Cardio-pulmonary Rehabilitation and Sleep Quality

NCT04668599 | Completed Results DMC

• 1 other identifier: IRB19-00906
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Obstructive Pulmonary Disease; Cardiomyopathies; Heart Failure; Restrictive Lung Disease

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (1)

• Change in Insomnia Severity Index

  8 weeks.

Study Arms (1)

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.

Other: Cardiopulmonary rehabilitation

Interventions

Cardiopulmonary rehabilitation OTHER

Patients will undergo standardized cardio-pulmonary rehabilitation program.

Patient with chronic lung or cardiac diseases

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

Sponsors & Collaborators

• MetroHealth Medical Center: lead

Study Sites (1)

Metrohealth medical center

Cleveland, Ohio, 44109, United States

Location

Related Publications (5)

• 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.

  PMID: 23514215 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.

  PMID: 22429651 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.

  PMID: 21311688 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.

  PMID: 9178916 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.

  PMID: 25010602 BACKGROUND

MeSH Terms

Conditions

Lung Diseases, Obstructive; Cardiomyopathies; Heart Failure

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Heart Diseases; Cardiovascular Diseases

Limitations and Caveats

Rehab moved from main campus to off-site, limiting our ability to recruit more patients.

Results Point of Contact

• Title: Vidya Krishnan
• Organization: The MetroHealth

vkrishnan@metrohealth.org

2167784527

Study Officials

• Vidya Krishnan, MD

  MetroHealth Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Case Western Reserve University.

Study Record Dates

• First Submitted: October 7, 2020
• First Posted: December 16, 2020
• Study Start: May 11, 2020
• Primary Completion: October 11, 2024
• Study Completion: October 11, 2024
• Last Updated: November 5, 2024
• Results First Posted: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)