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临床试验/NCT05474339
NCT05474339招募中不适用

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

Shin Kong Wu Ho-Su Memorial Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2022年8月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
40
试验地点
1
主要终点
Pittsburgh Sleep Quality Index (PSQI)

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
40 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Pittsburgh Sleep Quality Index (PSQI)

时间窗: 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

Actigraphy

时间窗: 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)

次要结局

  • Epworth Sleepiness Scale (ESS)(Change between baseline and 3 mons. after cardiac rehabilitation)
  • Visual analogue scale(Change between baseline and 3 mons. after cardiac rehabilitation)
  • Cardiopulmonary exercise testing (CPET)(Change between baseline and 3 mons. after cardiac rehabilitation)
  • Hospital Anxiety and Depression Scale (HADS)(Change between baseline and 3 mons. after cardiac rehabilitation)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Hsien-Chum Wang

Physical therapy

Shin Kong Wu Ho-Su Memorial Hospital

研究点 (1)

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