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The 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
NYU Langone Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Type 2 Diabetes (T2DM)

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept 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.

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

First Posted
February 22, 2016
Last Updated
March 29, 2016
Sponsor
NYU Langone Health
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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

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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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