Exploring Behavioral Interventions to Improve Heart Failure

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

135 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-08-31

Study Completion Date

2015-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Heart Failure

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tai Chi

32 1-hour group sessions of Tai Chi instruction

Group Type EXPERIMENTAL

Tai Chi

Intervention Type BEHAVIORAL

32 1-hour bi-weekly group sessions of Tai Chi instruction

Resistance Band

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

Group Type ACTIVE_COMPARATOR

Resistance Band

Intervention Type BEHAVIORAL

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

Health Education

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

Group Type PLACEBO_COMPARATOR

Health Education

Intervention Type BEHAVIORAL

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

Care as Usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Tai Chi

32 1-hour bi-weekly group sessions of Tai Chi instruction

Intervention Type BEHAVIORAL

Resistance Band

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

Intervention Type BEHAVIORAL

Health Education

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No