The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft

July 26, 2023 updated by: Hsien-Chum Wang, Shin Kong Wu Ho-Su Memorial Hospital

The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft: A Randomized Control Trial

This study aims to investigate the effects of cardiac rehabilitation on sleep quality and sleep duration in patients after coronary artery bypass graft.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Coronary artery disease (CAD) is one of the common cardiovascular diseases, including myocardial infarction and unstable angina pectoris. Using the Global Burden of Disease statistical data analysis in 2020, Khan and other scholars found that the global prevalence of CAD is about 1,655 per 100,000 people, and the prevalence rate in Taiwan is about 1759 per 100,000 people, slightly higher than the global prevalence rate. Therefore, all countries in the world attach great importance to the prevention and treatment of CAD. In addition to common risk factors such as age, metabolic disease, smoking, and poor lifestyle habits such as insufficient physical activity, the literature indicates that sleep quality and sleep duration are also significantly associated with CAD. A 2011 meta-analysis by Francesco et al. pointed out that people who sleep less than 5 hours have a higher risk of CAD and are significantly associated with higher mortality rate. Patients with CAD who self-reported poor sleep quality and short sleep duration still had a high proportion after heart-related treatment. In 1993, Redeker tracked the related symptoms of patients after coronary artery bypass graft(CABG) and found that the sleep disturbance of patients did not improve, but increased. A systematic review of the literature by Liao et al. also found similar results. The sleep quality and sleep duration of patients after CABG can be improved over time, but a high proportion of patients still complain of sleep disturbance. Therefore, the influence of sleep disturbance in patients with CAD will persist, and studies have also suggested that persistent sleep disturbance will increase the readmission rate and mortality rate of patients with CAD. Therefore, it is very important to actively manage the sleep quality and sleep time of patients with CAD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
40

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Taiwan
      • Taipei, Taiwan
        • Recruiting
        • Shin Kong Wu Ho-Su Memorial Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Age between 40-80 years old
  • Have undergone CABG
  • The score of PSQI > 5
  • Can accomplish with instructions and complete the evaluation process
  • Body mass index less than 35 Kg/m2

Exclusion Criteria:

  • Diagnosed with
  • Sleep apnea (e.g., obstructive sleep apnea, and central sleep apnea)
  • Drug or alcohol dependence
  • Psychology disease
  • Neurological or musculoskeletal disorders that may interfere with CR
  • Uncontrolled cardiac status (e.g., unstable angina, and uncontrolled arrhythmia)
  • Women in pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control group
Experimental: Cardiac rehabilitation group
Other: Cardiac rehabilitation
Using Cardiac rehabilitation for patients after coronary artery bypass graft

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Pittsburgh Sleep Quality Index (PSQI)
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
Range of 0-21, higher scores indicate worse sleep quality. Scores > 5 are taken to represent poor sleep quality
Change between baseline and 3 mons. after cardiac rehabilitation
Actigraphy
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
Objective sleep parameter. Wear on the non-dominant wrist for 24 hrs. Can measure the total sleep time (TST), sleep onset latency (SOL), wake after sleep onset (WASO), sleep efficiency (SE)
Change between baseline and 3 mons. after cardiac rehabilitation

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Epworth Sleepiness Scale (ESS)
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
General level of daytime sleepiness . 8 self-rated questions. The chance of dozing is rated on a scale of 0-3. Range of 0-24, higher scores indicate worse daytime sleepiness. Scores > 10 are taken to represent excessive daytime sleepiness.
Change between baseline and 3 mons. after cardiac rehabilitation
Visual analogue scale
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
Pain rating scales. Mark a 100 mm line to indicate pain intensity. 0 mm = no pain, 100 mm = worst pain
Change between baseline and 3 mons. after cardiac rehabilitation
Hospital Anxiety and Depression Scale (HADS)
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
Range of 0-21, higher scores indicate worse anxiety or depression. Scores > 10 are taken to represent anxiety or depression
Change between baseline and 3 mons. after cardiac rehabilitation
Cardiopulmonary exercise testing (CPET)
Time Frame: Change between baseline and 3 mons. after cardiac rehabilitation
Gold standard for exercise capacity. Protocol: Starting form 0 watt, increase 10-15 watt/min. Test termination: Reach ≥ 85% of maximal HR, Respiratory exchange ratio (RER) > 1.10, Participants feel exhausted
Change between baseline and 3 mons. after cardiac rehabilitation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Shin Kong Wu Ho-Su Memorial Hospital

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Hsien-Chum Wang, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
August 1, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 22, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 28, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 26, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20220504R

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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