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临床试验/NCT04668599
NCT04668599已完成不适用

Cardio-pulmonary Rehabilitation and Its Impact on Sleep Quality; a Prospective Analysis

MetroHealth Medical Center1 个研究点 分布在 1 个国家目标入组 106 人开始时间: 2020年5月11日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
106
试验地点
1
主要终点
Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index

研究概览

简要总结

In this prospective cohort study the investigators aim to evaluate the effect of pulmonary rehabilitation on sleep quality. Disturbed sleep is associated with, frequent exacerbations, increase in the severity of disease and increased mortality in chronic obstructive pulmonary disease (COPD). Sleep quality is a good predictor of quality of life in patients with stable COPD. However, there has been little investigation into non-pharmacological methods to improve sleep quality in patients with COPD and heart failure. It is also uncertain, how long the beneficial effects of cardio-pulmonary rehabilitation on sleep quality, if any, usually last. Due to lack of robust data, the investigators sought to find the effect of cardio-pulmonary rehabilitation on sleep quality.

详细描述

Sleep disorders including poor quality of sleep are common in patients with heart failure, chronic obstructive pulmonary disease (COPD) and, possibly, other chronic lung disorders. These patients complain of difficulty sleeping and sleep fragmentation, often related to symptoms such as cough, sputum production or shortness of breath. Patients with COPD and heart failure commonly have other abnormalities such as nocturnal oxygen desaturation that may further worsen sleep disturbances. Moreover, sleep disordered breathing (SDB), like obstructive sleep apnea syndrome (OSA), has been linked to higher morbidity and mortality if COPD is present (known as Overlap syndrome). In patients with COPD and heart failure, cardio-pulmonary rehabilitation has important health benefits such as improvement in disease related symptoms, exercise tolerance, and health-related quality of life. However, the effect of cardio-pulmonary rehabilitation on sleep quality is controversial. Disturbed sleep is associated with frequent exacerbations, increase in the severity of disease and increased mortality in COPD and heart failure patients.

The investigators hypothesize that cardio-pulmonary rehabilitation results in improved sleep quality in patients with chronic lung disease and heart failure, this may be an important contributor to improved health outcomes after completion of cardio-pulmonary rehabilitation program.

The study will use data from questionnaires filled by the patients before and after completion of cardio-pulmonary rehabilitation. A 3-month follow up survey using the same questionnaires will be conducted to determine the longevity of improved sleep quality (if present). The questionnaires that will be used include Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS), Berlin questionnaire, COPD assessment test (CAT) for COPD patients, Kansas city cardiomyopathy questionnaire (KCCQ) for heart failure patients, hospital induced anxiety and depression scale (HADS) and insomnia severity index (ISI).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age > 18 years
  • Patient who are willing to participate in follow-up survey 3 months after completion of pulmonary rehabilitation.
  • Patients who complete rehabilitation for at least 8 weeks.

排除标准

  • Not meeting inclusion criteria

结局指标

主要结局

Improvement in Sleep Quality Using Pittsburgh Sleep Quality Index

时间窗: 8 weeks on average

Pittsburgh sleep quality index is validated questionnaire and will be used to determine improvement in sleep quality before and after completion of cardiopulmonary rehabilitation. Pittsburgh sleep quality index comprises of seven components. Each component is marked from 0 to 3, with a maximum total score of 21 and a minimum total score of 0. A score of less than 5 indicates good overall sleep quality and a score of 5 and more indicates poor sleep quality. From literature review using Pittsburgh sleep quality index, minimal clinically important difference was determined to be 3 between before and after measurements.

次要结局

  • Change in Insomnia Severity Index(8 weeks.)

研究者

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

Vidya Krishnan

Professor, Case Western Reserve University.

MetroHealth Medical Center

研究点 (1)

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