Clinical trial NCT02297737: Mindful Movement Intervention for Post-MI Patients
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Myocardial Infarction
Keywords: Tai Chi
Lead sponsor: San Diego Veterans Healthcare System
Sponsor class: FED
First posted: 2014-11-21
Enrollment: 75
Sex: ALL
Minimum age (years): 35
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

1. 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;
2. Clinically stable---defined as no active arrhythmia, no residual ischemia;
3. Able to perform light to moderate exercise;
4. Able to give informed consent, understand study procedures and to comply with them for the entire length of the study;
5. A 30 day period since Percutaneous Coronary Intervention (PCI);
6. Medical clearance by their cardiologist;
7. "Treatment as usual" medications prescribed by their cardiologist (see allowed medications under 6.2. Description of Evaluations);
8. Antidepressant treatment with SSRIs or SNRIs is allowed, but not required;
9. \> 35 years of age.

Exclusion Criteria:

1. Unstable angina;
2. Severe valvular disease;
3. Severe COPD;
4. Recent stroke or significant cerebral neurologic impairment;
5. Moderate to severe suicidal risk (BDI-II #9 \> 1 or from the SCID interview for MDD);
6. Cancer;
7. Currently in an exercise program;
8. Current uses of mood stabilizers, or antipsychotics;
9. Medications (steroids) and conditions affecting immune status
10. Pregnant, lactating or intending to become pregnant;
11. Meets criteria for bipolar disorder, schizophrenia, substance use disorder
12. Currently taking benzodiazepines and mood stabilizers
13. Inability to give written informed consent in English.
14. Participation in another intervention study.

Primary outcomes:
measure: Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)
timeFrame: Two years
measure: Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Barriers to CR)
timeFrame: Two years
measure: Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (6-item credibility/expectancy questionnaire (CEQ)
timeFrame: Two years
measure: Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (retention rates, exit interviews)
timeFrame: Two years
Secondary outcomes:
measure: Physical function (Six-minute walk test)
timeFrame: Five months
measure: Psychological and health behaviors (Beck Depression Inventory)
timeFrame: Five months
measure: Biomarkers of cardiac risk (CRP, BNP, sST2)
timeFrame: Five months
measure: Cardiac Function (Blood pressure and heart rate)
timeFrame: Five months
measure: Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)
timeFrame: Five Months
measure: Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)
timeFrame: Five Months
measure: Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)
timeFrame: Five Months
measure: Psychological and health behaviors (Goldberg Anxiety and Depression Scale)
timeFrame: Five Months
measure: Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)
timeFrame: Five Months
measure: Psychological and health behaviors (Perceived Stress Scale)
timeFrame: Five Months
measure: Psychological and health behaviors (Pittsburgh Sleep Quality Index)
timeFrame: Five Months
measure: Psychological and health behaviors (Positive and Negative Affect Schedule)
timeFrame: Five Months
measure: Psychological and health behaviors (Short Form--12 Health Survey)
timeFrame: Five Months
measure: Psychological and health behaviors (SCID-I N/P Mood Module)
timeFrame: Five Months
Other outcomes:
Locations:
Study officials:
affiliation: University of California, San Diego
name: Laura S Redwine, PhD
role: PRINCIPAL_INVESTIGATOR
References: