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

Sponsor

NYU Langone Health (Other)

Overall Status

Completed

CT.gov ID

NCT02707380

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Type 2 Diabetes (T2DM) Cardiovascular Disease	Other: Resistance Training Other: Standard of Care	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

3 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Supportive Care

Official Title:

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

Study Start Date :

Mar 1, 2015

Actual Primary Completion Date :

Mar 1, 2016

Actual Study Completion Date :

Mar 1, 2016

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

NYU Langone Health

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

NYU Langone Health

ClinicalTrials.gov Identifier:

NCT02707380

Other Study ID Numbers:

14-01994

First Posted:

Mar 14, 2016

Last Update Posted:

Mar 31, 2016

Last Verified:

Mar 1, 2016

Additional relevant MeSH terms:

Cardiovascular Diseases

Diabetes Mellitus

Diabetes Mellitus, Type 2

Study Results

No Results Posted as of Mar 31, 2016