Clinical Trials Directory

Trials / Completed

CompletedNCT02165254

The Gentle Cardiac Rehabilitation Study

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
33 (actual)
Sponsor
The Miriam Hospital · Academic / Other
Sex
All
Age
21 Years – 90 Years
Healthy volunteers
Not accepted

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.

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.

Conditions

Interventions

TypeNameDescription
BEHAVIORALPLUS1 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
BEHAVIORALLITE1 hour tai chi session 3 times a week (weeks 1-12)

Timeline

Start date
2014-10-01
Primary completion
2016-08-01
Completion
2016-12-01
First posted
2014-06-17
Last updated
2018-08-16

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT02165254. Inclusion in this directory is not an endorsement.