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

NCT ID: NCT06407245

Last Updated: 2024-05-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-07-19

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.

Conditions

Type 2 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Exercise Snacks

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

Group Type: EXPERIMENTAL

Exercise Snacks

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

Placebo Exercise

Intervention Type: OTHER

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.

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.

Intervention Type: OTHER

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.

Intervention Type: OTHER

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).

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jonathan Little

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jonathan Little, PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

University of British Columbia Okanagan

Kelowna, British Columbia, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Jonathan P Little, PhD

Role: CONTACT

jonathan.little@ubc.ca

250.807.9876

Facility Contacts

Jonathan Little, PhD

Role: primary

jonathan.little@ubc.ca

2508079876

Role: backup

jonathan.little@ubc.ca

2508079876

Other Identifiers

H24-03417

Identifier Type: -

Identifier Source: org_study_id