Trial Outcomes & Findings for Cardio-pulmonary Rehabilitation and Sleep Quality (NCT NCT04668599)

Last Updated: 2024-11-05

Results Overview

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.

Recruitment status

COMPLETED

Target enrollment

106 participants

Primary outcome timeframe

8 weeks on average

Results posted on

2024-11-05

Participant Flow

Participant milestones

Participant milestones
Measure	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.
Baseline to Completion of Rehab STARTED	106
Baseline to Completion of Rehab COMPLETED	63
Baseline to Completion of Rehab NOT COMPLETED	43
Completion of Rehab to 3-Month Followup STARTED	63
Completion of Rehab to 3-Month Followup COMPLETED	63
Completion of Rehab to 3-Month Followup NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cardio-pulmonary Rehabilitation and Sleep Quality

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Patient With Chronic Lung or Cardiac Diseases n=106 Participants 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.
Age, Continuous	63 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	71 Participants n=5 Participants
Sex: Female, Male Male	35 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	13 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	93 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	35 Participants n=5 Participants
Race (NIH/OMB) White	71 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Body-Mass Index (BMI)	29.9 kg/m2 STANDARD_DEVIATION 7.2 • n=5 Participants
Epworth Sleepiness Scale	9 units on a scale n=5 Participants

PRIMARY outcome

Timeframe: 8 weeks on average

Population: those who completed PR (8 weeks)

Outcome measures

Outcome measures
Measure	Patients Who Completed Rehab (8 Weeks) n=63 Participants 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.	Patients Who Completed Rehab and 3-month Followup (5 Months) n=59 Participants 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
Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index	-3.6 units on a scale Standard Deviation 2.7	-1.6 units on a scale Standard Deviation 2.8

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	Patients Who Completed Rehab (8 Weeks) n=63 Participants 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.	Patients Who Completed Rehab and 3-month Followup (5 Months) n=58 Participants 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
Change in Insomnia Severity Index	-5 units on a scale Standard Deviation 2.6	-2.8 units on a scale Standard Deviation 3.8

Adverse Events

Patient With Chronic Lung or Cardiac Diseases

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Vidya Krishnan

The MetroHealth

Phone: 2167784527

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place