Obstructive Pulmonary DiseaseNCT04668599
Cardio-pulmonary Rehabilitation and Sleep Quality
An observational study of Obstructive Pulmonary Disease and Cardiomyopathies, run by MetroHealth Medical Center at 1 site in United States.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Obstructive Pulmonary Disease, Cardiomyopathies, Heart Failure
- What is being tested?
- Cardiopulmonary rehabilitation
- How many people
- 106 participants
- Where
- 1 siteUnited States
- Study dates
- 11 May 2020to 11 Oct 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- Not meeting inclusion criteria
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cardio-pulmonary Rehabilitation and Its Impact on Sleep Quality; a Prospective Analysis
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.
Read the detailed 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).
- Being tested
- Cardiopulmonary rehabilitation
- Medical subject headings
- Lung Diseases, Obstructive, Cardiomyopathies, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiopulmonary rehabilitationOther
Patients will undergo standardized cardio-pulmonary rehabilitation program.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Cardiopulmonary rehabilitation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks on average
Secondary outcomes (1)
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
Measured: 8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2020
- Study start11 May 2020
- Primary completion11 Oct 2024
- Study completion11 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- MetroHealth Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vidya Krishnan, MetroHealth Medical Center
- Investigators
- Vidya Krishnan, MD, Principal investigator, MetroHealth Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04668599
- Sponsor's protocol ID
- IRB19-00906
- Status last verified
- Nov 2024
- First submitted
- 7 Oct 2020
- Last updated
- 5 Nov 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No current plan to share individual participant data at this time.
Publications
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.
PubMed 23514215Omachi 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.
PubMed 22429651Scharf 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.
PubMed 21311688Youngstedt 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.
PubMed 9178916McDonnell 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.
PubMed 25010602
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardio-pulmonary Rehabilitation and Its Impact on Sleep Quality; a Prospective Analysis
- ClinicalTrials.gov ID
- NCT04668599
- Acronym / sponsor ID
- IRB19-00906
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- MetroHealth Medical CenterUniversity, hospital or other
- Study start
- 11 May 2020 (actual)
- Primary completion
- 11 Oct 2024 (actual)
- Study completion
- 11 Oct 2024 (actual)
- First posted
- 16 Dec 2020 (actual)
- Results
- Posted 5 Nov 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient with chronic lung or cardiac diseases | – | Other: Cardiopulmonary rehabilitationThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (1 listed)
- Not meeting inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiopulmonary rehabilitationPatients will undergo standardized cardio-pulmonary rehabilitation program. | Other | Patient with chronic lung or cardiac diseases |
Primary outcome
Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index
Time frame: 8 weeks on average
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.
1 secondary outcome
Change in Insomnia Severity Index
Time frame: 8 weeks.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23514215Soler 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.
- Background: PubMed 22429651Omachi 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.
- Background: PubMed 21311688Scharf 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.
- Background: PubMed 9178916Youngstedt 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.
- Background: PubMed 25010602McDonnell 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.
- Individual participant dataSharing planned: No. No current plan to share individual participant data at this time.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vidya Krishnan, MD principal investigator
MetroHealth Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obstructive Pulmonary Disease and Cardiomyopathies, run by MetroHealth Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index (time frame: 8 weeks on average). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04668599, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2024.