Efficacy of Exercise Snacks in Real-World Settings in Individuals Living With Type 2 Diabetes

Last updated: May 6, 2024
Sponsor: University of British Columbia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Diabetes Prevention

Diabetes Mellitus, Type 2

Diabetes And Hypertension

Treatment

Placebo Exercise

Exercise Snacks

Clinical Study ID

NCT06407245
H24-03417
  • Ages 30-75
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 perweek).
  4. Body mass index: 18.5-40 kg/m2.
  5. Taking ≤3 glucose-lowering medications (excluding insulin) and stable dose for > 6months.
  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, ifapplicable, consultation with a health care provider or Qualified ExerciseProfessional.
  10. Access to a computer, tablet or smartphone for intervention delivery and tracking.
  11. Ability to read and write in English.

Exclusion

Exclusion Criteria:

  1. Chronic musculoskeletal condition or recent (within 2 years) cardiovascular eventpreventing 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 atypicalblood 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 preventexercise 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 studyprocedures 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., exogenousketones).
  11. Currently have diabetic ulcers, peripheral vascular disease, or diabetic neuropathythat will prevent participation in exercise.
  12. Currently participating in another clinical trial that interferes with the studyprocedures.
  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 havingneurological symptoms consistent with neuroglycopenia and required assistance intreatment by a second party).

Study Design

Total Participants: 80
Treatment Group(s): 2
Primary Treatment: Placebo Exercise
Phase:
Study Start date:
April 20, 2024
Estimated Completion Date:
July 19, 2025

Study 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.

Connect with a study center

  • University of British Columbia Okanagan

    Kelowna, British Columbia V1V 3G1
    Canada

    Active - Recruiting

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