Exploring Behavioral Interventions to Improve Heart Failure

University of California San Diego

Status: Completed

Conditions: Heart Failure

Treatments: Behavioral: Health Education; Behavioral: Tai Chi; Behavioral: Resistance Band

Study type: Interventional

Funder types: Other; Other U.S. Federal agency

Identifiers

NCT01625819

1R01HL096784-01A2

Details and patient eligibility

About

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.

Enrollment: 135 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. 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.
2. Symptoms of chronic heart failure for at least 3 months.
3. 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.
4. ACC/AHA stages B and C
5. Ability to perform light to moderate exercise (NYHA functional class II and III)
6. Presence of HF with an ejection fraction less than 40%, or diastolic dysfunction
7. Ability to give informed consent
8. At least18 years of age

Exclusion criteria

1. History of recent myocardial infarction (1 month)
2. Angina not adequately managed with nitrates.
3. Aortic or mitral stenosis
4. Coronary revascularization, mitral valve repair or any other cardiac surgery or implantation of a biventricular pacemaker within the past 6 months.
5. Severe COPD
6. Recent stroke or significant cerebral neurologic impairment.
7. Active Suicidality
8. Currently participating in an exercise program.
9. Currently taking mood stabilizers (e.g. lithium), benzodiazepines or antipsychotics.
10. 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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135 participants in 4 patient groups, including a placebo group

Tai Chi

Experimental group

Description:

32 1-hour group sessions of Tai Chi instruction

Treatment:

Behavioral: Tai Chi

Resistance Band

Active Comparator group

Description:

32 1-hour bi-weekly group sessions of Resistance Band exercises

Treatment:

Behavioral: Resistance Band

Health Education

Placebo Comparator group

Description:

32 1-hour bi-weekly group sessions of health education

Treatment:

Behavioral: Health Education

Care as Usual

No Intervention group

Description:

Receive usual cardiology care for 4 months between pre- and post-treatment testing