Clinical trial NCT06407245: Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes
Official title: Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: McMaster University
First posted: 2024-05-09
Enrollment: 80
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To conduct a pilot randomized control trial to determine the feasibility of a 12-week, technology-enabled exercise snacks intervention in adults living with type 2 diabetes in a real-world setting. We will also assess preliminary efficacy based on measures of glycemic control and fitness.

Detailed description: Participants will be randomized into an Exercise Snacks or a Placebo Exercise group for 12 weeks. The former will involve bodyweight exercises performed with vigorous effort and the latter will involve low-intensity exercises. Following baseline testing, individualized interventions will be delivered at home or work via customized mobile application ("app") or web platform. Participants will be instructed to perform a minimum of 4 isolated bouts of prescribed exercises per day on at least 5 days per week. Each bout will be one minute in duration. The interventions will be individualized and consider exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues), and be adaptable to multiple environments (e.g., home, work). To facilitate this, participants will have a pre-intervention meeting wherein any physical limitations will be documented, and a research assistant will discuss the prescribed intervention and determine when and where the participants will plan to perform their exercises. After 12 weeks, participants will be asked to return to the lab for follow-up testing.

Eligibility criteria: Inclusion Criteria:

1. Aged 30-75 years.
2. Have physician-diagnosed type 2 diabetes.
3. Physically inactive (performing \<150 min moderate-to-vigorous physical activity per week).
4. Body mass index: 18.5-40 kg/m2.
5. Taking ≤3 glucose-lowering medications (excluding insulin) and stable dose for \> 6 months.
6. Taking ≤2 commonly prescribed cardiovascular medications (e.g., statins, antihypertensive).
7. HbA1c ≤8.5%.
8. Able to maintain current physical activity patterns during the study.
9. Cleared to engage in physical activity using the Get Active Questionnaire and, if applicable, consultation with a health care provider or Qualified Exercise Professional.
10. Access to a computer, tablet or smartphone for intervention delivery and tracking.
11. Ability to read and write in English.

Exclusion Criteria:

1. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular event preventing participation in exercise.
2. Lack of internet access.
3. Angina upon exertion assessed by the Rose Angina Questionnaire.
4. Prescribed beta-blockers that can compromise the validity of heart rate measurements. during the submaximal exercise test.
5. Have uncontrolled high blood pressure (hypertension; ≥ 160/90 mmHg) or an atypical blood pressure or pulse rate at rest or during exercise as determined by a physician.
6. Have a scheduled surgical procedure within the next 3-4 months that would prevent exercise participation.
7. Currently diagnosed with a cardiac or pulmonary disease (e.g., angina, arrythmia, exercise-induced bronchospasm) that would prevent exercise participation.
8. Have a psychiatric disorder that could prevent you from completing the study procedures or visits.
9. Have donated more than 0.5 L of blood within the last 4 weeks.
10. Currently following an extreme diet (e.g., very low carbohydrate/calorie, ketogenic) or taking dietary/nutritional supplements that impact glucose control (e.g., exogenous ketones).
11. Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathy that will prevent participation in exercise.
12. Currently participating in another clinical trial that interferes with the study procedures.
13. Currently on dialysis.
14. Currently pregnant or planning on becoming pregnant during the intervention (i.e., within the next 4 months).
15. Have had an episode of severe hypoglycemia in the past 6 months (defined as having neurological symptoms consistent with neuroglycopenia and required assistance in treatment by a second party).

Primary outcomes:
measure: Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial
timeFrame: NA (recruitment period)
measure: Determine the number of eligible individuals who would be willing to take part in this trial
timeFrame: NA (recruitment period)
measure: Determine the number and percentage of participants retained after the 12-week intervention
timeFrame: after the 12-week intervention
measure: Determine the number of one-minute exercise bouts performed during the 12-week intervention
timeFrame: during the 12 weeks
Secondary outcomes:
measure: Change in glycated hemoglobin measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in fasting glucose measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in fasting insulin measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in 24h glucose concentration
timeFrame: before (week 0; before the intervention) and week 11 of the intervention
measure: Change in cardiorespiratory fitness measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in lower body muscular endurance measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in upper body maximal strength measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in body composition measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in blood pressure measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in blood lipid profile measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in complete blood count measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in plasma inflammatory cytokines measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Change in health-related quality of life measured before and after the 12-week intervention
timeFrame: 0-12 weeks
measure: Changes in diabetes distress measured before and after the intervention 12-week intervention
timeFrame: 0-12 weeks
Other outcomes:
Locations:
city: Kelowna
country: Canada
facility: University of British Columbia Okanagan
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Jonathan Little, PhD
role: PRINCIPAL_INVESTIGATOR
References: