Status:
UNKNOWN
Mindful Movement Intervention for Post-MI Patients
Lead Sponsor:
San Diego Veterans Healthcare System
Conditions:
Myocardial Infarction
Eligibility:
All Genders
35+ years
Phase:
NA
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 rehabilitatio...
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...
Eligibility Criteria
Inclusion
- 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;
- "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.
Exclusion
- 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;
- 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.
Key Trial Info
Start Date :
October 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2016
Estimated Enrollment :
75 Patients enrolled
Trial Details
Trial ID
NCT02297737
Start Date
October 1 2013
End Date
December 1 2016
Last Update
May 6 2016
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