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

Cardiovascular Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02707380
• Other study ID #: 14-01994
• Status: Recruiting
• Phase: N/A
• First received: February 22, 2016
• Last updated: March 11, 2016
• Start date: March 2015
• Est. completion date: March 2017

Study information

• Verified date: March 2016
• Source: New York University School of Medicine
• Contact: Olanta Chandler, MD
• Email: bartoo02[@]nyumc.org
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: March 2017
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiovascular Disease
• Cardiovascular Diseases
• Diabetes Mellitus, Type 2
• Type 2 Diabetes (T2DM)

Intervention

Other:
• Resistance Training
7 muscle-strengthening exercises using body weight resistance and elastic resistance bands
• Standard of Care
3 exercises that do not include these 7 muscle-strengthening exercises

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of Stress measured by change in heart rate		Baseline, One Year, 2 Years	No
Primary	Leg strength measured by assessing maximum weight subject can press one time on a leg press machine		up to 2 years	No
Primary	Paired T-test to compare test-retest Perceived exertion		up to 2 years	No
Primary	Paired T-test to compare test-retest Perceived dyspnea		up to 2 years	No