Heart FailureNCT01625819
Exploring Behavioral Interventions to Improve Heart Failure
A study testing Tai Chi, Resistance Band and Health Education in people with Heart Failure, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Tai Chi, Resistance Band and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Califoria, San Diego
La Jolla, California, 92093
About this study
Official title: 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.
- Conditions
- Heart Failure
- Being tested
- Tai Chi, Resistance Band, Health Education
- Keywords
- Tai Chi
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
32 1-hour bi-weekly group sessions of Tai Chi instruction
Resistance BandBehavioural
32 1-hour bi-weekly group sessions of Resistance Band exercises
Health EducationBehavioural
32 1-hour bi-weekly group sessions of health education
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | 32 1-hour group sessions of Tai Chi instruction Receives: Behavioral: Tai Chi |
| Resistance Band | Active comparator | 32 1-hour bi-weekly group sessions of Resistance Band exercises Receives: Behavioral: Resistance Band |
| Health Education | Placebo comparator | 32 1-hour bi-weekly group sessions of health education Receives: Behavioral: Health Education |
| Care as Usual | No intervention | Receive usual cardiology care for 4 months between pre- and post-treatment testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
Secondary outcomes (16)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2012 (estimated)
- Study startAug 2010
- Primary completionApr 2014
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Responsible party
- Principal investigator, Laura S. Redwine, PhD, University of California, San Diego
- Investigators
- Laura S Redwine, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01625819
- Sponsor's protocol ID
- 1R01HL096784-01A2
- Status last verified
- Jan 2016
- First submitted
- 18 Apr 2012
- Last updated
- 11 Jan 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 31786338
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring Tai Chi as a Behavioral Intervention for Heart Failure Patients
- ClinicalTrials.gov ID
- NCT01625819
- Acronym / sponsor ID
- 1R01HL096784-01A2
- Conditions
- Heart Failure
- Keywords
- Tai Chi
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Collaborators
- San Diego Veterans Healthcare System
- Study start
- Aug 2010
- Primary completion
- Apr 2014 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 21 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai Chi32 1-hour group sessions of Tai Chi instruction |
| Resistance Band | Active comparator | Behavioral: Resistance Band32 1-hour bi-weekly group sessions of Resistance Band exercises |
| Health Education | Placebo comparator | Behavioral: Health Education32 1-hour bi-weekly group sessions of health education |
| Care as Usual | No intervention | –Receive usual cardiology care for 4 months between pre- and post-treatment testing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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)
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tai Chi32 1-hour bi-weekly group sessions of Tai Chi instruction | Behavioural | Tai Chi |
| Resistance Band32 1-hour bi-weekly group sessions of Resistance Band exercises | Behavioural | Resistance Band |
| Health Education32 1-hour bi-weekly group sessions of health education | Behavioural | Health Education |
Primary outcome
Left Ventricular Ejection Fraction (%LVEF)
Time frame: Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment
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)
Time frame: Change from Baseline in ESV Immediately Following 16 Weeks of Treatment
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)
Time frame: Change from Baseline in EDV Immediately Following 16 Weeks of Treatment
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.
16 secondary outcomes
B-type Natriuretic Peptide (BNP)
Time frame: Change from Baseline in BNP Immediately Following 16 Weeks of Treatment
Six-Minute Walk Task (6MWT)
Time frame: Change from Baseline in 6MWT Immediately Following 16 Weeks of Treatment
Work Performed on Bicycle Ergometer Task (Watts)
Time frame: Change from Baseline in Watts Immediately Following 16 Weeks of Treatment
Average Number of Steps Across 3 Days (Steps)
Time frame: Change from Baseline in Steps Immediately Following 16 Weeks of Treatment
Beck Depression Inventory (BDI) at Post-Treatment
Time frame: Change from Baseline in BDI Scores Immediately Following 16 Weeks of Treatment
BDI at 8-Week Follow-Up
Time frame: Change from Baseline in BDI scores at 8-week follow-up
BDI at 1-Year Follow-Up
Time frame: Change from Baseline in BDI Scores at 1-year follow-up
Pittsburgh Sleep Quality Inventory (PSQI) at Post-Treatment
Time frame: Change from Baseline on the (PSQI) Immediately Following 16 Weeks of Treatment
PSQI at 8-Week Follow-Up
Time frame: Change from Baseline in PSQI scores at 8-week follow-up
PSQI at 1-Year Follow-Up
Time frame: Change from Baseline in PSQI Scores at 1-year Follow-Up Assessment
Multidimensional Fatigue Symptom Inventory (MFSI) at Post-Treatment
Time frame: Change from Baseline in MFSI Scores Immediately Following 16 Weeks of Treatment
MFSI at 8-Week Follow-Up
Time frame: Change From Baseline in MFSI Scores at 8-week Follow-up Assessment
MFSI at 1-Year Follow-Up
Time frame: Change From Baseline in MFSI Scores at the 1-Year Follow-Up Assessment
Minnesota Living with Heart Failure Questionnaire (MLHFQ) at Post-Treatment
Time frame: Change from Baseline in MLHFQ Scores Immediately Following 16 Weeks of Treatment
MHLFQ at 8-Week Follow-Up
Time frame: Change from Baseline in MHLFQ at 8-Week Follow-Up Assessment
MHLFQ at 1-Year Follow-Up Assessment
Time frame: Change from Baseline in MHLFQ Scores at 1-year Follow-Up Assessment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2016.
- Derived from this study: PubMed 31786338Redwine 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Laura S Redwine, PhD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi, Resistance Band and Health Education in people with Heart Failure, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jan 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left Ventricular Ejection Fraction (%LVEF) (time frame: Change from Baseline in %LVEF Immediately Following 16 Weeks of Treatment). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01625819, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jan 2016.