The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft
Primary Purpose
Coronary Artery Disease, Coronary Artery Bypass Graft, Sleep Quality
Status
Recruiting
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Cardiac rehabilitation
Sponsored by
About this trial
This is an interventional treatment trial for Coronary Artery Disease focused on measuring Coronary Artery Disease, Coronary artery bypass graft, Sleep quality, Sleep duration, Cardiac rehabilitation
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
Sites / Locations
- Shin Kong Wu Ho-Su Memorial HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Cardiac rehabilitation group
Control group
Arm Description
Outcomes
Primary Outcome Measures
Pittsburgh Sleep Quality Index (PSQI)
Range of 0-21, higher scores indicate worse sleep quality. Scores > 5 are taken to represent poor sleep quality
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)
Secondary Outcome Measures
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.
Visual analogue scale
Pain rating scales. Mark a 100 mm line to indicate pain intensity. 0 mm = no pain, 100 mm = worst pain
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
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
Full Information
NCT ID
NCT05474339
First Posted
July 22, 2022
Last Updated
July 26, 2023
Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05474339
Brief Title
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
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 1, 2022 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shin Kong Wu Ho-Su Memorial Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Cardiac rehabilitation group
Arm Type
Experimental
Arm Title
Control group
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Cardiac rehabilitation
Intervention Description
Using Cardiac rehabilitation for patients after coronary artery bypass graft
Primary Outcome Measure Information:
Title
Pittsburgh Sleep Quality Index (PSQI)
Description
Range of 0-21, higher scores indicate worse sleep quality. Scores > 5 are taken to represent poor sleep quality
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
Title
Actigraphy
Description
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)
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
Secondary Outcome Measure Information:
Title
Epworth Sleepiness Scale (ESS)
Description
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.
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
Title
Visual analogue scale
Description
Pain rating scales. Mark a 100 mm line to indicate pain intensity. 0 mm = no pain, 100 mm = worst pain
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
Title
Hospital Anxiety and Depression Scale (HADS)
Description
Range of 0-21, higher scores indicate worse anxiety or depression. Scores > 10 are taken to represent anxiety or depression
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
Title
Cardiopulmonary exercise testing (CPET)
Description
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
Time Frame
Change between baseline and 3 mons. after cardiac rehabilitation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hsien-chum Wang
Phone
+886-28332211
Ext
2540
Email
whc2629278@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hsien-Chum Wang
Organizational Affiliation
Shin Kong Wu Ho-Su Memorial Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Shin Kong Wu Ho-Su Memorial Hospital
City
Taipei
Country
Taiwan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hsien-chum Wang
Phone
+886-28332211
Ext
2540
Email
whc2629278@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
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The Effects of Cardiac Rehabilitation on Sleep Quality and Sleep Duration in Patients After Coronary Artery Bypass Graft
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