Cardiomyopathies, Heart Failure, Obstructive Pulmonary Disease, Restrictive Lung Disease
Conditions
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.
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).
Interventions
Patients will undergo standardized cardio-pulmonary rehabilitation program.
Sponsors
MetroHealth Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Insomnia Severity Index | 8 weeks. | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 106 |
| Total | 106 |
Baseline characteristics
| Characteristic | Patient With Chronic Lung or Cardiac Diseases |
|---|---|
| Age, Continuous | 63 years STANDARD_DEVIATION 7.9 |
| Body-Mass Index (BMI) | 29.9 kg/m2 STANDARD_DEVIATION 7.2 |
| Epworth Sleepiness Scale | 9 units on a scale |
| Ethnicity (NIH/OMB) Hispanic or Latino | 13 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 93 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 35 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 71 Participants |
| Sex: Female, Male Female | 71 Participants |
| Sex: Female, Male Male | 35 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 106 |
| other Total, other adverse events | 0 / 106 |
| serious Total, serious adverse events | 0 / 106 |
Outcome results
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.
Time frame: 8 weeks on average
Population: those who completed PR (8 weeks)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Completed Rehab (8 Weeks) | Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index | -3.6 units on a scale | Standard Deviation 2.7 |
| Patients Who Completed Rehab and 3-month Followup (5 Months) | Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index | -1.6 units on a scale | Standard Deviation 2.8 |
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
Time frame: 8 weeks.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Patients Who Completed Rehab (8 Weeks) | Change in Insomnia Severity Index | -5 units on a scale | Standard Deviation 2.6 |
| Patients Who Completed Rehab and 3-month Followup (5 Months) | Change in Insomnia Severity Index | -2.8 units on a scale | Standard Deviation 3.8 |