High Intensity Body-weight Circuit Training in Type 2 Diabetics
Primary Purpose
Type2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
High Intensity Body-weight Circuit Training (HIBC)
Sponsored by
About this trial
This is an interventional treatment trial for Type2 Diabetes
Eligibility Criteria
Inclusion Criteria:
- Clinical diagnosis of Type 2 Diabetes of at least 1 year
- hemoglobin A1c level between 6.0% and 10%
Exclusion Criteria:
- Currently engaging in a physical activity
- Currently taking exogenous insulin
- Undertaking a regiment or lifestyle modification intervention.
- Cardiovascular or Pulmonary diseases.
Sites / Locations
- Kennesaw State University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
High Intensity Body-weight Circuit (HIBC)
Arm Description
The at home HIBC intervention program involved the use of both bodyweight and suspension training equipment (TRX® Fit System) with modified movements. The TRX® system was used to modify squats and rows while attached to the top of a door frame.
Outcomes
Primary Outcome Measures
Change from baseline of HbA1c
glycosylated hemoglobin, marker of approximate three month blood glucose environment
Secondary Outcome Measures
Full Information
NCT ID
NCT04515992
First Posted
August 11, 2020
Last Updated
August 13, 2020
Sponsor
Kennesaw State University
1. Study Identification
Unique Protocol Identification Number
NCT04515992
Brief Title
High Intensity Body-weight Circuit Training in Type 2 Diabetics
Official Title
Feasibility of Minimal Dose High Intensity Body-weight Circuit Training in Type 2 Diabetics
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
March 1, 2018 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
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
5. Study Description
Brief Summary
Exercise has been shown to be effective at improving fitness, as well as markers of glucose tolerance and control, in persons with type 2 diabetes. Recently, several investigations have demonstrated that improvements are realized by patients with high intensity interval exercise which is characterized by periods of vigorous exercise alternated by periods of moderate exercise. Typical interval training sessions require significantly less time to complete than traditional modes of exercise wherein moderate intensity activity is sustained for some time. This may be especially beneficial to those with type 2 diabetes, as lack of time is a frequently cited reason for not engaging in regular exercise. Bodyweight circuit training carries the potential to similarly improve health and metabolic function in persons with type 2 diabetes, and may do so with even a smaller accumulation of exercise because this type of exercise involves a greater percentage of the trainee's muscle mass compared with common forms of interval training (e.g., treadmill or cycle exercise). The purpose of this study is to quantify the effects of 3-4 sessions per week of bodyweight circuit training sustained for 5-10 minutes per session on health-related physical fitness and glucose tolerance/control in people with type 2 diabetes.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
6 (Actual)
8. Arms, Groups, and Interventions
Arm Title
High Intensity Body-weight Circuit (HIBC)
Arm Type
Experimental
Arm Description
The at home HIBC intervention program involved the use of both bodyweight and suspension training equipment (TRX® Fit System) with modified movements. The TRX® system was used to modify squats and rows while attached to the top of a door frame.
Intervention Type
Behavioral
Intervention Name(s)
High Intensity Body-weight Circuit Training (HIBC)
Intervention Description
HIBC Exercise Protocol- The HIBC circuit repetition and order is as follows: modified squats (10 repetitions), modified rows (5 repetitions), crunches (10 repetitions), and modified push-ups (5 repetitions). The exercise sessions involved 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). Participants were instructed to complete three sessions per week and documented the number of cycles completed. After 3 weeks of consistent training, participants were asked to add a 4th session each week as tolerated. Initially, the HIBC sessions were 5 minutes long, and the duration of the sessions were increased by one minute each week as tolerated beginning in week four, peaking at 10-minutes per session as early as the eighth week of training. Session duration was capped at 10 minutes.
Primary Outcome Measure Information:
Title
Change from baseline of HbA1c
Description
glycosylated hemoglobin, marker of approximate three month blood glucose environment
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Clinical diagnosis of Type 2 Diabetes of at least 1 year
hemoglobin A1c level between 6.0% and 10%
Exclusion Criteria:
Currently engaging in a physical activity
Currently taking exogenous insulin
Undertaking a regiment or lifestyle modification intervention.
Cardiovascular or Pulmonary diseases.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Brian Kliszczewicz, PhD
Organizational Affiliation
Kennesaw State University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kennesaw State University
City
Kennesaw
State/Province
Georgia
ZIP/Postal Code
30144-2381
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
IPD Sharing Plan Description
Upon publication of research, data will be made publicly available
Learn more about this trial
High Intensity Body-weight Circuit Training in Type 2 Diabetics
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