- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04515992
High Intensity Body-weight Circuit Training in Type 2 Diabetics
August 13, 2020 updated by: Kennesaw State University
Feasibility of Minimal Dose High Intensity Body-weight Circuit Training in Type 2 Diabetics
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
6
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Georgia
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Kennesaw, Georgia, United States, 30144-2381
- Kennesaw State University
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
45 years to 65 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
EXPERIMENTAL: High Intensity Body-weight Circuit (HIBC)
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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change from baseline of HbA1c
Time Frame: 16 weeks
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glycosylated hemoglobin, marker of approximate three month blood glucose environment
|
16 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Brian Kliszczewicz, PhD, Kennesaw State University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
March 1, 2018
Primary Completion (ACTUAL)
September 1, 2018
Study Completion (ACTUAL)
September 1, 2018
Study Registration Dates
First Submitted
August 11, 2020
First Submitted That Met QC Criteria
August 13, 2020
First Posted (ACTUAL)
August 17, 2020
Study Record Updates
Last Update Posted (ACTUAL)
August 17, 2020
Last Update Submitted That Met QC Criteria
August 13, 2020
Last Verified
August 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- # 18-348
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
IPD Plan Description
Upon publication of research, data will be made publicly available
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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