Study Results
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View full resultsBasic Information
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COMPLETED
106 participants
OBSERVATIONAL
2020-05-11
2024-10-11
Brief Summary
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Detailed Description
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The investigators hypothesize that cardio-pulmonary rehabilitation results in improved sleep quality in patients with chronic lung disease and heart failure, this may be an important contributor to improved health outcomes after completion of cardio-pulmonary rehabilitation program.
The study will use data from questionnaires filled by the patients before and after completion of cardio-pulmonary rehabilitation. A 3-month follow up survey using the same questionnaires will be conducted to determine the longevity of improved sleep quality (if present). The questionnaires that will be used include Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS), Berlin questionnaire, COPD assessment test (CAT) for COPD patients, Kansas city cardiomyopathy questionnaire (KCCQ) for heart failure patients, hospital induced anxiety and depression scale (HADS) and insomnia severity index (ISI).
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Patient with chronic lung or cardiac diseases
This study will focus on patients with obstructive or restrictive lung diseases eligible for pulmonary rehabilitation.
Patient with cardiac disease such as heart failure, coronary artery disease or cardiomyopathies who are eligible for cardiac rehabilitation will also be included.
Cardiopulmonary rehabilitation
Patients will undergo standardized cardio-pulmonary rehabilitation program.
Interventions
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Cardiopulmonary rehabilitation
Patients will undergo standardized cardio-pulmonary rehabilitation program.
Eligibility Criteria
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Inclusion Criteria
* Patient who are willing to participate in follow-up survey 3 months after completion of pulmonary rehabilitation.
* Patients who complete rehabilitation for at least 8 weeks.
18 Years
ALL
No
Sponsors
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MetroHealth Medical Center
OTHER
Responsible Party
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Vidya Krishnan
Professor, Case Western Reserve University.
Principal Investigators
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Vidya Krishnan, MD
Role: PRINCIPAL_INVESTIGATOR
MetroHealth Medical Center
Locations
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Metrohealth medical center
Cleveland, Ohio, United States
Countries
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References
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Soler X, Diaz-Piedra C, Ries AL. Pulmonary rehabilitation improves sleep quality in chronic lung disease. COPD. 2013 Apr;10(2):156-63. doi: 10.3109/15412555.2012.729622. Epub 2013 Mar 20.
Omachi TA, Blanc PD, Claman DM, Chen H, Yelin EH, Julian L, Katz PP. Disturbed sleep among COPD patients is longitudinally associated with mortality and adverse COPD outcomes. Sleep Med. 2012 May;13(5):476-83. doi: 10.1016/j.sleep.2011.12.007. Epub 2012 Mar 18.
Scharf SM, Maimon N, Simon-Tuval T, Bernhard-Scharf BJ, Reuveni H, Tarasiuk A. Sleep quality predicts quality of life in chronic obstructive pulmonary disease. Int J Chron Obstruct Pulmon Dis. 2010 Dec 22;6:1-12. doi: 10.2147/COPD.S15666.
Youngstedt SD, O'Connor PJ, Dishman RK. The effects of acute exercise on sleep: a quantitative synthesis. Sleep. 1997 Mar;20(3):203-14. doi: 10.1093/sleep/20.3.203.
McDonnell LM, Hogg L, McDonnell L, White P. Pulmonary rehabilitation and sleep quality: a before and after controlled study of patients with chronic obstructive pulmonary disease. NPJ Prim Care Respir Med. 2014 Jul 10;24:14028. doi: 10.1038/npjpcrm.2014.28.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB19-00906
Identifier Type: -
Identifier Source: org_study_id
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