Clinical trial NCT05474339: The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft
Official title: The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Coronary Artery Disease
Coronary Artery Bypass Graft
Sleep Quality
Cardiac Rehabilitation
Keywords: Coronary Artery Disease
Coronary artery bypass graft
Sleep quality
Sleep duration
Cardiac rehabilitation
Lead sponsor: Shin Kong Wu Ho-Su Memorial Hospital
Sponsor class: OTHER
First posted: 2022-07-26
Enrollment: 40
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
measure: Actigraphy
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
Secondary outcomes:
measure: Epworth Sleepiness Scale (ESS)
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
measure: Visual analogue scale
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
measure: Cardiopulmonary exercise testing (CPET)
timeFrame: Change between baseline and 3 mons. after cardiac rehabilitation
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Shin Kong Wu Ho-Su Memorial Hospital
Study officials:
affiliation: Shin Kong Wu Ho-Su Memorial Hospital
name: Hsien-Chum Wang
role: PRINCIPAL_INVESTIGATOR
References: