Back to resultsExploring Behavioral Interventions to Improve Heart Failure
Primary Purpose
Heart Failure
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tai Chi
Resistance Band
Health Education
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure focused on measuring Tai Chi
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- University of Califoria, San Diego
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Active Comparator
Placebo Comparator
No Intervention
Arm Label
Tai Chi
Resistance Band
Health Education
Care as Usual
Arm Description
32 1-hour group sessions of Tai Chi instruction
32 1-hour bi-weekly group sessions of Resistance Band exercises
32 1-hour bi-weekly group sessions of health education
Receive usual cardiology care for 4 months between pre- and post-treatment testing
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT01625819
First Posted
April 18, 2012
Last Updated
January 7, 2016
Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System
1. Study Identification
Unique Protocol Identification Number
NCT01625819
Brief Title
Exploring Behavioral Interventions to Improve Heart Failure
Official Title
Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
August 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of California, San Diego
Collaborators
San Diego Veterans Healthcare System
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure
Keywords
Tai Chi
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Tai Chi
Arm Type
Experimental
Arm Description
32 1-hour group sessions of Tai Chi instruction
Arm Title
Resistance Band
Arm Type
Active Comparator
Arm Description
32 1-hour bi-weekly group sessions of Resistance Band exercises
Arm Title
Health Education
Arm Type
Placebo Comparator
Arm Description
32 1-hour bi-weekly group sessions of health education
Arm Title
Care as Usual
Arm Type
No Intervention
Arm Description
Receive usual cardiology care for 4 months between pre- and post-treatment testing
Intervention Type
Behavioral
Intervention Name(s)
Tai Chi
Intervention Description
32 1-hour bi-weekly group sessions of Tai Chi instruction
Intervention Type
Behavioral
Intervention Name(s)
Resistance Band
Intervention Description
32 1-hour bi-weekly group sessions of Resistance Band exercises
Intervention Type
Behavioral
Intervention Name(s)
Health Education
Intervention Description
32 1-hour bi-weekly group sessions of health education
Primary Outcome Measure Information:
Title
Left Ventricular Ejection Fraction (%LVEF)
Description
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.
Time Frame
Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
Title
End Systolic Volume (ESV)
Description
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.
Time Frame
Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
Title
End Diastolic Volume (EDV)
Description
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.
Time Frame
Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
Secondary Outcome Measure Information:
Title
B-type Natriuretic Peptide (BNP)
Description
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.
Time Frame
Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Title
Six-Minute Walk Task (6MWT)
Description
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.
Time Frame
Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Title
Work Performed on Bicycle Ergometer Task (Watts)
Description
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.
Time Frame
Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Title
Average Number of Steps Across 3 Days (Steps)
Description
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.
Time Frame
Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Title
Beck Depression Inventory (BDI) at Post-Treatment
Description
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.
Time Frame
Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
Title
BDI at 8-Week Follow-Up
Description
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.
Time Frame
Change from Baseline in BDI scores at 8-week follow-up
Title
BDI at 1-Year Follow-Up
Description
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.
Time Frame
Change from Baseline in BDI Scores at 1-year follow-up
Title
Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment
Description
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.
Time Frame
Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
Title
PSQI at 8-Week Follow-Up
Description
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.
Time Frame
Change from Baseline in PSQI scores at 8-week follow-up
Title
PSQI at 1-Year Follow-Up
Description
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.
Time Frame
Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
Title
Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment
Description
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.
Time Frame
Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
Title
MFSI at 8-Week Follow-Up
Description
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.
Time Frame
Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
Title
MFSI at 1-Year Follow-Up
Description
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.
Time Frame
Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
Title
Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment
Description
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.
Time Frame
Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
Title
MHLFQ at 8-Week Follow-Up
Description
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.
Time Frame
Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
Title
MHLFQ at 1-Year Follow-Up Assessment
Description
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.
Time Frame
Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laura S Redwine, PhD
Organizational Affiliation
University of California, San Diego
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Califoria, San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
31786338
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.
Results Reference
derived
Learn more about this trial
Exploring Behavioral Interventions to Improve Heart Failure
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