Clinical trial NCT04109235: Family Health Team High-Intensity Interval Training
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Keywords: HbA1C
virtual care
blood glucose
physical activity
HIIT
Lead sponsor: Western University, Canada
Sponsor class: OTHER
Collaborators: name: East Elgin Family Health Team
First posted: 2019-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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

Primary outcomes:
measure: Change in HbA1C
timeFrame: 3-month and 6-month follow-up
Secondary outcomes:
measure: Weight
timeFrame: 3-month and 6-month follow-up
measure: Physical Activity (minutes per week)
timeFrame: 3-month and 6-month follow-up
Other outcomes:
Locations:
city: Aylmer
country: Canada
facility: East Elgin Family Health Team
state: Ontario
Study officials:
References: