The Gentle Cardiac Rehabilitation Study

August 14, 2018 updated by: Elena Salmoirago-Blotcher, The Miriam Hospital

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
33

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Rhode Island
      • Providence, Rhode Island, United States, 02906
        • The Miriam Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 90 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Able to understand and speak English
  2. Age ≥21
  3. Physically inactive
  4. Ability to understand the study procedures and willingness to commit to the demands of the study protocol

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Other: high dose tai chi intervention
Behavioral: PLUS
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
Other: standard dose tai chi intervention
Behavioral: LITE
1 hour tai chi session 3 times a week (weeks 1-12)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
retention rates
Time Frame: up to 9 months since enrollment
up to 9 months since enrollment
drop-out rates
Time Frame: up to 9 months since enrollment
up to 9 months since enrollment
tai chi class attendance rates
Time Frame: up to 6 months since enrollment
up to 6 months since enrollment
number of participants with severe and non severe adverse events
Time Frame: up to 9 months since enrollment
up to 9 months since enrollment
percentage of participants reporting intervention acceptability scores in highest quartile
Time Frame: 3, 6, and 9 months since enrollment
3, 6, and 9 months since enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
baseline, 3, 6, 9 months

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Time Frame
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
baseline, 3,6, and 9 months
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
baseline, 3, 6, and 9 months
change from baseline aerobic capacity (METs)
Time Frame: baseline and intervention completion
baseline and intervention completion
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
baseline, 3,6,9 months
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
baseline, 3,6, and 9 months
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
baseline, 3, 6, 9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Miriam Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institutes of Health (NIH)
National Center for Complementary and Integrative Health (NCCIH)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 11, 2014

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2014

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 17, 2014

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 16, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 14, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • R34AT007569 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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