Exploring Behavioral Interventions to Improve Heart Failure
Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients
1 other identifier
interventional
135
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable heart-failure
Started Aug 2010
Longer than P75 for not_applicable heart-failure
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2010
CompletedFirst Submitted
Initial submission to the registry
April 18, 2012
CompletedFirst Posted
Study publicly available on registry
June 21, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2015
CompletedJanuary 11, 2016
January 1, 2016
3.7 years
April 18, 2012
January 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
Left Ventricular Ejection Fraction (%LVEF)
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by %LVEF on echocardiogram.
Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
End Systolic Volume (ESV)
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by ESV on echocardiogram.
Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
End Diastolic Volume (EDV)
Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in cardiac functional capacity as measured by EDV on echocardiogram.
Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
Secondary Outcomes (16)
B-type Natriuretic Peptide (BNP)
Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Six-Minute Walk Task (6MWT)
Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Work Performed on Bicycle Ergometer Task (Watts)
Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Average Number of Steps Across 3 Days (Steps)
Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Beck Depression Inventory (BDI) at Post-Treatment
Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
- +11 more secondary outcomes
Study Arms (4)
Tai Chi
EXPERIMENTAL32 1-hour group sessions of Tai Chi instruction
Resistance Band
ACTIVE COMPARATOR32 1-hour bi-weekly group sessions of Resistance Band exercises
Health Education
PLACEBO COMPARATOR32 1-hour bi-weekly group sessions of health education
Care as Usual
NO INTERVENTIONReceive usual cardiology care for 4 months between pre- and post-treatment testing
Interventions
32 1-hour bi-weekly group sessions of Resistance Band exercises
Eligibility Criteria
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Califoria, San Diego
La Jolla, California, 92093, United States
Related Publications (1)
Redwine LS, Pung MA, Wilson K, Bangen KJ, Delano-Wood L, Hurwitz B. An exploratory randomized sub-study of light-to-moderate intensity exercise on cognitive function, depression symptoms and inflammation in older adults with heart failure. J Psychosom Res. 2020 Jan;128:109883. doi: 10.1016/j.jpsychores.2019.109883. Epub 2019 Nov 26.
PMID: 31786338DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Laura S Redwine, PhD
University of California, San Diego
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Adjunct Professor
Study Record Dates
First Submitted
April 18, 2012
First Posted
June 21, 2012
Study Start
August 1, 2010
Primary Completion
April 1, 2014
Study Completion
August 1, 2015
Last Updated
January 11, 2016
Record last verified: 2016-01