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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Type2diabetes
• Intervention / Treatment: Behavioral: high intensity body-weight circuit; Behavioral: traditional exercise intervention (TEI)

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Brian Kliszczewicz, Ph.D.; Phone Number: 315-415-6609; Email: Bkliszcz@kennesaw.edu

Study Locations

• United States
  • Georgia
    • Kennesaw, Georgia, United States, 30144
      • Recruiting
      • Kennesaw State Univeristy
      • Contact: Brian Kliszczewicz, Ph.D.; Phone Number: 315-415-6609; Email: Bkliszcz@kennesaw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 60 years (Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high intensity body-weight circuit (HIBC); 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; 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.
Active Comparator: 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.	Behavioral: traditional exercise intervention (TEI); 150 min a week of moderate aerobic exercise

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Kennesaw State University

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2022
• Primary Completion (Estimated): September 1, 2024
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: September 23, 2022
• First Submitted That Met QC Criteria: October 4, 2022
• First Posted (Actual): October 7, 2022

Study Record Updates

• Last Update Posted (Actual): August 2, 2023
• Last Update Submitted That Met QC Criteria: August 1, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Exercise
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Body Weight
• Other Study ID Numbers: KennesawSU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No