Myocardial InfarctionHeartChiNCT02297737
Mindful Movement Intervention for Post-MI Patients
A study testing Tai Chi and Health Education in people with Myocardial Infarction, run by San Diego Veterans Healthcare System.
Trial summary
This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for patients who have recently had a heart attack and are not participating in a standard cardiac rehabilitation program. Read more about this study
- Who is it for?
- Ages 35 years and older
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- Tai Chi and Health Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- No sites listed yet
- Study dates
- Oct 2013to Dec 2016
- 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 35 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suffered an MI (ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) with creatine kinase MB fraction elevation 3 times the upper limits of normal and with ischemic ECG changes within 6 months of baseline testing;
- Clinically stable---defined as no active arrhythmia, no residual ischemia;
- Able to perform light to moderate exercise;
- Able to give informed consent, understand study procedures and to comply with them for the entire length of the study;
- A 30 day period since Percutaneous Coronary Intervention (PCI);
- Medical clearance by their cardiologist;
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- "Treatment as usual" medications prescribed by their cardiologist (see allowed medications under 6.2. Description of Evaluations);
- Antidepressant treatment with SSRIs or SNRIs is allowed, but not required;
- > 35 years of age.
Who cannot join
- Unstable angina;
- Severe valvular disease;
- Severe COPD;
- Recent stroke or significant cerebral neurologic impairment;
- Moderate to severe suicidal risk (BDI-II #9 > 1 or from the SCID interview for MDD);
- Cancer;
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- Currently in an exercise program;
- Current uses of mood stabilizers, or antipsychotics;
- Medications (steroids) and conditions affecting immune status
- Pregnant, lactating or intending to become pregnant;
- Meets criteria for bipolar disorder, schizophrenia, substance use disorder
- Currently taking benzodiazepines and mood stabilizers
- Inability to give written informed consent in English.
- Participation in another intervention study.
About this study
Official title: Developing a Mindfulness Movement Intervention Program for Post-MI Patients: A Randomized 75-subject Pilot Clinical Trial of Tai Chi Versus Health Education in Post-myocardial Infarction Patients
This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for patients who have recently had a heart attack and are not participating in a standard cardiac rehabilitation program. Half of the 75 patients will be randomly assigned to the Tai Chi condition and the other half will be assigned to 12 weeks of Health Education. In addition to examining feasibility and acceptability, the investigators will evaluate the impact of participation in the Tai Chi condition on measures of cardiac health, physical function, self-reported health behaviors, and mental health as compared to Health Education within the context of this developmental/exploratory study.
Read the detailed description
Each year around 785,000 Americans endure a first heart attack and more than half will have another in the future. The American Heart Association (AHA) recommends exercise-based cardiac rehabilitation (CR) to aid prevention of future heart attacks. Despite the benefits of CR, only a small proportion of eligible patients participate in CR. Patients with other illnesses, women, older adults, and ethnic minorities are least likely to utilize CR services. Many medical centers do not have CR programs and patients have to travel to distant locations to undergo CR. In turn, Tai Chi has been studied in the elderly, requires no expensive equipment, can be practiced at home, and is well tolerated across fitness levels and co-occurring illnesses. Tai Chi serves as an aerobic exercise of low to moderate intensity. However, no Tai Chi studies in post-MI patients have employed state-of-the-art measures of cardiac function and exercise capacity and therefore it is unclear whether Tai Chi has similar benefits as CR during the period of recovery from a heart attack. This study is innovative in that it specifically targets patients who have not opted to participate in a formal CR program within 6 months of a first-time heart attack and emphasizes recruitment of patients spanning an older age range, physical function ability, women and minorities. A total of 75 men and women with a first time heart attack will be randomly assigned to 24 sessions of Tai Chi training composed of 8 meditative movements or to an equivalent "dose" of Health Education classes. Clinical assessments will be performed over a 4-5 month period, with testing occurring before, mid-way, after treatment, and at an 8-week follow-up. Our goal is to gather preliminary data on study feasibility, acceptability and to find indications of improvements in measures of cardiac health, physical function, health behaviors, and mental health. If the aims are met from this exploratory/development study, a future large scale study will be undertaken to confirm Tai Chi's effectiveness in post-heart attack patients. Such research is critically needed to aid the development of effective rehabilitative interventions that will be acceptable to a wider range of patients.
- Conditions
- Myocardial Infarction
- Being tested
- Tai Chi, Health Education
- Keywords
- Tai Chi
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tai ChiBehavioural
Health EducationOther
| Study group | Role | What they receive |
|---|---|---|
| Tai Chi | Experimental | A manual consisting of 8 movements learned over a period of 12 weeks will be used to teach participants in the Tai Chi condition. Classes will include around 5-6 subjects, each class lasting one hour, including a 10-minute warm-up and cool-down, and meet twice per week. Patients will be told to practice Tai Chi three times/week at home. After 12 weeks of training patients will be told to practice at home five times/week for 8 more weeks, until the 8-week follow-up visit. Subjects will be asked to rate their perceived exertion/work intensity during each session using the Borg's perceived exertion scale and asked to increase the size of their movements to reach 12-13 (moderate difficulty), which consistently matches with 65-70% of HR max. Receives: Behavioral: Tai Chi |
| Health Education | Active comparator | Participants in the Health Education condition will also meet for one hour, twice per week for 12 weeks for a total of 24 hours. Sessions will be highly structured and will emphasize key concepts in the presentations. Medical and allied health experts will provide twelve didactic videotaped presentations on a series of health-related themes and a group leader will be present to answer questions. Themes will include: Epidemiology of Cardiovascular Disease, Patient/Physician Communication, Medication Adherence, Nutrition and Exercise, The Nature and Structure of Sleep, and Navigating the Health Care System. Receives: Other: Health Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)
Recruitment rates will be recorded.
Measured: Two years
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Barriers to CR)
Barriers to CR will be queried at baseline and at the end of the interventions to determine changes in attitudes.
Measured: Two years
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (6-item credibility/expectancy questionnaire (CEQ)
A 6-item credibility/expectancy questionnaire (CEQ) will be measured at baseline and monthly to determine Tai Chi and Health Education acceptability.
Measured: Two years
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (retention rates, exit interviews)
Retention rates will be recorded, and exit interviews administered to determine reasons for drop-out. Adherence to exercise in general, and Tai Chi specifically, will be derived from exercise logs. The Exercise Benefits/Barriers Scale (EBBS) will be administered at baseline and each time point and an exit interview on the post-intervention visit will query barriers to attending Tai Chi classes and practice, as well as attendance of Health Education classes.
Measured: Two years
Secondary outcomes (14)
Physical function (Six-minute walk test)
Six-minute walk test
Measured: Five months
Psychological and health behaviors (Beck Depression Inventory)
Beck Depression Inventory
Measured: Five months
Biomarkers of cardiac risk (CRP, BNP, sST2)
Inflammatory Biomarkers (CRP, BNP, sST2)
Measured: Five months
Cardiac Function (Blood pressure and heart rate)
Blood pressure and heart rate
Measured: Five months
Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)
Cardiac Self-Efficacy Questionnaire
Measured: Five Months
Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)
Five Facets of Mindfulness Questionnaire
Measured: Five Months
Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)
Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale
Measured: Five Months
Psychological and health behaviors (Goldberg Anxiety and Depression Scale)
Goldberg Anxiety and Depression Scale
Measured: Five Months
Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)
Morisky 8-item Medication Adherence Scale
Measured: Five Months
Psychological and health behaviors (Perceived Stress Scale)
Perceived Stress Scale
Measured: Five Months
Psychological and health behaviors (Pittsburgh Sleep Quality Index)
Pittsburgh Sleep Quality Index
Measured: Five Months
Psychological and health behaviors (Positive and Negative Affect Schedule)
Positive and Negative Affect Schedule
Measured: Five Months
Psychological and health behaviors (Short Form--12 Health Survey)
Short Form--12 Health Survey
Measured: Five Months
Psychological and health behaviors (SCID-I N/P Mood Module)
SCID-I N/P Mood Module,
Measured: Five Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2014 (estimated)
- Study startOct 2013
- Primary completionJun 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- 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
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- San Diego Veterans Healthcare System
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Laura S. Redwine, PhD, San Diego Veterans Healthcare System
- Investigators
- Laura S Redwine, PhD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02297737
- Sponsor's protocol ID
- 1R21AT007600-01A1
- Acronym
- HeartChi
- Status last verified
- May 2016
- First submitted
- 19 Sep 2014
- Last updated
- 6 May 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Developing a Mindfulness Movement Intervention Program for Post-MI Patients: A Randomized 75-subject Pilot Clinical Trial of Tai Chi Versus Health Education in Post-myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT02297737
- Acronym / sponsor ID
- HeartChi / 1R21AT007600-01A1
- Conditions
- Myocardial Infarction
- Keywords
- Tai Chi
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- San Diego Veterans Healthcare SystemUS federal agency
- Study start
- Oct 2013
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 21 Nov 2014 (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.
This study evaluates the feasibility and acceptability of a 12-week Tai Chi intervention for patients who have recently had a heart attack and are not participating in a standard cardiac rehabilitation program. Half of the 75 patients will be randomly assigned to the Tai Chi condition and the other half will be assigned to 12 weeks of Health Education. In addition to examining feasibility and acceptability, the investigators will evaluate the impact of participation in the Tai Chi condition on measures of cardiac health, physical function, self-reported health behaviors, and mental health as compared to Health Education within the context of this developmental/exploratory study.
Detailed description
Each year around 785,000 Americans endure a first heart attack and more than half will have another in the future. The American Heart Association (AHA) recommends exercise-based cardiac rehabilitation (CR) to aid prevention of future heart attacks. Despite the benefits of CR, only a small proportion of eligible patients participate in CR. Patients with other illnesses, women, older adults, and ethnic minorities are least likely to utilize CR services. Many medical centers do not have CR programs and patients have to travel to distant locations to undergo CR. In turn, Tai Chi has been studied in the elderly, requires no expensive equipment, can be practiced at home, and is well tolerated across fitness levels and co-occurring illnesses. Tai Chi serves as an aerobic exercise of low to moderate intensity. However, no Tai Chi studies in post-MI patients have employed state-of-the-art measures of cardiac function and exercise capacity and therefore it is unclear whether Tai Chi has similar benefits as CR during the period of recovery from a heart attack. This study is innovative in that it specifically targets patients who have not opted to participate in a formal CR program within 6 months of a first-time heart attack and emphasizes recruitment of patients spanning an older age range, physical function ability, women and minorities. A total of 75 men and women with a first time heart attack will be randomly assigned to 24 sessions of Tai Chi training composed of 8 meditative movements or to an equivalent "dose" of Health Education classes. Clinical assessments will be performed over a 4-5 month period, with testing occurring before, mid-way, after treatment, and at an 8-week follow-up. Our goal is to gather preliminary data on study feasibility, acceptability and to find indications of improvements in measures of cardiac health, physical function, health behaviors, and mental health. If the aims are met from this exploratory/development study, a future large scale study will be undertaken to confirm Tai Chi's effectiveness in post-heart attack patients. Such research is critically needed to aid the development of effective rehabilitative interventions that will be acceptable to a wider range of patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tai Chi | Experimental | Behavioral: Tai ChiA manual consisting of 8 movements learned over a period of 12 weeks will be used to teach participants in the Tai Chi condition. Classes will include around 5-6 subjects, each class lasting one hour, including a 10-minute warm-up and cool-down, and meet twice per week. Patients will be told to practice Tai Chi three times/week at home. After 12 weeks of training patients will be told to practice at home five times/week for 8 more weeks, until the 8-week follow-up visit. Subjects will be asked to rate their perceived exertion/work intensity during each session using the Borg's perceived exertion scale and asked to increase the size of their movements to reach 12-13 (moderate difficulty), which consistently matches with 65-70% of HR max. |
| Health Education | Active comparator | Other: Health EducationParticipants in the Health Education condition will also meet for one hour, twice per week for 12 weeks for a total of 24 hours. Sessions will be highly structured and will emphasize key concepts in the presentations. Medical and allied health experts will provide twelve didactic videotaped presentations on a series of health-related themes and a group leader will be present to answer questions. Themes will include: Epidemiology of Cardiovascular Disease, Patient/Physician Communication, Medication Adherence, Nutrition and Exercise, The Nature and Structure of Sleep, and Navigating the Health Care System. |
Who may qualify
- Ages
- 35 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Suffered an MI (ST Elevation MI (STEMI) or Non-ST Elevation MI (NSTEMI) with creatine kinase MB fraction elevation 3 times the upper limits of normal and with ischemic ECG changes within 6 months of baseline testing;
- Clinically stable---defined as no active arrhythmia, no residual ischemia;
- Able to perform light to moderate exercise;
- Able to give informed consent, understand study procedures and to comply with them for the entire length of the study;
- A 30 day period since Percutaneous Coronary Intervention (PCI);
Key exclusion criteria (14 listed)
- Unstable angina;
- Severe valvular disease;
- Severe COPD;
- Recent stroke or significant cerebral neurologic impairment;
- Moderate to severe suicidal risk (BDI-II #9 > 1 or from the SCID interview for MDD);
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 Chi | Behavioural | Tai Chi |
| Health Education | Other | Health Education |
Primary outcome
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)
Time frame: Two years
Recruitment rates will be recorded.
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Barriers to CR)
Time frame: Two years
Barriers to CR will be queried at baseline and at the end of the interventions to determine changes in attitudes.
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (6-item credibility/expectancy questionnaire (CEQ)
Time frame: Two years
A 6-item credibility/expectancy questionnaire (CEQ) will be measured at baseline and monthly to determine Tai Chi and Health Education acceptability.
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (retention rates, exit interviews)
Time frame: Two years
Retention rates will be recorded, and exit interviews administered to determine reasons for drop-out. Adherence to exercise in general, and Tai Chi specifically, will be derived from exercise logs. The Exercise Benefits/Barriers Scale (EBBS) will be administered at baseline and each time point and an exit interview on the post-intervention visit will query barriers to attending Tai Chi classes and practice, as well as attendance of Health Education classes.
14 secondary outcomes
Physical function (Six-minute walk test)
Time frame: Five months
Psychological and health behaviors (Beck Depression Inventory)
Time frame: Five months
Biomarkers of cardiac risk (CRP, BNP, sST2)
Time frame: Five months
Cardiac Function (Blood pressure and heart rate)
Time frame: Five months
Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)
Time frame: Five Months
Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)
Time frame: Five Months
Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)
Time frame: Five Months
Psychological and health behaviors (Goldberg Anxiety and Depression Scale)
Time frame: Five Months
Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)
Time frame: Five Months
Psychological and health behaviors (Perceived Stress Scale)
Time frame: Five Months
Psychological and health behaviors (Pittsburgh Sleep Quality Index)
Time frame: Five Months
Psychological and health behaviors (Positive and Negative Affect Schedule)
Time frame: Five Months
Psychological and health behaviors (Short Form--12 Health Survey)
Time frame: Five Months
Psychological and health behaviors (SCID-I N/P Mood Module)
Time frame: Five Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2016.
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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
Questions about this trial
What is this clinical trial studying?
A study testing Tai Chi and Health Education in people with Myocardial Infarction, run by San Diego Veterans Healthcare System.
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 9 inclusion and 14 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: status not confirmed, as of the sponsor's last update on 6 May 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
Results are not available in the source record.
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?
Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates) (time frame: Two years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 May 2016.