The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation

March 29, 2016 updated by: NYU Langone Health
This study is designed to investigate the effect of a structured resistance training program on glycemic control, measured by hemoglobin A1c (glycated hemoglobin), in patients with type 2 diabetes (T2DM) who are enrolled in outpatient cardiac rehabilitation. The investigator will compare the experimental group receiving resistance training to a control group made of patients enrolled in outpatient cardiac rehabilitation and perform 3 aerobic exercise modalities during their sessions, which is the current standard of care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

3

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

  • United States
    • New York
      • New York, New York, United States, 10016
        • New York University School of Medicine

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

18 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis with T2DM and have been accepted for a standard outpatient cardiac rehabilitation program
  • Cognitively able to comprehend the information presented in the program
  • Cognitively able to give informed consent to participate in this study

Exclusion Criteria:

  • Patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group 1 Resistance Training Group
Participants will perform 3 exercises, one of which will be a series of 7 muscle-strengthening exercises using body weight resistance and elastic resistance bands + 36 sessions of a standard cardiac rehabilitation program consisting of monitored exercise, nutritional guidance, and heart-healthy lifestyle education three times weekly.
Other: Resistance Training
7 muscle-strengthening exercises using body weight resistance and elastic resistance bands
Active Comparator: Group 2 Standard of Care
Participants will perform 3 exercises that do not include the 7 muscle-strengthening exercises + 36 sessions of a standard cardiac rehabilitation program consisting of monitored exercise, nutritional guidance, and heart-healthy lifestyle education three times weekly.
Other: Standard of Care
3 exercises that do not include these 7 muscle-strengthening exercises

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Comparison of Stress measured by change in heart rate
Time Frame: Baseline, One Year, 2 Years
Baseline, One Year, 2 Years
Leg strength measured by assessing maximum weight subject can press one time on a leg press machine
Time Frame: up to 2 years
up to 2 years
Paired T-test to compare test-retest Perceived exertion
Time Frame: up to 2 years
up to 2 years
Paired T-test to compare test-retest Perceived dyspnea
Time Frame: up to 2 years
up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NYU Langone Health

Investigators

  • Principal Investigator: Francois Haas, MD, New York University Medical School

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

March 1, 2015

Primary Completion (Actual)

March 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

February 22, 2016

First Submitted That Met QC Criteria

March 11, 2016

First Posted (Estimate)

March 14, 2016

Study Record Updates

Last Update Posted (Estimate)

March 31, 2016

Last Update Submitted That Met QC Criteria

March 29, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-01994

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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