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

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: Recruiting
• Conditions: Coronary Artery Disease; Cardiac Rehabilitation; Sleep Quality; Coronary Artery Bypass Graft
• Intervention / Treatment: Other: Cardiac rehabilitation

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: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hsien-chum Wang; Phone Number: 2540 +886-28332211; Email: whc2629278@gmail.com

Study Locations

• Taiwan
  • Taipei, Taiwan
    • Recruiting
    • Shin Kong Wu Ho-Su Memorial Hospital
    • Contact: Hsien-chum Wang; Phone Number: 2540 +886-28332211; Email: whc2629278@gmail.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Pittsburgh Sleep Quality Index (PSQI)	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	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

Outcome Measure	Measure Description	Time Frame
Epworth Sleepiness Scale (ESS)	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	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)	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)	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

• Sponsor: Shin Kong Wu Ho-Su Memorial Hospital
• Investigators: Principal Investigator: Hsien-Chum Wang, Shin Kong Wu Ho-Su Memorial Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2022
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): December 31, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 26, 2022

Study Record Updates

• Last Update Posted (Actual): July 28, 2023
• Last Update Submitted That Met QC Criteria: July 26, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: Coronary Artery Disease; Cardiac rehabilitation; Coronary artery bypass graft; Sleep quality; Sleep duration
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease
• Other Study ID 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