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Completed

NCT Number: NCT02165254

The Gentle Cardiac Rehabilitation Study

The purpose of this study is to develop a tai-chi based exercise program designed for patients who recently had a heart attack and do not wish, or are unable, to attend traditional cardiac rehabilitation.

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Key information

Conditions

Secondary Prevention of Coronary Heart Disease Behavior Behavioral Symptoms Cardiovascular Diseases Coronary Disease Heart Diseases Motor Activity Myocardial Ischemia Stress, Psychological Vascular Diseases

Age range

21 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miriam Hospital

Providence, Rhode Island, 02906, United States

About this study

We will estimate the feasibility, acceptability and safety of two different doses of the Tai Chi intervention (primary outcome). 60 patients (30 per dose arm) will be randomly assigned to a standard dose of Tai Chi (the dose used by our group in large studies of heart failure patients) or to a high dose matching the recommended frequency and duration of exercise classes in current CRs. Acceptability assessments will include surveys and focus groups to formally assess the impact of Tai Chi on facilitators and barriers to CRs in this population. We will also obtain estimates of effect sizes of each dose on accelerometry measured physical activity and on the proportion of patients achieving the current American Heart Association (AHA) recommendation for physical activity (secondary outcome). Additional outcomes will be cardiac fitness, quality of life, body weight, and sleep. In addition, we will gather exploratory information on possible mechanisms by which Tai Chi training may affect physical activity. We will collect information on possible mediators such as exercise self-efficacy, perceived social support, and depression. In addition, since Tai Chi training is associated with meditative practices aimed at increasing present-moment awareness, we will gather information on mindfulness levels. Measurements will be conducted at baseline, 3-, 6-, and 9 months after enrollment.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Able to understand and speak English
  • Age ≥21
  • Physically inactive
  • Ability to understand the study procedures and willingness to commit to the demands of the study protocol

Exclusion criteria

  • Inability or unwillingness to give informed consent
  • Planning to move out of the area within the study period
  • Unstable angina
  • Blood pressure >200/110 or symptomatic orthostatic blood pressure decrease>20 mmHg
  • Uncontrolled atrial or ventricular arrhythmias; 3rd degree Atrio-Ventricular block
  • Pericarditis or myocarditis
  • Recent embolism/thrombophlebitis
  • Abnormal stress test without study cardiologist's clearance
  • Medical conditions likely to limit lifespan
  • NYHA functional class IV
  • Signs of cognitive impairment (BOMC >10)
  • Orthopedic problems prohibiting Tai Chi practice
  • Ongoing Tai Chi or other mind-body training
  • Current enrollment in a CR program
  • Severe depression (HADS scores>14)
  • Current drug or alcohol use or dependence that would interfere with adherence to study requirements.

Treatment and study plan

PLUS

Behavioral

1 hour tai chi session 3 times a week (weeks 1-12), to twice a week (week 13-16), and every other week (week 17-26) for a total of 24 weeks

LITE

Behavioral

1 hour tai chi session 3 times a week (weeks 1-12)

Primary outcomes

  1. retention rates

    Time frame: up to 9 months since enrollment

  2. drop-out rates

    Time frame: up to 9 months since enrollment

  3. tai chi class attendance rates

    Time frame: up to 6 months since enrollment

  4. number of participants with severe and non severe adverse events

    Time frame: up to 9 months since enrollment

  5. percentage of participants reporting intervention acceptability scores in highest quartile

    Time frame: 3, 6, and 9 months since enrollment

Secondary outcomes

  1. Mean between-group difference in within-participant change from baseline physical activity (accelerometry counts) over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3, 6, 9 months

    To estimate mean between-doses differences in physical activity (and other continuous secondary outcomes listed below), we will estimate multivariate linear mixed models for within-participant change since baseline as a function of dose group (high or low), time point (3, 6, and 9 months from enrollment, treated as a categorical variable to allow for non-linear trajectories), and their interaction. A statistically significant interaction indicates that between-group differences vary across time points.

Other outcomes

  1. Mean between-group difference in within-participant change from baseline Short Form-36 quality of life scores over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3,6, and 9 months

  2. Mean between-group difference in within-participant change from baseline HADS depression scores over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3, 6, and 9 months

  3. change from baseline aerobic capacity (METs)

    Time frame: baseline and intervention completion

  4. Mean between-group difference in within-participant change from baseline Pittsburg Sleep Quality Index scores over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3,6,9 months

  5. Mean between-group difference in within-participant change from baseline Five Facets of Mindfulness (FFM) scores over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3,6, and 9 months

  6. Mean between-group difference in within-participant change from baseline Multidimensional Scale of Perceived Social Support scores over time (3, 6, and 9 months from enrollment)

    Time frame: baseline, 3, 6, 9 months

Sponsors and collaborators

Lead sponsor

The Miriam Hospital

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Official study title

Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Jun 17, 2014
Registry last updated
Aug 16, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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