High Intensity Body-weight Circuit Training Feasibility and Efficacy for in Middle Aged Persons With Type 2 Diabetes

Study Overview
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Brief Summary
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This research study proposes to quantify the efficacy of the novel high intensity body-weight circuit (HIBC) training intervention on metabolic profile, body composition, and health related fitness exercise in middle aged persons with type-2 diabetes (T2DM); and secondarily, compare these outcomes to that of a traditional exercise intervention (TEI). This research project is extremely relevant to public health, in that prevalence of T2DM continues to rise on a national and global scale, placing a heavy economic cost on both the healthcare industry and the individual patient in an age-dependent fashion. Results of this study may provide an effective and appealing alternative exercise intervention for cardiometabolic disease management in adults with T2DM, and have significant clinical and public health applications.

Official Title
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High Intensity Body-weight Circuit Training Feasibility and Efficacy for Improving Metabolic Profile, Body Composition, and Health-Related Fitness in Middle Aged Persons With Type 2 Diabetes

Conditions
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Type2diabetes

Intervention / Treatment
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* Behavioral: high intensity body-weight circuit
* Behavioral: traditional exercise intervention (TEI)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Recent diagnosed of type 2 diabetes (T2DM) (within a year) HbA1c between 6% and 8% Non-insulin dependent No medicinal treatment Not currently undergoing a physical activity program in the last six months Received written medical clearance from overseeing physician Willingness to be randomized to either intervention group Exclusion Criteria: Those who have undergone any revascularization procedure Diagnosed with or symptomatic of any renal, pulmonary, or cardiovascular disease (CVD) Diagnosed cognitive dysfunction Current smoker

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high intensity body-weight circuit (HIBC)<br>HIBC Exercise Protocol- circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10), and modified push-ups (5). The exercise sessions will involve repeating a series of repetitions of each movement in sequence, and completing as many sequences as possible in good form in the time allotted for the exercise (initially, 5 minutes). Three sessions per week will be completed at home. After three weeks of training, participants will be asked to add a fourth session each week. Initially, the HIBC sessions will be five minutes long, and the duration of the sessions will increase by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session (warm up not included in this timing) as early as the eighth week of training. Session duration will be capped at 10-minutes. | Behavioral: high intensity body-weight circuit<br>* Bodyweight and suspension training equipment (TRX® Fit System) with modified movements. Modified Squats: participants will be instructed to hold the handles of the band with arms extended, participants will then lean back in a standing position and perform a squat within a comfortable range of motion while weight is being distributed to the band. Modified Rows: participants will grab the bands with arms and legs extended. They will find a comfortable angle by which to perform a row (pulling the handles to the rib cage) with arms at a 45-degree angle. Modified Push-Ups: perform push-ups on their knees with a flat back and hands underneath their shoulders. They will be instructed to lower their chest towards the ground in a controlled manner and as far as comfort will allow them. Modified Crunches: participants will lay on their back with feet approximately 8-10 inches from their buttocks, and asked to lift their shoulders slightly off the ground.<br>|
| Active Comparator: traditional exercise intervention (TEI)<br>TEI Protocol- The American College of Sports Medicine (ACSM) and the American Diabetes Association (ADA) joint position stand on exercise prevention for T2DM recommends participants undertake at least 150 min/week of moderate to vigorous activity in high-risk adults 5,13. Therefore, this intervention will initially consist of three sessions per week of 40 minutes of continuous physical activity, and increase to a fourth weekly session following the third week. The TEI modality will consist of walking exercise at a moderate intensity of 40- 60% heart rate reserve (([maximal heart rate - resting heart rate] x 0.4-0.6) + resting heart rate). Participants will continue this protocol for 16-weeks. | Behavioral: traditional exercise intervention (TEI)<br>* 150 min a week of moderate aerobic exercise<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c change within participant | HbA1c (glycosylated Hemoglobin) indicates what the blood glucose environment was like for that past 3-months. This is the average life span of a red blood cell. High levels of blood glucose over a 3 month period lead to high HbA1c and vis versa. HbA1c can change as early as 14 weeks. | Pre and post 16-week intervention | 
| Oral Glucose Tolerance Test change within participant | Glucose and Insulin response to bolus amount of glucose beverage | Pre and post 16-week intervention | 
| Body Composition change within participant | Fat mass and lean mass | Pre and post 16-week intervention | 
| Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant | sub maximal treadmill endurance test | Pre and post 16-week intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare primary outcome measures 1 through 4 between the HIBC to TEI interventions | Evaluate the effectiveness of the HIBC compared to TEI by comparing the primary outcomes 1 through 4 (which evaluate change within the participant in each group) | Pre and post 16-week intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Exercise