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Mindful Movement Intervention for Post-MI Patients (HeartChi)

Primary Purpose

Myocardial Infarction

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Tai Chi
Health Education
Sponsored by
San Diego Veterans Healthcare System
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Myocardial Infarction focused on measuring Tai Chi

Eligibility Criteria

35 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    Tai Chi

    Health Education

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)
    Recruitment rates will be recorded.
    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.
    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.
    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.

    Secondary Outcome Measures

    Physical function (Six-minute walk test)
    Six-minute walk test
    Psychological and health behaviors (Beck Depression Inventory)
    Beck Depression Inventory
    Biomarkers of cardiac risk (CRP, BNP, sST2)
    Inflammatory Biomarkers (CRP, BNP, sST2)
    Cardiac Function (Blood pressure and heart rate)
    Blood pressure and heart rate
    Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)
    Cardiac Self-Efficacy Questionnaire
    Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)
    Five Facets of Mindfulness Questionnaire
    Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)
    Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale
    Psychological and health behaviors (Goldberg Anxiety and Depression Scale)
    Goldberg Anxiety and Depression Scale
    Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)
    Morisky 8-item Medication Adherence Scale
    Psychological and health behaviors (Perceived Stress Scale)
    Perceived Stress Scale
    Psychological and health behaviors (Pittsburgh Sleep Quality Index)
    Pittsburgh Sleep Quality Index
    Psychological and health behaviors (Positive and Negative Affect Schedule)
    Positive and Negative Affect Schedule
    Psychological and health behaviors (Short Form--12 Health Survey)
    Short Form--12 Health Survey
    Psychological and health behaviors (SCID-I N/P Mood Module)
    SCID-I N/P Mood Module,

    Full Information

    First Posted
    September 19, 2014
    Last Updated
    May 5, 2016
    Sponsor
    San Diego Veterans Healthcare System
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02297737
    Brief Title
    Mindful Movement Intervention for Post-MI Patients
    Acronym
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2013 (undefined)
    Primary Completion Date
    June 2016 (Anticipated)
    Study Completion Date
    December 2016 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    San Diego Veterans Healthcare System

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Myocardial Infarction
    Keywords
    Tai Chi

    7. Study Design

    Primary Purpose
    Supportive Care
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    75 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tai Chi
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Health Education
    Arm Type
    Active Comparator
    Arm Description
    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.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tai Chi
    Intervention Type
    Other
    Intervention Name(s)
    Health Education
    Primary Outcome Measure Information:
    Title
    Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Recruitment rates)
    Description
    Recruitment rates will be recorded.
    Time Frame
    Two years
    Title
    Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (Barriers to CR)
    Description
    Barriers to CR will be queried at baseline and at the end of the interventions to determine changes in attitudes.
    Time Frame
    Two years
    Title
    Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (6-item credibility/expectancy questionnaire (CEQ)
    Description
    A 6-item credibility/expectancy questionnaire (CEQ) will be measured at baseline and monthly to determine Tai Chi and Health Education acceptability.
    Time Frame
    Two years
    Title
    Feasibility, Treatment Expectancy/Satisfaction, Retention, and Adherence (retention rates, exit interviews)
    Description
    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.
    Time Frame
    Two years
    Secondary Outcome Measure Information:
    Title
    Physical function (Six-minute walk test)
    Description
    Six-minute walk test
    Time Frame
    Five months
    Title
    Psychological and health behaviors (Beck Depression Inventory)
    Description
    Beck Depression Inventory
    Time Frame
    Five months
    Title
    Biomarkers of cardiac risk (CRP, BNP, sST2)
    Description
    Inflammatory Biomarkers (CRP, BNP, sST2)
    Time Frame
    Five months
    Title
    Cardiac Function (Blood pressure and heart rate)
    Description
    Blood pressure and heart rate
    Time Frame
    Five months
    Title
    Psychological and health behaviors (Cardiac Self-Efficacy Questionnaire)
    Description
    Cardiac Self-Efficacy Questionnaire
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Five Facets of Mindfulness Questionnaire)
    Description
    Five Facets of Mindfulness Questionnaire
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale)
    Description
    Functional Assessment of Chronic Illness Therapy--Spiritual Well-Being Scale
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Goldberg Anxiety and Depression Scale)
    Description
    Goldberg Anxiety and Depression Scale
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Morisky 8-item Medication Adherence Scale)
    Description
    Morisky 8-item Medication Adherence Scale
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Perceived Stress Scale)
    Description
    Perceived Stress Scale
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Pittsburgh Sleep Quality Index)
    Description
    Pittsburgh Sleep Quality Index
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Positive and Negative Affect Schedule)
    Description
    Positive and Negative Affect Schedule
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (Short Form--12 Health Survey)
    Description
    Short Form--12 Health Survey
    Time Frame
    Five Months
    Title
    Psychological and health behaviors (SCID-I N/P Mood Module)
    Description
    SCID-I N/P Mood Module,
    Time Frame
    Five Months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    35 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Criteria: 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Laura S Redwine, PhD
    Organizational Affiliation
    University of California, San Diego
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    Mindful Movement Intervention for Post-MI Patients

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