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Completed

NCT Number: NCT01998724

Tai Chi After Pulmonary Rehabilitation in Patients With COPD: A Randomized Trial

The main purpose of this study is to determine the feasibility and effects of a 6-month tai chi exercise program as compared to a 6-month group walking program and standard care for patients with COPD that have recently completed a pulmonary rehabilitation program.

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Key information

Conditions

Chronic Obstructive Pulmonary Disease (COPD) Bronchial Diseases Bronchitis Bronchitis, Chronic Chronic Disease Disease Attributes Emphysema Infections Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Respiratory Tract Infections

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Beth Israel Deaconess Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • COPD defined as FEV1 (Forced expiratory volume in 1 second)/FVC (Forced vital capacity) <0.70 or chest CT evidence of emphysema
  • Age > 40 years
  • Any severity of COPD as defined by GOLD (Global Obstructive Lung Disease) stages 1, 2,3, or 4
  • Completion of standard pulmonary rehabilitation of at least 8 weeks duration within 24 weeks prior to study entry* *Defined as attending 65% of the program's sessions with a minimum of 10 sessions

Exclusion criteria

  • COPD exacerbation requiring steroids, antibiotics, ED visit or hospitalization within the past 2 weeks unless physician deems subject at baseline
  • Hypoxemia on walk test (O2 sat < 85% on oxygen)
  • Inability to ambulate due to vascular or other neuromuscular conditions that would preclude a walk test
  • Clinical signs of unstable cardiovascular disease (ie. chest pain on walk test)
  • Severe cognitive dysfunction (documented Mini-Mental Status Exam ≤ 24)
  • Non-English speaking
  • Current regular practice of tai chi
  • Current diagnosis of lung cancer or treated for lung cancer within the past 5 years
  • Unstable/untreated mental health issue that precludes informed consent or otherwise affects ability to participate in the intervention

Treatment and study plan

Tai Chi

Behavioral

24 week tai chi intervention designed for individuals with COPD

Group Walking

Behavioral

24 week group walking intervention

Primary outcomes

  1. Feasibility of tai chi intervention

    Time frame: 24 weeks

    Willingness to participate, adherence, and safety

Secondary outcomes

  1. Change from baseline - Disease specific quality of life

    Time frame: Baseline, 12 weeks, 24 weeks, 1 year

    Chronic Respiratory Questionnaire

  2. Change from baseline - Exercise capacity

    Time frame: Baseline, 12 weeks, 24 weeks

    Six minute walk distance

  3. Change from baseline - Dyspnea

    Time frame: Baseline, 12 weeks, 24 weeks, 1 year

    University of California, San Diego Shortness of Breath Questionnaire

  4. Change from baseline - Psychosocial well-being

    Time frame: Baseline, 12 weeks, 24 weeks, 1 year

    Center for Epidemiologic Studies Depression Scale, Perceived Stress Scale, COPD Self-Efficacy Scale, Multidimensional Scale of Perceived Social Support

  5. Changes from baseline - Pulmonary function

    Time frame: Baseline, 12 weeks, 24 weeks

    Spirometry

  6. Change from baseline - Exercise Efficacy

    Time frame: Throughout study

    Daily exercise activities, step counts taken at baseline, 12 weeks, 24 weeks, 1 year

Sponsors and collaborators

Lead sponsor

Beth Israel Deaconess Medical Center

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)
  • National Institutes of Health (NIH)

Registry information

Acronym: LEAP

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Dec 2, 2013
Registry last updated
Oct 3, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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