Secondary Prevention of Coronary Heart DiseaseNCT02165254
The Gentle Cardiac Rehabilitation Study
A study testing PLUS and LITE in people with Secondary Prevention of Coronary Heart Disease, run by The Miriam Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 90 years
- Conditions the study is for
- Secondary Prevention of Coronary Heart Disease
- What is being tested?
- PLUS and LITE
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2014to Dec 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Being tested
- PLUS, LITE
- Keywords
- physical activity, coronary heart disease, exercise, affect, mind/body therapies, stress, psychological
- Medical subject headings
- Motor Activity, Coronary Disease, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PLUSBehavioural
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
LITEBehavioural
1 hour tai chi session 3 times a week (weeks 1-12)
| Study group | Role | What they receive |
|---|---|---|
| high dose tai chi intervention | Other | Not described Receives: Behavioral: PLUS |
| standard dose tai chi intervention | Other | Not described Receives: Behavioral: LITE |
What is being measured
The primary outcome is the main question the study is designed to answer.
retention rates
Measured: up to 9 months since enrollment
drop-out rates
Measured: up to 9 months since enrollment
tai chi class attendance rates
Measured: up to 6 months since enrollment
number of participants with severe and non severe adverse events
Measured: up to 9 months since enrollment
percentage of participants reporting intervention acceptability scores in highest quartile
Measured: 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)
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.
Measured: baseline, 3, 6, 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2014 (estimated)
- Study startOct 2014
- Primary completionAug 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Secondary Prevention of Coronary Heart DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Miriam Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Principal investigator, Elena Salmoirago-Blotcher, The Miriam Hospital
- Investigators
- Elena Salmoirago-Blotcher, PhD, MD, Principal investigator, The Miriam Hospital & Warren Alpert Medical School at Brown University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02165254
- Sponsor's protocol ID
- R34AT007569
- Other IDs
- R34AT007569
- Status last verified
- Aug 2018
- First submitted
- 11 Jun 2014
- Last updated
- 16 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Salmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation. Contemp Clin Trials. 2015 Jul;43:243-51. doi: 10.1016/j.cct.2015.06.020. Epub 2015 Jun 24.
PubMed 26115880Salmoirago-Blotcher E, Wayne PM, Dunsiger S, Krol J, Breault C, Bock BC, Wu WC, Yeh GY. Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation. J Am Heart Assoc. 2017 Oct 11;6(10):e006603. doi: 10.1161/JAHA.117.006603.
PubMed 29021268
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of A Tai-Chi Program To Overcome Barriers To Cardiac Rehabilitation
- ClinicalTrials.gov ID
- NCT02165254
- Acronym / sponsor ID
- R34AT007569
- Keywords
- physical activity, coronary heart disease, exercise, affect, mind/body therapies, stress, psychological
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- The Miriam HospitalUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), National Center for Complementary and Integrative Health (NCCIH)
- Study start
- Oct 2014 (actual)
- Primary completion
- Aug 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 17 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high dose tai chi intervention | Other | Behavioral: PLUS |
| standard dose tai chi intervention | Other | Behavioral: LITE |
Who may qualify
- Ages
- 21 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PLUS1 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 | Behavioural | high dose tai chi intervention |
| LITE1 hour tai chi session 3 times a week (weeks 1-12) | Behavioural | standard dose tai chi intervention |
Primary outcome
retention rates
Time frame: up to 9 months since enrollment
drop-out rates
Time frame: up to 9 months since enrollment
tai chi class attendance rates
Time frame: up to 6 months since enrollment
number of participants with severe and non severe adverse events
Time frame: 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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2018.
- Background: PubMed 26115880Salmoirago-Blotcher E, Wayne P, Bock BC, Dunsiger S, Wu WC, Stabile L, Yeh G. Design and methods of the Gentle Cardiac Rehabilitation Study--A behavioral study of tai chi exercise for patients not attending cardiac rehabilitation. Contemp Clin Trials. 2015 Jul;43:243-51. doi: 10.1016/j.cct.2015.06.020. Epub 2015 Jun 24.
- Results publication: PubMed 29021268Salmoirago-Blotcher E, Wayne PM, Dunsiger S, Krol J, Breault C, Bock BC, Wu WC, Yeh GY. Tai Chi Is a Promising Exercise Option for Patients With Coronary Heart Disease Declining Cardiac Rehabilitation. J Am Heart Assoc. 2017 Oct 11;6(10):e006603. doi: 10.1161/JAHA.117.006603.
Related trials for Secondary Prevention of Coronary Heart Disease
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The Norwegian Trial of Physical Exercise After Myocardial Infarction
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Effectiveness of the "Aktivplan" Digital Intervention for Supporting Regular Heart-Healthy Physical Activity Following Phase II Cardiac Rehabilitation
Cardiovascular Diseases (CVD)
Recruiting
Evaluation of a Remote Behavioural Stress Recovery Intervention for Myocardial Infarction Patients Younger Than Fifty-five (BRIM-55): A Feasibility Study
Cardiac Disease, Depression and Quality of Life
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DAN-RELEASE - Reconsidering Long-Term Aspirin in the Elderly Patients With Stable Ischemic Heart Disease
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Not yet recruitingPhase 4
Reconsidering Long-Term Apirin in the Elderly in Secondary Prevention of Coronary Artery Disease Norway
Coronary Arterial Disease (CAD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Salmoirago-Blotcher, PhD, MD principal investigator
The Miriam Hospital & Warren Alpert Medical School at Brown University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PLUS and LITE in people with Secondary Prevention of Coronary Heart Disease, run by The Miriam Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
retention rates (time frame: up to 9 months since enrollment). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02165254, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Aug 2018.