Recruiting

Exercise Snacks

Sponsor:

University of British Columbia

Code:

NCT06407245

Conditions

Type 2 Diabetes

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

Interventions

Exercise Snacks

Placebo Exercise

Study Details

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.

Conditions

Type 2 Diabetes

Study ID

NCT06407245

Start date

Apr 20, 2024

Status verified date

May, 2024

Completion date

Jul 19, 2025

Anticipated

Primary completion date

Jul 19, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 30 - 70+

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

80 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Exercise Snacks

Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week.

active comparator: Placebo Exercise

Low-intensity stretching exercises performed 4 times per day on at least 5 days per week.

Interventions

Exercise Snacks

The "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application.

Placebo Exercise

The "movement breaks" will be individualized to exercise preferences and physical abilities (e.g., fitness, musculoskeletal issues) and adaptable to multiple environments (e.g., home, work) delivered via mobile phone application.

Primary outcome measure

  • Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial [ Time Frame: NA (recruitment period) ]
  • Determine the number of eligible individuals who would be willing to take part in this trial [ Time Frame: NA (recruitment period) ]
  • Determine the number and percentage of participants retained after the 12-week intervention [ Time Frame: after the 12-week intervention ]
  • Determine the number of one-minute exercise bouts performed during the 12-week intervention [ Time Frame: during the 12 weeks ]

Central Contacts and Locations

Central contacts

Locations

University of British Columbia Okanagan

Recruiting

Kelowna, British Columbia, Canada, V1V 3G1

Contacts

More Information

Sponsor

University of British Columbia

Last update posted

May 9, 2024

Last verified

May, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-05-09.