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

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06407245
• Other study ID #: H24-03417
• Status: Recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: July 19, 2025

Study information

• Verified date: May 2024
• Source: University of British Columbia
• Contact: Jonathan P Little, PhD
• Phone: 250.807.9876
• Email: jonathan.little[@]ubc.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 19, 2025
• Est. primary completion date: July 19, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 75 Years

Eligibility

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).

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	University of British Columbia Okanagan	Kelowna	British Columbia

Sponsors (2)

Lead Sponsor	Collaborator
University of British Columbia	McMaster University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine the number of individuals living with type 2 diabetes that are eligible to participate in the trial	The number of participants approached and reasons for not joining the study.	NA (recruitment period)
Primary	Determine the number of eligible individuals who would be willing to take part in this trial	The number of patients who enrol.	NA (recruitment period)
Primary	Determine the number and percentage of participants retained after the 12-week intervention	Number and percentage of patients who drop-out and reasons.	after the 12-week intervention
Primary	Determine the number of one-minute exercise bouts performed during the 12-week intervention	Number of exercise bouts performed each week of the intervention.	during the 12 weeks
Secondary	Change in glycated hemoglobin measured before and after the 12-week intervention	Glycated hemoglobin (A1c) at baseline and after 12 weeks.	0-12 weeks
Secondary	Change in fasting glucose measured before and after the 12-week intervention	Fasting glucose measured at baseline and after the 12-week intervention.	0-12 weeks
Secondary	Change in fasting insulin measured before and after the 12-week intervention	Fasting insulin measured at baseline and after the 12-week intervention	0-12 weeks
Secondary	Change in 24h glucose concentration	Average of 24h glucose value measured with continuous glucose monitor at week 0 and week 11 of the intervention.	before (week 0; before the intervention) and week 11 of the intervention
Secondary	Change in cardiorespiratory fitness measured before and after the 12-week intervention	Submaximal YMCA cycle ergometer test to estimate VO2 peak.	0-12 weeks
Secondary	Change in lower body muscular endurance measured before and after the 12-week intervention	The 30-second sit-to-stand pre- and post-intervention.	0-12 weeks
Secondary	Change in upper body maximal strength measured before and after the 12-week intervention	Grip strength test using a hand dynamometer pre- and post-intervention	0-12 weeks
Secondary	Change in body composition measured before and after the 12-week intervention	Waist circumference, weight and body mass index assessed pre- and post- intervention.	0-12 weeks
Secondary	Change in blood pressure measured before and after the 12-week intervention	Seated systolic and diastolic blood pressure measured before and after the 12-week intervention.	0-12 weeks
Secondary	Change in blood lipid profile measured before and after the 12-week intervention	Total cholesterol, high-density lipoprotein (HDL) cholesterol, Non-HDL cholesterol, low-density lipoprotein (LDL) cholesterol, and Triglycerides.	0-12 weeks
Secondary	Change in complete blood count measured before and after the 12-week intervention	Red blood cells, white blood cells, haemoglobin, haematocrit, and platelet.	0-12 weeks
Secondary	Change in plasma inflammatory cytokines measured before and after the 12-week intervention	TNF-a, IL-6, IL-10, CRP	0-12 weeks
Secondary	Change in health-related quality of life measured before and after the 12-week intervention	Euro Quality of Life 5 Dimension 5 Level (EQ-5D-5L) questionnaire pre- and post-intervention	0-12 weeks
Secondary	Changes in diabetes distress measured before and after the intervention 12-week intervention	Diabetes Distress Scale (DDS) questionnaire pre- and post-intervention	0-12 weeks