Mindful Movement Intervention for Post-MI Patients

Myocardial Infarction Clinical Trial

— HeartChi  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT02297737
• Other study ID #: 1R21AT007600-01A1
• Status: Enrolling by invitation
• Phase: N/A
• First received: September 19, 2014
• Last updated: May 5, 2016
• Start date: October 2013
• Est. completion date: December 2016

Study information

• Verified date: May 2016
• Source: San Diego Veterans Healthcare System
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Federal GovernmentUnited States: Data and Safety Monitoring Board
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 75
• Est. completion date: December 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 35 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction

Intervention

Behavioral:
• Tai Chi

Other:
• Health Education

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
San Diego Veterans Healthcare System

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)	Recruitment rates will be recorded.	Two years	No
Primary	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.	Two years	No
Primary	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.	Two years	No
Primary	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.	Two years	No
Secondary	Physical function (Six-minute walk test)	Six-minute walk test	Five months	No
Secondary	Psychological and health behaviors (Beck Depression Inventory)	Beck Depression Inventory	Five months	No
Secondary	Biomarkers of cardiac risk (CRP, BNP, sST2)	Inflammatory Biomarkers (CRP, BNP, sST2)	Five months	No
Secondary	Cardiac Function (Blood pressure and heart rate)	Blood pressure and heart rate	Five months	No
Secondary	Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)	Cardiac Self-Efficacy Questionnaire	Five Months	No
Secondary	Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)	Five Facets of Mindfulness Questionnaire	Five Months	No
Secondary	Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)	Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale	Five Months	No
Secondary	Psychological and health behaviors (Goldberg Anxiety and Depression Scale)	Goldberg Anxiety and Depression Scale	Five Months	No
Secondary	Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)	Morisky 8-item Medication Adherence Scale	Five Months	No
Secondary	Psychological and health behaviors (Perceived Stress Scale)	Perceived Stress Scale	Five Months	No
Secondary	Psychological and health behaviors (Pittsburgh Sleep Quality Index)	Pittsburgh Sleep Quality Index	Five Months	No
Secondary	Psychological and health behaviors (Positive and Negative Affect Schedule)	Positive and Negative Affect Schedule	Five Months	No
Secondary	Psychological and health behaviors (Short Form--12 Health Survey)	Short Form--12 Health Survey	Five Months	No
Secondary	Psychological and health behaviors (SCID-I N/P Mood Module)	SCID-I N/P Mood Module,	Five Months	No