Back to resultsThe Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Primary Purpose
Type 2 Diabetes (T2DM), Cardiovascular Disease
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Resistance Training
Standard of Care
Sponsored by
About this trial
This is an interventional supportive care trial for Type 2 Diabetes (T2DM)
Eligibility 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.
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Group 1 Resistance Training Group
Group 2 Standard of Care
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
Comparison of Stress measured by change in heart rate
Leg strength measured by assessing maximum weight subject can press one time on a leg press machine
Paired T-test to compare test-retest Perceived exertion
Paired T-test to compare test-retest Perceived dyspnea
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02707380
Brief Title
The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Official Title
The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
Study Type
Interventional
2. Study Status
Record Verification Date
March 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes (T2DM), Cardiovascular Disease
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group 1 Resistance Training Group
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group 2 Standard of Care
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Resistance Training
Intervention Description
7 muscle-strengthening exercises using body weight resistance and elastic resistance bands
Intervention Type
Other
Intervention Name(s)
Standard of Care
Intervention Description
3 exercises that do not include these 7 muscle-strengthening exercises
Primary Outcome Measure Information:
Title
Comparison of Stress measured by change in heart rate
Time Frame
Baseline, One Year, 2 Years
Title
Leg strength measured by assessing maximum weight subject can press one time on a leg press machine
Time Frame
up to 2 years
Title
Paired T-test to compare test-retest Perceived exertion
Time Frame
up to 2 years
Title
Paired T-test to compare test-retest Perceived dyspnea
Time Frame
up to 2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Francois Haas, MD
Organizational Affiliation
New York University Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
The Effectiveness of Resistance Training on Glycemic Control for Patients With Type 2 Diabetes in Cardiac Rehabilitation
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