title: Long-term Exercise After Pulmonary Rehabilitation (LEAP): Design and rationale of a randomized controlled trial of Tai Chi.
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
  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 6 months. 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 three arms in a 2:2:1 ratio: Tai Chi, standard care, or group-based walking.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  This trial is registered in Clinical Trials.gov, with the ID number of NCT01998724.
authors.affiliation: Pulmonary and Critical Care Medicine Section, Department of Medicine, Veterans Administration Boston Healthcare System, Boston, MA, USA. Electronic address: marilyn.moy@va.gov.
authors.forename: Marilyn L
authors.initials: ML
authors.lastname: Moy
authors.affiliation: Osher 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.
authors.forename: Peter M
authors.initials: PM
authors.lastname: Wayne
authors.affiliation: Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: dlitrown@bidmc.harvard.edu.
authors.forename: Daniel
authors.initials: D
authors.lastname: Litrownik
authors.affiliation: Division of Pulmonary, Sleep and Critical Care Medicine, Department of Medicine, Beth Israel Deaconess Medical Center, Boston, MA, USA. Electronic address: dbeach@bidmc.harvard.edu.
authors.forename: Douglas
authors.initials: D
authors.lastname: Beach
authors.affiliation: The Pulmonary Center, Boston University School of Medicine, Boston, MA, USA. Electronic address: klingon@bu.edu.
authors.forename: Elizabeth S
authors.initials: ES
authors.lastname: Klings
authors.affiliation: Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: rdavis@bidmc.harvard.edu.
authors.forename: Roger B
authors.initials: RB
authors.lastname: Davis
authors.affiliation: Division of General Medicine and Primary Care, Department of Medicine, Beth Israel Deaconess Medical Center, Brookline, MA, USA. Electronic address: gyeh@hms.harvard.edu.
authors.forename: Gloria Y
authors.initials: GY
authors.lastname: Yeh
mesh_terms: D000328:Adult; D000339:Affect; D000368:Aged; D004417:Dyspnea / Q000523:psychology / Q000534:rehabilitation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010349:Patient Compliance; D010809:Physical Fitness; D029424:Pulmonary Disease, Chronic Obstructive / Q000523:psychology / Q000534:rehabilitation*; D011788:Quality of Life; D012107:Research Design; D020377:Self Efficacy; D026302:Tai Ji / Q000379:methods* / Q000523:psychology
keywords: Chronic obstructive pulmonary disease; Exercise; Mind–body therapies; Physical activity; Pulmonary rehabilitation