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In this prospective cohort study the investigators aim to evaluate the effect of pulmonary rehabilitation on sleep quality. Disturbed sleep is associated with, frequent exacerbations, increase in the severity of disease and increased mortality in chronic obstructive pulmonary disease (COPD). Sleep quality is a good predictor of quality of life in patients with stable COPD. However, there has been little investigation into non-pharmacological methods to improve sleep quality in patients with COPD and heart failure. It is also uncertain, how long the beneficial effects of cardio-pulmonary rehabilitation on sleep quality, if any, usually last. Due to lack of robust data, the investigators sought to find the effect of cardio-pulmonary rehabilitation on sleep quality.
Sleep disorders including poor quality of sleep are common in patients with heart failure, chronic obstructive pulmonary disease (COPD) and, possibly, other chronic lung disorders. These patients complain of difficulty sleeping and sleep fragmentation, often related to symptoms such as cough, sputum production or shortness of breath. Patients with COPD and heart failure commonly have other abnormalities such as nocturnal oxygen desaturation that may further worsen sleep disturbances. Moreover, sleep disordered breathing (SDB), like obstructive sleep apnea syndrome (OSA), has been linked to higher morbidity and mortality if COPD is present (known as Overlap syndrome). In patients with COPD and heart failure, cardio-pulmonary rehabilitation has important health benefits such as improvement in disease related symptoms, exercise tolerance, and health-related quality of life. However, the effect of cardio-pulmonary rehabilitation on sleep quality is controversial. Disturbed sleep is associated with frequent exacerbations, increase in the severity of disease and increased mortality in COPD and heart failure patients.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cardiopulmonary rehabilitation | Other | Patients will undergo standardized cardio-pulmonary rehabilitation program. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index | Pittsburgh sleep quality index is validated questionnaire and will be used to determine improvement in sleep quality before and after completion of cardiopulmonary rehabilitation. Pittsburgh sleep quality index comprises of seven components. Each component is marked from 0 to 3, with a maximum total score of 21 and a minimum total score of 0. A score of less than 5 indicates good overall sleep quality and a score of 5 and more indicates poor sleep quality. From literature review using Pittsburgh sleep quality index, minimal clinically important difference was determined to be 3 between before and after measurements. | 8 weeks on average |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Insomnia Severity Index | Insomnia severity index will be determined before and after cardiopulmonary rehabilitation. Insomnia severity index consists of 7 items with a minimum total score of 0 and maximum total score of 28 with a score of 8 or more suggesting presence of insomnia. A 6 point change is considered significant (minimum significant important difference) as determined by literature. Paired student t-test will be used to compare means before and after cardio-pulmonary rehabilitation |
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Inclusion Criteria:
Exclusion Criteria:
• Not meeting inclusion criteria
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Setting: Outpatient
The study cohort will include patients will chronic lung and heart diseases who meet the inclusion criteria and are to undergo cardiopulmonary rehabilitation in a safety net hospital.
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| Name | Affiliation | Role |
|---|---|---|
| Vidya Krishnan, MD | MetroHealth Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Metrohealth medical center | Cleveland | Ohio | 44109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23514215 | Background | 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. | |
| 22429651 | Background | 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. |
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No current plan to share individual participant data at this time.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Baseline to Completion of Rehab |
| |||||||||||||
| Completion of Rehab to 3-Month Followup |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | What scale measures: age, in years, from time of birth to start of pulmonary rehabilitation Scale range: 18 thru 110 (in years) What numbers mean on range: age, in years, from time of birth to start of pulmonary rehabilitation Purpose of the scale: report age of patient (a known risk factor for sleep disordered breathing) |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index | Pittsburgh sleep quality index is validated questionnaire and will be used to determine improvement in sleep quality before and after completion of cardiopulmonary rehabilitation. Pittsburgh sleep quality index comprises of seven components. Each component is marked from 0 to 3, with a maximum total score of 21 and a minimum total score of 0. A score of less than 5 indicates good overall sleep quality and a score of 5 and more indicates poor sleep quality. From literature review using Pittsburgh sleep quality index, minimal clinically important difference was determined to be 3 between before and after measurements. | those who completed PR (8 weeks) | Posted | Mean | Standard Deviation | units on a scale | 8 weeks on average |
|
Eight weeks + 3 months. the eight weeks represents the duration of the pulmonary rehabilitation, and the additional 3 months is the follow-up after pulmonary rehabilitation.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Rehab moved from main campus to off-site, limiting our ability to recruit more patients.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vidya Krishnan | The MetroHealth | 2167784527 | vkrishnan@metrohealth.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 5, 2021 | Jul 26, 2024 | Prot_003.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2020 | Apr 13, 2023 | SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 10, 2020 | May 4, 2023 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D009202 | Cardiomyopathies |
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| 8 weeks. |
| 21311688 | Background | 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. |
| 9178916 | Background | 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. |
| 25010602 | Background | 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. |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | What scale measures: sex assigned at birth Scale range: Male, Female What numbers mean on range: N/a Purpose of the scale: report sex assigned at birth (a known risk factor for sleep disordered breathing) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | What scale measures: ethnicity, as reported by patient Scale range: Hispanic or Latino / not Hispanic or Latino, Unknown or Not Reported What numbers mean on range: N/a Purpose of the scale: report ethnicity to see if it might be a factor that affects the impact of pulmonary rehabilitation on sleep outcomes | Count of Participants | Participants |
|
| Race (NIH/OMB) | What scale measures: race as reported by patient Scale range: American Indian or Alaska Native, Asian, native Hawaiian or other pacific slander, Black or African American, White, more than one race, Unknown or not reported What numbers mean on range: N/a Purpose of the scale: report race to see if it may be a factor on the association of pulmonary rehabilitation and sleep outcomes | Count of Participants | Participants |
|
| Body-Mass Index (BMI) | What scale measures: body mass index, as measured during first session of pulmonary rehabilitation Scale range: 15 to 100 kg/m2 What numbers mean on range: calculated body mass index based on height and weight. Purpose of the scale: report body mass index, a known risk factor for sleep disordered breathing. | Mean | Standard Deviation | kg/m2 |
|
| Epworth Sleepiness Scale | What scale measures: reported sleepiness of patient in passive and active scenarios. Scale range: 0 through 24 What numbers mean on range: higher numbers indicated more sleepiness. Epworth > 10 is considered pathologically sleepy. Purpose of the scale: report patient-reported sleepiness to see if it correlates with any objective measures of sleep outcomes. | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Patients Who Completed Rehab and 3-month Followup (5 Months) | patients who completed pulmonary rehabilitation and 3-month followup - this would be the 8 weeks of rehab plus 3 months so 5 months in total |
|
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| Secondary | Change in Insomnia Severity Index | Insomnia severity index will be determined before and after cardiopulmonary rehabilitation. Insomnia severity index consists of 7 items with a minimum total score of 0 and maximum total score of 28 with a score of 8 or more suggesting presence of insomnia. A 6 point change is considered significant (minimum significant important difference) as determined by literature. Paired student t-test will be used to compare means before and after cardio-pulmonary rehabilitation | Posted | Mean | Standard Deviation | units on a scale | 8 weeks. |
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| 0 |
| 106 |
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| 106 |
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| 106 |
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