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| Name | Class |
|---|---|
| McMaster University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Exercise Snacks | Experimental | Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week. |
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| Placebo Exercise | Active Comparator | Low-intensity stretching exercises performed 4 times per day on at least 5 days per week. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise Snacks | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| 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) |
| 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 |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in glycated hemoglobin measured before and after the 12-week intervention | Glycated hemoglobin (A1c) at baseline and after 12 weeks. | 0-12 weeks |
| Change in fasting glucose measured before and after the 12-week intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jonathan P Little, PhD | Contact | 250.807.9876 | jonathan.little@ubc.ca |
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Little, PhD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of British Columbia Okanagan | Recruiting | Kelowna | British Columbia | V1V 3G1 | Canada |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| Placebo Exercise | 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. |
|
Fasting glucose measured at baseline and after the 12-week intervention.
| 0-12 weeks |
| 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 |
| 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 |
| Change in cardiorespiratory fitness measured before and after the 12-week intervention | Submaximal YMCA cycle ergometer test to estimate VO2 peak. | 0-12 weeks |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Change in plasma inflammatory cytokines measured before and after the 12-week intervention | TNF-α, IL-6, IL-10, CRP | 0-12 weeks |
| 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 |
| 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 |
| D004700 | Endocrine System Diseases |