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Online Tai Chi Plus Fitbit After ACS (Mind2Move)

Primary Purpose

Acute Coronary Syndrome, Physical Inactivity

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
Tai chi + wearable
Sponsored by
Beth Israel Deaconess Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Acute Coronary Syndrome focused on measuring tai chi, fitness tracker

Eligibility Criteria

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

Inclusion Criteria: History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria); Age ≥ 18; Being physically inactive (i.e., < 150 min/week of moderate-intensity aerobic PA); Absence of contraindications to physical exercise per the participant's provider evaluation; Access to a digital device with internet connection; Having an active email account and ability to check email at least weekly; Physician clearance to participate in low-moderate intensity exercise (tai chi), including a statement that there is no contraindication to exercise based on post-ACS stress test and other factors, as appropriate; English speaking Exclusion Criteria: Inability or unwillingness to give informed consent; Blood pressure >200/110 or orthostatic systolic blood pressure decrease >20 mmHg at the baseline visit; Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block; Within 3 months of a diagnosis of pericarditis or myocarditis; Medical conditions likely to limit lifespan to less than one year; New York Heart Association (NYHA) functional class IV; Severe cognitive impairment (BOMC >10);139 Orthopedic problems prohibiting TC practice; Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly; Current enrollment in cardiac rehabilitation; Untreated severe depression (PHQ>=20); Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis); Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Tai chi + wearable

    Enhanced usual care

    Arm Description

    48 virtual tai chi classes on Zoom over 6 months plus assigned home practice of tai chi 3x a week plus daily use of a Fitbit fitness tracker will be required for this group.

    Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.

    Outcomes

    Primary Outcome Measures

    Recruitment rate
    Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
    Retention rate
    Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit.
    Intervention enjoyment
    Intervention enjoyment will be assessed via qualitative interviews
    Intervention adherence
    Intervention adherence will be measured by collection of class attendance and home practice data.

    Secondary Outcome Measures

    Physical activity
    Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL).
    Systolic and diastolic blood pressure
    Blood pressure will be measured using a Dinamap XL automated BP monitor according to current recommendations.
    Body weight
    Body weight will be measured using an electronic scale.
    Height
    Height will be measured using a tape measure.
    Fasting glucose
    Fasting glucose will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    Lipid panel
    Lipid panel will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    hs-CRP
    hs-CRP will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    Quality of life assessed by SF-36
    Quality of life will be measured using a short version (8 items) of the Health Survey Short Form (SF-36). Scores range from 0-100, with a higher score indicating a higher quality of life.
    Intrinsic motivation
    Intrinsic Motivation Inventory is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.
    Anxiety, Depression
    Anxiety, Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity.
    Stress
    Stress will be measured using the Perceived Stress Scale (PSS) - a 10 items survey with scores ranging from 0 to 40, and higher scores indicating greater stress burden.
    Mindful awareness
    Mindful awareness will be assessed using the Five Facets of Mindfulness questionnaire (short form) a 15-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores ranges from 39-19, with a higher score being better.
    Exercise self-efficacy
    Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale. This is a 9-item validated scale from McAuley's original barriers scale. Scores range form 9-28, with a higher score meaning more self-efficacy.
    Exercise capacity
    Exercise capacity will be assessed via the 6 min walk test (6MWT), a simple, safe and reliable first-line assessment of functional status that correlates with peak oxygen uptake.

    Full Information

    First Posted
    January 6, 2023
    Last Updated
    August 11, 2023
    Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Lifespan
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05699642
    Brief Title
    Online Tai Chi Plus Fitbit After ACS
    Acronym
    Mind2Move
    Official Title
    Tai Chi Exercise and Wearable Feedback Technology to Promote Physical Activity in Acute Coronary Syndrome Survivors
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 1, 2023 (Anticipated)
    Primary Completion Date
    November 30, 2025 (Anticipated)
    Study Completion Date
    November 30, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Beth Israel Deaconess Medical Center
    Collaborators
    Lifespan

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    This projects studies the role of tai chi exercise and wearable fitness trackers to promote physical activity in acute coronary syndrome (ACS) survivors.
    Detailed Description
    This is a two-site randomized controlled trial taking place at Beth Israel Deaconess Medical Center in Boston, MA and The Miriam Hospital in Providence, RI. Seventy (n=70) physically inactive ACS survivors will be randomized to either a 6-month group tai chi program (remotely-delivered classes on Zoom) integrated with a wearable self-monitoring/feedback device plus enhanced usual care (EUC), or to EUC alone. EUC will include usual care provided by participants' providers integrated with printed CHD risk factor education materials. Assessments will be conducted in-person at baseline, 6 months (end of treatment), and 9 months. Our primary outcomes will be focused on study feasibility and acceptability. Secondary outcomes include the following patient-centered outcomes: objectively measured (via accelerometry) moderate-vigorous physical activity, light physical activity, sedentary time, cognitive-behavioral constructs (exercise self-efficacy, intrinsic motivation, depression, stress, HRQL), and cardiometabolic measures (exercise capacity, body weight, lipid profile, blood pressure, fasting plasma glucose).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Acute Coronary Syndrome, Physical Inactivity
    Keywords
    tai chi, fitness tracker

    7. Study Design

    Primary Purpose
    Other
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    70 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Tai chi + wearable
    Arm Type
    Experimental
    Arm Description
    48 virtual tai chi classes on Zoom over 6 months plus assigned home practice of tai chi 3x a week plus daily use of a Fitbit fitness tracker will be required for this group.
    Arm Title
    Enhanced usual care
    Arm Type
    No Intervention
    Arm Description
    Printed educational materials based on existing resources (e.g., AHA; Centers for Disease Control and Prevention) will be shared with subjects in this group.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Tai chi + wearable
    Intervention Description
    The tai chi intervention will be delivered remotely via Zoom Enterprise. Participants will access classes on a phone, tablet, laptop, or desktop computer. Participants will attend 3 classes/week (each lasting 60 min) during weeks 1-12, 2 classes/week during weeks 13-16, and then 1 class every other week during weeks 17-24. Classes include tai chi warm-up exercises, breathing exercises, review and practice of tai chi forms, and cool-down exercises. Participants will be asked to practice tai chi at home 3x per week during the 6 month intervention period using an instructional video provided to them. The Fitbit fitness tracker will be given to each participant along with instructions on how to use the tracker and the Fitbit app on their personal device.
    Primary Outcome Measure Information:
    Title
    Recruitment rate
    Description
    Recruitment rate will be evaluated with respect to rate of enrollment, defined as randomization into the trial.
    Time Frame
    Through study completion (an average of 3 years)
    Title
    Retention rate
    Description
    Retention rate will be quantified by the proportion of subjects who remain in the study to complete our 9-month visit.
    Time Frame
    Through study completion (an average of 3 years)
    Title
    Intervention enjoyment
    Description
    Intervention enjoyment will be assessed via qualitative interviews
    Time Frame
    6 months
    Title
    Intervention adherence
    Description
    Intervention adherence will be measured by collection of class attendance and home practice data.
    Time Frame
    Through study completion (an average of 3 years)
    Secondary Outcome Measure Information:
    Title
    Physical activity
    Description
    Physical activity will be measured using accelerometers (Actigraph model wGT3X-BT, LLC, Fort Walton Beach, FL).
    Time Frame
    Baseline, 6 and 9 months
    Title
    Systolic and diastolic blood pressure
    Description
    Blood pressure will be measured using a Dinamap XL automated BP monitor according to current recommendations.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Body weight
    Description
    Body weight will be measured using an electronic scale.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Height
    Description
    Height will be measured using a tape measure.
    Time Frame
    Baseline
    Title
    Fasting glucose
    Description
    Fasting glucose will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Lipid panel
    Description
    Lipid panel will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    Time Frame
    Baseline, 6 and 9 months
    Title
    hs-CRP
    Description
    hs-CRP will be measured after a 12-hour fast according to standardized procedures. All blood samples will be sent to and analyzed at the Lifespan Laboratory located at the Rhode Island Hospital/The Miriam Hospital.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Quality of life assessed by SF-36
    Description
    Quality of life will be measured using a short version (8 items) of the Health Survey Short Form (SF-36). Scores range from 0-100, with a higher score indicating a higher quality of life.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Intrinsic motivation
    Description
    Intrinsic Motivation Inventory is a 22-item scale validated with four sub-scales: interest/enjoyment, perceived competence, perceived choice, and pressure/tension. A higher score is better, with a scoring range of 22-154.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Anxiety, Depression
    Description
    Anxiety, Depression will be assessed using the Hospital Anxiety and Depression Scale, a self-administered questionnaire with two sub-scales (0-21) measuring anxiety and depression, with higher scores indicating greater psychological morbidity.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Stress
    Description
    Stress will be measured using the Perceived Stress Scale (PSS) - a 10 items survey with scores ranging from 0 to 40, and higher scores indicating greater stress burden.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Mindful awareness
    Description
    Mindful awareness will be assessed using the Five Facets of Mindfulness questionnaire (short form) a 15-item questionnaire that measures the five identified components of mindfulness meditation: observing, acting with awareness, non-judging of inner experience, and non-reactivity to inner experience. Scores ranges from 39-19, with a higher score being better.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Exercise self-efficacy
    Description
    Exercise self-efficacy will be measured using the Self-Efficacy for Exercise Scale. This is a 9-item validated scale from McAuley's original barriers scale. Scores range form 9-28, with a higher score meaning more self-efficacy.
    Time Frame
    Baseline, 6 and 9 months
    Title
    Exercise capacity
    Description
    Exercise capacity will be assessed via the 6 min walk test (6MWT), a simple, safe and reliable first-line assessment of functional status that correlates with peak oxygen uptake.
    Time Frame
    Baseline, 6 and 9 months
    Other Pre-specified Outcome Measures:
    Title
    Socio-demographics
    Description
    Age, sex, race/ethnicity, education, income, insurance status will be collected from the EMR using standard abstraction forms.
    Time Frame
    Baseline
    Title
    Medical history
    Description
    Coronary risk factors; coronary revascularization procedures; ejection fraction; New York Heart Association class; CHD severity (one-, two- or three-vessel from coronary angiogram); co-morbidities; CR information (history of participation, reasons for decline); comorbidities (Charlson index); medications] will be abstracted from medical records using standard abstraction forms that have been validated in previous studies.
    Time Frame
    Baseline
    Title
    Social support
    Description
    Social support will be measured with the Multidimensional Scale of Perceived Social Support is a 12-item, unidimensional tool to measure how one perceives their social support system, including the individual's sources of social support (i.e., family, friends, and significant others). Scores range from 12-84, with a higher score meaning more perceived social support.
    Time Frame
    Baseline
    Title
    Neighborhood barriers to physical activity
    Description
    PANES (Physical Activity Neighborhood Environment Survey) also known as the International Physical Activity Prevalence Study Self-Administered Environmental Module is a 17-item Scale that can be used to assess the environmental factors for walking and bicycling in various neighborhoods. Scores range from 17-68, with higher scores indicating a neighborhood environment that is more conducive to physical activity.
    Time Frame
    Baseline

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: History of ACS (unstable angina, NSTEMI, and STEMI, defined per current AHA/ACC criteria); Age ≥ 18; Being physically inactive (i.e., < 150 min/week of moderate-intensity aerobic PA); Absence of contraindications to physical exercise per the participant's provider evaluation; Access to a digital device with internet connection; Having an active email account and ability to check email at least weekly; Physician clearance to participate in low-moderate intensity exercise (tai chi), including a statement that there is no contraindication to exercise based on post-ACS stress test and other factors, as appropriate; English speaking Exclusion Criteria: Inability or unwillingness to give informed consent; Blood pressure >200/110 or orthostatic systolic blood pressure decrease >20 mmHg at the baseline visit; Uncontrolled/untreated atrial or ventricular arrhythmias or 3rd degree AV block; Within 3 months of a diagnosis of pericarditis or myocarditis; Medical conditions likely to limit lifespan to less than one year; New York Heart Association (NYHA) functional class IV; Severe cognitive impairment (BOMC >10);139 Orthopedic problems prohibiting TC practice; Ongoing TC or other mind-body training (i.e., meditation, TC, or yoga) at least weekly; Current enrollment in cardiac rehabilitation; Untreated severe depression (PHQ>=20); Conditions likely to affect study compliance (i.e., moving out of study area, substance use, ongoing untreated psychosis); Symptoms of unstable cardiovascular disease (e.g., shortness of breath or chest pain at rest and/or Canadian Cardiovascular Society Angina Class III-IV)
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Daniel Litrownik, BA
    Phone
    617-754-1423
    Email
    dlitrown@bwh.harvard.edu

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Online Tai Chi Plus Fitbit After ACS

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