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

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ClinicalTrials.gov Identifier: NCT02707380
Recruitment Status : Completed
First Posted : March 14, 2016
Last Update Posted : March 31, 2016
Sponsor:
Information provided by (Responsible Party):
NYU Langone Health

Study Description
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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 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
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 : March 2015
Actual Primary Completion Date : March 2016
Actual Study Completion Date : March 2016

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Arms and Interventions
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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
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Primary Outcome Measures :
  1. Comparison of Stress measured by change in heart rate [ Time Frame: Baseline, One Year, 2 Years ]
  2. Leg strength measured by assessing maximum weight subject can press one time on a leg press machine [ Time Frame: up to 2 years ]
  3. Paired T-test to compare test-retest Perceived exertion [ Time Frame: up to 2 years ]
  4. Paired T-test to compare test-retest Perceived dyspnea [ Time Frame: up to 2 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02707380


Locations
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United States, New York
New York University School of Medicine
New York, New York, United States, 10016
Sponsors and Collaborators
NYU Langone Health
Investigators
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Principal Investigator: Francois Haas, MD New York University Medical School
More Information
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Responsible Party: NYU Langone Health
ClinicalTrials.gov Identifier: NCT02707380    
Other Study ID Numbers: 14-01994
First Posted: March 14, 2016    Key Record Dates
Last Update Posted: March 31, 2016
Last Verified: March 2016
Additional relevant MeSH terms:
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Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 2
 Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases