NCT04515992

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

August 11, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 17, 2020

Completed
Last Updated

August 17, 2020

Status Verified

August 1, 2020

Enrollment Period

6 months

First QC Date

August 11, 2020

Last Update Submit

August 13, 2020

Conditions

Outcome Measures

Primary Outcomes (1)

  • Change from baseline of HbA1c

    glycosylated hemoglobin, marker of approximate three month blood glucose environment

    16 weeks

Study Arms (1)

High Intensity Body-weight Circuit (HIBC)

EXPERIMENTAL

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.

Behavioral: High Intensity Body-weight Circuit Training (HIBC)

Interventions

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.

High Intensity Body-weight Circuit (HIBC)

Eligibility Criteria

Age45 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of Type 2 Diabetes of at least 1 year
  • hemoglobin A1c level between 6.0% and 10%

You may not qualify if:

  • Currently engaging in a physical activity
  • Currently taking exogenous insulin
  • Undertaking a regiment or lifestyle modification intervention.
  • Cardiovascular or Pulmonary diseases.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kennesaw State University

Kennesaw, Georgia, 30144-2381, United States

Location

Study Officials

  • Brian Kliszczewicz, PhD

    Kennesaw State University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 11, 2020

First Posted

August 17, 2020

Study Start

March 1, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

August 17, 2020

Record last verified: 2020-08

Locations