Heart Failure Clinical Trial

Exploring Behavioral Interventions to Improve Heart Failure

Summary

The objective of this research is to compare Tai Chi versus Resistance Exercise, Health Education and usual care for changes in cardiac functional capacity measured for ability of the heart to pump by measuring ejection fraction (EF), end systolic and diastolic volumes in heart failure (HF) patients. Also measured will be changes in physical function measured by walking speed and distance in the 6-min walk task, work performed during a bicycle task, and changes in daily physical activity. The investigators will compare groups for altered well-being including: depression, sleep disturbances, fatigue, mindfulness, spirituality and quality of life. In addition the investigators will compare groups for altered vascular and pro-inflammatory markers, catecholamines, and autonomic function at rest and in response to the bicycle task. Also, the investigators will assess cardiac related hospitalization and death over a 12 month period by examining medical records.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Ability to perform a 6-minute walk task, with or without use of a cane or walker (must use the same walking assistance device during each session), and walk under 500 meters during task.
Symptoms of chronic heart failure for at least 3 months.
Clinically stable- defined as not having been hospitalized for a 3 month period, on stable doses of neurohormonal blocking agents and diuretics for at least 3 months.
ACC/AHA stages B and C
Ability to perform light to moderate exercise (NYHA functional class II and III)
Presence of HF with an ejection fraction less than 40%, or diastolic dysfunction
Ability to give informed consent
At least18 years of age

Exclusion Criteria:

History of recent myocardial infarction (1 month)
Angina not adequately managed with nitrates.
Aortic or mitral stenosis
Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
Severe COPD
Recent stroke or significant cerebral neurologic impairment.
Active Suicidality
Currently participating in an exercise program.
Currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
Medications (steroids) and medical conditions affecting immune status not limited to Grave's Disease, Rheumatoid Arthritis, Hashimoto's Disease, Sjogren's Disease, Lupus, Multiple Sclerosis

Study is for people with:

Heart Failure

Estimated Enrollment:

135

Study ID:

NCT01625819

Recruitment Status:

Completed

Sponsor:

University of California, San Diego

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There is 1 Location for this study

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University of Califoria, San Diego
La Jolla California, 92093, United States

How clear is this clinincal trial information?

Study is for people with:

Heart Failure

Estimated Enrollment:

135

Study ID:

NCT01625819

Recruitment Status:

Completed

Sponsor:


University of California, San Diego

How clear is this clinincal trial information?

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