Long-term exercise after pulmonary rehabilitation (LEAP): design and rationale of a randomized controlled trial of Tai chi.

Author: Moy ML1, Wayne PM2, Litrownik D3, Beach D4, Klings ES5, Davis RB6, Yeh GY7.
Affiliation: 1Pulmonary and Critical Care Medicine Section, Department of Medicine, Veterans Administration Boston Healthcare System, Boston, MA, USA. Electronic address: marilyn.moy@va.gov. 2Osher Center for Integrative Medicine, Brigham and Women's Hospital and Harvard Medical School, Boston, MA,USA; Division of Preventive Medicine, Brigham and Women's Hospital, Boston, MA, USA. Electronic address: pwayne@partners.org. 3Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: dlitrown@bidmc.harvard.edu. 4Division of Pulmonary, Sleep and Critical Care Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA. Electronic address: dbeach@bidmc.harvard.edu. 5The Pulmonary Center, Boston University School of Medicine, Boston, MA, USA. Electronic address: klingon@bu.edu. 6Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: rdavis@bidmc.harvard.edu. 7Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: gyeh@hms.harvard.edu.
Conference/Journal: Contemp Clin Trials.
Date published: 2015 Sep 8
Other: Pages: S1551-7144(15)30082-3 , Special Notes: doi: 10.1016/j.cct.2015.09.004. , Word Count: 280


Abstract
BACKGROUND:
Persons with chronic obstructive pulmonary disease (COPD) have reduced exercise capacity and levels of physical activity. Supervised, facility-based pulmonary rehabilitation programs improve exercise capacity and reduce dyspnea, but novel long-term strategies are needed to maintain the benefits gained. Mind-body modalities such as Tai Chi which combine aerobic activity, coordination of breathing, and cognitive techniques that alleviate the physical inactivity, dyspnea, and anxiety and depression that are the hallmarks of COPD are promising strategies.
METHODS/DESIGN:
We have designed a randomized controlled study to examine whether Tai Chi will maintain exercise capacity in persons with COPD who have recently completed a supervised pulmonary rehabilitation program, compared to standard care. The primary outcome is 6-min walk test distance at 6months. Secondary outcomes include health-related quality of life, dyspnea, mood, occurrence of acute exacerbations, engagement in physical activity, exercise self-efficacy, and exercise adherence. Simultaneously, we are conducting a pilot study of group walking. We will enroll 90 persons who will be randomized to one of 3 arms in a 2:2:1 ratio: Tai Chi, standard care, or group-based walking.
DISCUSSION:
The Long-term Exercise After Pulmonary Rehabilitation (LEAP) study is a novel and clinically relevant trial. We will enroll a well-characterized cohort of persons with COPD and will comprehensively assess physiological and psychosocial outcomes. Results of this study will provide the evidence base for persons with COPD to engage in Tai Chi as a low-cost, long-term modality to sustain physical activity in persons who have completed a standard short-term pulmonary rehabilitation program.
TRIAL REGISTRATION:
This trial is registered in Clinical Trials.gov, with the ID number of NCT01998724.
Copyright © 2015. Published by Elsevier Inc.
KEYWORDS:
Chronic obstructive pulmonary disease; Exercise; Mind-body therapies; Physical activity; Pulmonary rehabilitation
PMID: 26362690