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

Not Applicable

Recruiting

• Conditions: Type2diabetes
• Interventions: Behavioral: traditional exercise intervention (TEI); Behavioral: high intensity body-weight circuit

• Registration Number: NCT05571384
• Lead Sponsor: Kennesaw State University

Brief Summary

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). 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-07-26
• Study First Submitted: 2022-09-23
• Study First Submitted QC: 2022-10-04
• Study First Posted: 2022-10-07
• Status Verified: 2025-03
• Last Update Submitted: 2025-03-25
• Last Update Posted: 2025-03-28
• Primary Completion: 2025-07-31
• Study Completion: 2025-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 42

Inclusion Criteria

• Recent diagnosed of type 2 diabetes (T2DM) (within a year) * HbA1c of 6% or higher

  • 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

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
traditional exercise intervention (TEI)	traditional exercise intervention (TEI)	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.
high intensity body-weight circuit (HIBC)	high intensity body-weight circuit	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.

Primary Outcome Measures

Name	Time	Method
HbA1c change within participant	Pre and post 16-week intervention	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.
Oral Glucose Tolerance Test change within participant	Pre and post 16-week intervention	Glucose and Insulin response to bolus amount of glucose beverage
Body Composition change within participant	Pre and post 16-week intervention	Fat mass and lean mass
Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant	Pre and post 16-week intervention	sub maximal treadmill endurance test

Trial Locations

Locations (1)

Kennesaw State Univeristy; 🇺🇸 Kennesaw, Georgia, United States