Cardio-pulmonary Rehabilitation and Sleep Quality

Heart Failure Clinical Trial

Official title:

Cardio-pulmonary Rehabilitation and Its Impact on Sleep Quality; a Prospective Analysis

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04668599
• Other study ID #: IRB19-00906
• Status: Active, not recruiting
• Start date: May 11, 2020
• Est. completion date: October 11, 2024

Study information

• Verified date: December 2023
• Source: MetroHealth Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: October 11, 2024
• Est. primary completion date: October 11, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• 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.

Exclusion Criteria:

• Not meeting inclusion criteria

Related Conditions & MeSH terms

• Cardiomyopathies
• Heart Failure
• Lung Diseases
• Lung Diseases, Obstructive
• Obstructive Pulmonary Disease
• Restrictive Lung Disease

Intervention

Other:
• Cardiopulmonary rehabilitation
Patients will undergo standardized cardio-pulmonary rehabilitation program.

Locations

Country	Name	City	State
United States	Metrohealth medical center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
MetroHealth Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (5)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	8 weeks on average
Primary	Sleep apnea screening using Berlin questionnaire.	Berlin questionnaire will be used to screen for sleep apnea in individuals who are to begin cardiopulmonary rehabilitation and do not have a known diagnosis of sleep apnea. Investigators will specifically look for the percentage of patients who are at high risk for sleep apnea based on Berlin questionnaire (positive score on 2 out of 3 categories of the questionnaire) in the cardio-pulmonary cohort.	Through study completion which is approximately one year.
Secondary	Effect of cardio-pulmonary rehabilitation on disease specific health related quality of life.	Hospital anxiety and depression scale is self-reported questionnaire tool to screen for anxiety and depression with two subscales (one of anxiety and one for depression). Each subscale has a minimum score of 0 and maximum score of 21. A cut-off of 11 or more indicates probable mood disorder.; COPD assessment test will be used for COPD patients. COPD assessment test consists of 8 items with a minimum score of 0 and a maximum score of 40. A score of 10 or more suggests presence of significant lung disease.; Kansas city cardiomyopathy questionnaire consists of 23 items with a minimum score of 0 and a maximum score of 100. A score of less than 25 signifies presence of poor heart function.; Change in mean scores before and after rehabilitation will be determined and paired student t-test will be used to determine if the change in scores is significant.	8 weeks
Secondary	Correlation between sleep quality and disease specific health related quality of life.	Correlation between change in disease specific health status as determined by the questionnaires (HADS, CAT and KCCQ) after cardio-pulmonary rehabilitation and change in sleep quality as determined by Pittsburgh sleep quality index will be determined by using Pearson's correlation coefficient (r).	8 weeks
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	8 weeks.
Secondary	Longevity of sleep improvement	Pittsburgh sleep quality index questionnaire will be administer 3-months after completion of cardio-pulmonary rehabilitation if there is improvement in sleep quality at the end of cardio-pulmonary rehabilitation. The mean scores from end of rehabilitation and 3-months after completion of cardio-pulmonary rehabilitation will be compared using paired student t-test.	3 months.