An interventional study of Exercise Snacks and Placebo Exercise in Type 2 Diabetes, sponsored by University of British Columbia. Status unknown at 1 site in Canada. Open to participants aged 30 Years to 75 Years. Per ClinicalTrials.gov, last updated 2024-05-09.
Sponsored by University of British Columbia · Not applicable, Interventional, and Treatment
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.
9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.
This study's planned enrollment of 80 is close to the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of British Columbia is the lead sponsor of 1,335 studies on the registry; 256 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 1 (17%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Vigorous-intensity bodyweight exercises performed 4 times per day on at least 5 days per week.
Other: Exercise Snacks
Low-intensity stretching exercises performed 4 times per day on at least 5 days per week.
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.
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.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: during the 12 weeks
Change in glycated hemoglobin measured before and after the 12-week intervention
Glycated hemoglobin (A1c) at baseline and after 12 weeks.
Time frame: 0-12 weeks
Change in fasting glucose measured before and after the 12-week intervention
Fasting glucose measured at baseline and after the 12-week intervention.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 0-12 weeks
Change in plasma inflammatory cytokines measured before and after the 12-week intervention
TNF-α, IL-6, IL-10, CRP
Time frame: 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
Time frame: 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
Time frame: 0-12 weeks
Plan to share: No
Started Apr 2024 (actual). Primary completion is estimated for Jul 2025, 14 months after the start.
Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 14 months is below that.
Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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University of British Columbia →