Clinical trial NCT01625819: Exploring Behavioral Interventions to Improve Heart Failure
Official title: Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heart Failure
Keywords: Tai Chi
Lead sponsor: University of California, San Diego
Sponsor class: OTHER
Collaborators: name: San Diego Veterans Healthcare System
First posted: 2012-06-21
Enrollment: 135
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Left Ventricular Ejection Fraction (%LVEF)
timeFrame: Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
measure: End Systolic Volume (ESV)
timeFrame: Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
measure: End Diastolic Volume (EDV)
timeFrame: Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
Secondary outcomes:
measure: B-type Natriuretic Peptide (BNP)
timeFrame: Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
measure: Six-Minute Walk Task (6MWT)
timeFrame: Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
measure: Work Performed on Bicycle Ergometer Task (Watts)
timeFrame: Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
measure: Average Number of Steps Across 3 Days (Steps)
timeFrame: Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
measure: Beck Depression Inventory (BDI) at Post-Treatment
timeFrame: Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
measure: BDI at 8-Week Follow-Up
timeFrame: Change from Baseline in BDI scores at 8-week follow-up
measure: BDI at 1-Year Follow-Up
timeFrame: Change from Baseline in BDI Scores at 1-year follow-up
measure: Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment
timeFrame: Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
measure: PSQI at 8-Week Follow-Up
timeFrame: Change from Baseline in PSQI scores at 8-week follow-up
measure: PSQI at 1-Year Follow-Up
timeFrame: Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
measure: Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment
timeFrame: Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
measure: MFSI at 8-Week Follow-Up
timeFrame: Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
measure: MFSI at 1-Year Follow-Up
timeFrame: Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
measure: Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment
timeFrame: Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
measure: MHLFQ at 8-Week Follow-Up
timeFrame: Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
measure: MHLFQ at 1-Year Follow-Up Assessment
timeFrame: Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: University of Califoria, San Diego
state: California
Study officials:
affiliation: University of California, San Diego
name: Laura S Redwine, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.