- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04109235
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
Study Overview
Status
Conditions
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Michael Fernando, MD
- Phone Number: 111 519-773-3715
- Email: mfernando@eefht.ca
Study Locations
-
-
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
Accepts Healthy Volunteers
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
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.
|
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.
|
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
Time Frame: 3-month and 6-month follow-up
|
Glycosylated Hemoglobin measured at lab
|
3-month and 6-month follow-up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight
Time Frame: 3-month and 6-month follow-up
|
self-reported by participants using home scale
|
3-month and 6-month follow-up
|
Physical Activity (minutes per week)
Time Frame: 3-month and 6-month follow-up
|
self-reported by participants using the log books designed for this study
|
3-month and 6-month follow-up
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 111930
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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