HEARTS: Heart, Exercise, and Resistance Training Study

NCT00094250 | Withdrawn

• 2 other identifiers: 1272R01HL071567
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

This study is enrolling patients with congestive heart failure (CHF). The goal of the study is to see if one of two carefully monitored exercise programs can improve the ability of these patients to function and get about their activities.

Conditions

Cardiovascular Diseases; Heart Failure, Congestive; Heart Diseases

Outcome Measures

Primary Outcomes (1)

• Improvement in work capacity at anaerobic threshold (measured at Month 4)

Secondary Outcomes (3)

• Improvements in muscle oxidative capacity, as measured by near infrared spectroscopy (NIRS)

• Improvements in local muscle blood flow by NIRS and plethysmography

• Improvement in arterial endothelial function (all measured at Month 4)

Interventions

Resistance and Aerobic Training BEHAVIORAL

Eligibility Criteria

• Age: 65 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Class II and III CHF that has been clinically stable for at least 6 months
• Systolic ejection fraction (LVEF) between 20% and 40%
• Under the care of a cardiologist who is willing to have the patient participate in the study and who will continue to follow the patient medically during his/her participation
• Willing and able to undergo the screening procedures and the 1 month observation period to determine eligibility
• Willing and able to come to the research center three times a week for 4 months to participate in an exercise program consisting of either aerobic exercise only, or aerobic exercise plus resistance training
• Able to speak and read English
• Willing to participate in the study after having the study explained to him/her and has signed an informed consent form

You may not qualify if:

• Eligible for a cardiac rehabilitation program under Medicare rules due to a recent acute event
• Any medical condition that would make either exercise unsafe or uncomfortable, such as symptomatic COPD, severe arthritis, severe peripheral vascular disease, unstable heart disease, uncontrolled blood pressure, or neurological conditions
• Other complicating diseases, such as severe anemia or other blood dyscrasia affecting function, chronic renal failure, progressive cancer, or unstable diabetes

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (1)

Staten Island University Hospital

Staten Island, New York, United States

Location

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Heart Diseases

Study Officials

• Joel Posner, MD

  Chairman of Medicine, Staten Island University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Intervention Model: PARALLEL
• Sponsor Type: NIH

Study Record Dates

• First Submitted: October 15, 2004
• First Posted: October 15, 2004
• Study Start: July 1, 2006
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 29, 2016

Record last verified: 2009-02

Locations

US (1)