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

Primary Purpose

Type 2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
High-Intensity Interval Training Physical Activity (PA) Advice
Population-Based Physical Activity (PA) Advice
Sponsored by
Western University, Canada
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes focused on measuring HbA1C, virtual care, blood glucose, physical activity, HIIT

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • East Elgin Family Health TeamRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Population-Based Physical Activity (PA) Advice

High-Intensity Interval Training Physical Activity (PA) Advice

Arm Description

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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.

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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.

Outcomes

Primary Outcome Measures

Change in HbA1C
Glycosylated Hemoglobin measured at lab

Secondary Outcome Measures

Weight
self-reported by participants using home scale
Physical Activity (minutes per week)
self-reported by participants using the log books designed for this study

Full Information

First Posted
September 12, 2019
Last Updated
April 26, 2021
Sponsor
Western University, Canada
Collaborators
East Elgin Family Health Team
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1. Study Identification

Unique Protocol Identification Number
NCT04109235
Brief Title
Family Health Team High-Intensity Interval Training
Acronym
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 IN VIRTUAL HEALTHCARE
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Unknown status
Study Start Date
February 13, 2020 (Actual)
Primary Completion Date
July 13, 2021 (Anticipated)
Study Completion Date
July 13, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Western University, Canada
Collaborators
East Elgin Family Health Team

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
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.
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
Keywords
HbA1C, virtual care, blood glucose, physical activity, HIIT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
One of the investigators, Justine Horne, will be blinded to group allocations.
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Population-Based Physical Activity (PA) Advice
Arm Type
Active Comparator
Arm Description
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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
Arm Title
High-Intensity Interval Training Physical Activity (PA) Advice
Arm Type
Experimental
Arm Description
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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
Intervention Type
Other
Intervention Name(s)
High-Intensity Interval Training Physical Activity (PA) Advice
Intervention Description
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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
Intervention Type
Other
Intervention Name(s)
Population-Based Physical Activity (PA) Advice
Intervention Description
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 Justine Horne who is a lifestyle coach and co-investigator on this trial. If participants have questions about their PA protocol, Justine will respond to these over the phone.
Primary Outcome Measure Information:
Title
Change in HbA1C
Description
Glycosylated Hemoglobin measured at lab
Time Frame
3-month and 6-month follow-up
Secondary Outcome Measure Information:
Title
Weight
Description
self-reported by participants using home scale
Time Frame
3-month and 6-month follow-up
Title
Physical Activity (minutes per week)
Description
self-reported by participants using the log books designed for this study
Time Frame
3-month and 6-month follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Fernando, MD
Phone
519-773-3715
Ext
111
Email
mfernando@eefht.ca
Facility Information:
Facility Name
East Elgin Family Health Team
City
Aylmer
State/Province
Ontario
ZIP/Postal Code
N5H1K9
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Fernando
Email
mfernando@eefht.ca

12. IPD Sharing Statement

Learn more about this trial

Family Health Team High-Intensity Interval Training

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