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| Tracking Information | |||||
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| First Received Date ICMJE | January 16, 2003 | ||||
| Last Updated Date | August 16, 2006 | ||||
| Start Date ICMJE | January 2003 | ||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE | |||||
| Change History | Complete list of historical versions of study NCT00051792 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Yoga for Treating Shortness of Breath in Chronic Obstructive Pulmonary Disease (COPD) | ||||
| Official Title ICMJE | Efficacy of Yoga for Self-Management of Dyspnea in COPD | ||||
| Brief Summary | The purpose of this study is to evaluate the safety and effectiveness of yoga in reducing shortness of breath in people with chronic obstructive pulmonary disease (COPD). Patients in this study must have moderate to severe COPD and be primarily limited by shortness of breath. |
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| Detailed Description | Management of dyspnea (shortness of breath) is a major concern for patients with COPD. The efficacy of complementary exercises to manage dyspnea is unknown. Complementary exercises may be more congruent with patients' lifestyles and values than traditional exercise programs and can be adapted to changes in illness severity and disability. Yoga practice is a complementary therapy that people use to manage their dyspnea. The aims of this study are to: 1) develop a safe and feasible yoga program for patients with COPD; 2) test the efficacy of this program; and 3) determine whether physical performance, psychological well being, and health-related quality of life are positively affected by yoga practice. Patients in this study will be randomized to receive yoga training or usual care for 12 weeks. Patients will be evaluated at study entry, after each session, and immediately after the training program. |
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| Study Phase | Phase I, Phase II | ||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study | ||||
| Condition ICMJE |
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| Intervention ICMJE | Behavioral: yoga | ||||
| Study Arms / Comparison Groups | |||||
| Publications * | |||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 36 | ||||
| Completion Date | July 2004 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion criteria:
Exclusion criteria:
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| Gender | Both | ||||
| Ages | 40 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00051792 | ||||
| Responsible Party | |||||
| Study ID Numbers ICMJE | R21 AT001168-01 | ||||
| Study Sponsor ICMJE | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | National Center for Complementary and Alternative Medicine (NCCAM) | ||||
| Verification Date | August 2006 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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