NCT02707380

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2015

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
8 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2016

Completed
13 days until next milestone

First Posted

Study publicly available on registry

March 14, 2016

Completed
Last Updated

March 31, 2016

Status Verified

March 1, 2016

Enrollment Period

1 year

First QC Date

February 22, 2016

Last Update Submit

March 29, 2016

Conditions

Type 2 Diabetes (T2DM)Cardiovascular Disease

Outcome Measures

Primary Outcomes (4)

  • 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

Study Arms (2)

Group 1 Resistance Training Group

ACTIVE COMPARATOR

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

Group 2 Standard of Care

ACTIVE COMPARATOR

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

Interventions

Resistance TrainingOTHER

7 muscle-strengthening exercises using body weight resistance and elastic resistance bands

Group 1 Resistance Training Group
Standard of CareOTHER

3 exercises that do not include these 7 muscle-strengthening exercises

Group 2 Standard of Care

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Patients with orthopedic or neurological limitations that would prevent them from participating in the resistance training program or monitored exercise sessions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

New York University School of Medicine

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Cardiovascular Diseases

Interventions

Resistance TrainingStandard of Care

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological PhenomenaQuality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Officials

  • Francois Haas, MD

    New York University Medical School

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 14, 2016

Study Start

March 1, 2015

Primary Completion

March 1, 2016

Study Completion

March 1, 2016

Last Updated

March 31, 2016

Record last verified: 2016-03

Locations

US(1)