Exploring Behavioral Interventions to Improve Heart Failure

Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure
• Intervention / Treatment: Behavioral: Tai Chi; Behavioral: Resistance Band; Behavioral: Health Education

• Study Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • La Jolla, California, United States, 92093
      • University of Califoria, San Diego

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Tai Chi; 32 1-hour group sessions of Tai Chi instruction	Behavioral: Tai Chi; 32 1-hour bi-weekly group sessions of Tai Chi instruction
ACTIVE_COMPARATOR: Resistance Band; 32 1-hour bi-weekly group sessions of Resistance Band exercises	Behavioral: Resistance Band; 32 1-hour bi-weekly group sessions of Resistance Band exercises
PLACEBO_COMPARATOR: Health Education; 32 1-hour bi-weekly group sessions of health education	Behavioral: Health Education; 32 1-hour bi-weekly group sessions of health education
NO_INTERVENTION: Care as Usual; Receive usual cardiology care for 4 months between pre- and post-treatment testing

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
B-type Natriuretic Peptide (BNP)	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 serum levels of BNP.	Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Six-Minute Walk Task (6MWT)	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 6MWT at post-treatment.	Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Work Performed on Bicycle Ergometer Task (Watts)	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 average watts on a mild, graded exercise task on a bicycle ergometer at post-treatment assessment.	Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Average Number of Steps Across 3 Days (Steps)	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 the average number of steps measured using a pedometer over a 3 day period immediately following 16 weeks of treatment.	Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Beck Depression Inventory (BDI) at Post-Treatment	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI immediately following 16 weeks of treatment.	Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
BDI at 8-Week Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI at the 8-week follow-up assessment.	Change from Baseline in BDI scores at 8-week follow-up
BDI at 1-Year Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in depression scores as measured by the BDI at the 1-year follow-up assessment.	Change from Baseline in BDI Scores at 1-year follow-up
Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI immediately following 16 weeks of treatment.	Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
PSQI at 8-Week Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI at the 8-week follow-up assessment.	Change from Baseline in PSQI scores at 8-week follow-up
PSQI at 1-Year Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in sleep quality scores as measured by the PSQI at the 1-year follow-up assessment.	Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI immediately following 16 weeks of treatment.	Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
MFSI at 8-Week Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI at the 8-week follow-up assessment.	Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
MFSI at 1-Year Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in fatigue scores as measured by the MFSI at the 1-year follow-up assessment.	Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores as measured by the MHLFQ immediately following 16 weeks of treatment.	Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
MHLFQ at 8-Week Follow-Up	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores scores as measured by the PSQI at the 8-week follow-up assessment.	Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
MHLFQ at 1-Year Follow-Up Assessment	Determine whether Tai Chi compared with Resistance Exercise and Health Education control condition will lead to a greater improvement in health-related quality of life scores as measured by the MHLFQ at the 1-year follow-up assessment.	Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment

Collaborators and Investigators

• Sponsor: University of California, San Diego
• Collaborators: San Diego Veterans Healthcare System
• Investigators: Principal Investigator: Laura S Redwine, PhD, University of California, San Diego

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (ACTUAL): April 1, 2014
• Study Completion (ACTUAL): August 1, 2015

Study Registration Dates

• First Submitted: April 18, 2012
• First Submitted That Met QC Criteria: June 19, 2012
• First Posted (ESTIMATE): June 21, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): January 11, 2016
• Last Update Submitted That Met QC Criteria: January 7, 2016
• Last Verified: January 1, 2016

More Information

Terms related to this study

• Keywords: Tai Chi
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Heart Failure
• Other Study ID Numbers: 1R01HL096784-01A2 (NIH)