Exploring Behavioral Interventions to Improve Heart Failure

Completed · Not applicable

Conditions studied: Heart Failure

In brief

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.

Key facts

Study ID

NCT01625819

Run by

University of California, San Diego

People needed

135

Starts

2010-08-01

Expected to finish

2015-08-01

Last updated by the study team

2016-01-11

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• University of Califoria, San Diego — La Jolla, California, United States

Full record on ClinicalTrials.gov

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