study Locations

• Canada
  • Ontario
    • Aylmer, Ontario, Canada, N5H1K9
      • Recruiting
      • East Elgin Family Health Team
      • Contact: Michael Fernando; Email: mfernando@eefht.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Other: 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.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in HbA1C	Glycosylated Hemoglobin measured at lab	3-month and 6-month follow-up

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Weight	self-reported by participants using home scale	3-month and 6-month follow-up
Physical Activity (minutes per week)	self-reported by participants using the log books designed for this study	3-month and 6-month follow-up

Collaborators and Investigators

• Sponsor: Western University, Canada
• Collaborators: East Elgin Family Health Team

Study record dates

Study Major Dates

• Study Start (Actual): February 13, 2020
• Primary Completion (Estimated): July 13, 2026
• Study Completion (Estimated): July 13, 2026

Study Registration Dates

• First Submitted: September 12, 2019
• First Submitted That Met QC Criteria: September 27, 2019
• First Posted (Actual): September 30, 2019

Study Record Updates

• Last Update Posted (Actual): March 12, 2024
• Last Update Submitted That Met QC Criteria: March 7, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: physical activity; blood glucose; HIIT; virtual care; HbA1C
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: 111930

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No