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

Primary Purpose

Type2diabetes

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
high intensity body-weight circuit
traditional exercise intervention (TEI)
Sponsored by
Kennesaw State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2diabetes focused on measuring Exercise

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kennesaw State UniveristyRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

high intensity body-weight circuit (HIBC)

traditional exercise intervention (TEI)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
Oral Glucose Tolerance Test change within participant
Glucose and Insulin response to bolus amount of glucose beverage
Body Composition change within participant
Fat mass and lean mass
Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant
sub maximal treadmill endurance test

Secondary Outcome Measures

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)

Full Information

First Posted
September 23, 2022
Last Updated
August 1, 2023
Sponsor
Kennesaw State University
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1. Study Identification

Unique Protocol Identification Number
NCT05571384
Brief Title
High Intensity Body-weight Circuit Training Feasibility and Efficacy for in Middle Aged Persons With Type 2 Diabetes
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 26, 2022 (Actual)
Primary Completion Date
September 1, 2024 (Anticipated)
Study Completion Date
January 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kennesaw State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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); 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2diabetes
Keywords
Exercise

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
84 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
high intensity body-weight circuit (HIBC)
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional exercise intervention (TEI)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
high intensity body-weight circuit
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
traditional exercise intervention (TEI)
Intervention Description
150 min a week of moderate aerobic exercise
Primary Outcome Measure Information:
Title
HbA1c change within participant
Description
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.
Time Frame
Pre and post 16-week intervention
Title
Oral Glucose Tolerance Test change within participant
Description
Glucose and Insulin response to bolus amount of glucose beverage
Time Frame
Pre and post 16-week intervention
Title
Body Composition change within participant
Description
Fat mass and lean mass
Time Frame
Pre and post 16-week intervention
Title
Estimated VO2max (oxygen consumption), aerobic exercise capacity change within participant
Description
sub maximal treadmill endurance test
Time Frame
Pre and post 16-week intervention
Secondary Outcome Measure Information:
Title
Compare primary outcome measures 1 through 4 between the HIBC to TEI interventions
Description
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)
Time Frame
Pre and post 16-week intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brian Kliszczewicz, Ph.D.
Phone
315-415-6609
Email
Bkliszcz@kennesaw.edu
Facility Information:
Facility Name
Kennesaw State Univeristy
City
Kennesaw
State/Province
Georgia
ZIP/Postal Code
30144
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Brian Kliszczewicz, Ph.D.
Phone
315-415-6609
Email
Bkliszcz@kennesaw.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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

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