The Gentle Cardiac Rehabilitation Study

NCT02165254 | Completed DMC

• 1 other identifier: R34AT007569
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Prevention of Coronary Heart Disease

Keywords

physical activity; coronary heart disease; exercise; affect; mind/body therapies; stress, psychological

Outcome Measures

Primary Outcomes (5)

• retention rates

  up to 9 months since enrollment

• drop-out rates

  up to 9 months since enrollment

• tai chi class attendance rates

  up to 6 months since enrollment

• number of participants with severe and non severe adverse events

  up to 9 months since enrollment

• percentage of participants reporting intervention acceptability scores in highest quartile

  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)

  baseline, 3, 6, 9 months

Other Outcomes (6)

• 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)

  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)

  baseline, 3, 6, and 9 months

• change from baseline aerobic capacity (METs)

  baseline and intervention completion

Study Arms (2)

high dose tai chi intervention

OTHER

Behavioral: PLUS

standard dose tai chi intervention

OTHER

Behavioral: LITE

Interventions

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

high dose tai chi intervention

LITE BEHAVIORAL

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

standard dose tai chi intervention

Eligibility Criteria

• Age: 21 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• The Miriam Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

The Miriam Hospital

Providence, Rhode Island, 02906, United States

Location

Related Publications (2)

• 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.

  PMID: 26115880 BACKGROUND

• Salmoirago-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.

  PMID: 29021268 RESULT

MeSH Terms

Conditions

Motor Activity; Coronary Disease; Stress, Psychological

Condition Hierarchy (Ancestors)

Behavior; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Behavioral Symptoms

Study Officials

• Elena Salmoirago-Blotcher, PhD, MD

  The Miriam Hospital & Warren Alpert Medical School at Brown University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: June 11, 2014
• First Posted: June 17, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 16, 2018

Record last verified: 2018-08

Locations

US (1)