Mindful Movement Intervention for Post-MI Patients

NCT02297737 | Unknown DMC

• 1 other identifier: 1R21AT007600-01A1
• Study Type: interventional
• Target: 75
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Myocardial Infarction

Keywords

Tai Chi

Outcome Measures

Primary Outcomes (4)

• Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)

  Recruitment rates will be recorded.

  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.

  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.

  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.

  Two years

Secondary Outcomes (14)

• Physical function (Six-minute walk test)

  Five months

• Psychological and health behaviors (Beck Depression Inventory)

  Five months

• Biomarkers of cardiac risk (CRP, BNP, sST2)

  Five months

• Cardiac Function (Blood pressure and heart rate)

  Five months

• Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)

  Five Months

Study Arms (2)

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.

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.

Other: Health Education

Interventions

Tai Chi BEHAVIORAL

Tai Chi

Health Education OTHER

Health Education

Eligibility Criteria

• Age: 35 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• San Diego Veterans Healthcare System: lead

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Tai Ji

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Laura S Redwine, PhD

  University of California, San Diego

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asst Adjunct Prof

Study Record Dates

• First Submitted: September 19, 2014
• First Posted: November 21, 2014
• Study Start: October 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 6, 2016

Record last verified: 2016-05