Impact of Pulmonary Rehabilitation on Quality of Life, Body Composition and Respiratory Function of Patients With a History of COVID-19
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Change in the quality of life
研究概览
简要总结
This study will determine the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.
详细描述
In December 2019, a novel coronavirus, SARS-CoV-2, appeared, causing a wide range of symptoms, mainly respiratory infection. In March 2020, the World Health Organization (WHO) declared Coronavirus Disease 2019 (COVID-19) a pandemic. COVID-19 has spread rapidly over several months, affecting patients across all age groups and geographic areas. The disease has a diverse course; patients may range from asymptomatic to those with respiratory failure, complicated by acute respiratory distress syndrome.
The main objective of this study is to assess the impact of pulmonary rehabilitation on quality of life, body composition and respiratory function in patients with a history of COVID-19.
The patients after COVID-19 will be included in the pulmonary rehabilitation protocol. The duration of rehabilitation will depend on the patient's condition: from 7 to 14 days.
Measurements:
- quality of life (WHOQoL-BREF)
- body composition (bioelectrical impedance analysis, BC-420 MA, Tanita)
- weight, height and BMI
- spirometry (Spirometr PNEUMO, abcMED)
- diffusion lung capacity for carbon monoxide (LUNGTEST 1000)
- morphology (CRP, D-Dimer, WBC) and gasometry (pCO2, pO2)
- chest computed tomography (CT).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female patients treated in Provincial Clinical Hospital No. 1 in Rzeszów/ Podkarpackie Center for Lung Diseases in Rzeszów,
- •Patients with a history of COVID-19,
- •Having obtained written informed consent (signed and dated) to participate in the study,
- •Age at enrollment ≥ 18 years of age,
- •No contraindications to pulmonary rehabilitation,
- •No contraindications for body composition testing (bioelectrical impedance analysis).
排除标准
- •Refusal to participate in the study,
- •Patients with any acute disease in the last 3 months before baseline,
- •Patients currently enrolled in any clinical trial,
- •Currently infected patients with COVID-19.
结局指标
主要结局
Change in the quality of life
时间窗: at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion
Comparison of the World Health Organization Quality of Life (WHOQOL-BREF) questionnaire mean between baseline, immediately after the end of the rehabilitation protocol, and 3 months after the end of the rehabilitation protocol. The questionnaire consists of 26 questions. Answers are awarded a score in a five-point scale (1-5). Answer scores are calculated according to the WHOQOL-BREF algorithm in the range of 0-100 points. Higher score corresponds to higher quality of life.
次要结局
- Change in respiratory flow parameters (spirometry)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in gasometry (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in lung diffusing capacity(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in Body Mass Index (BMI)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in the body composition (bioelectrical impedance analysis)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in C-reactive protein (CRP) values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in white blood cell (WBC) values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in lung volume parameters (spirometry)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in D-Dimer values (blood sample)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
- Change in the percentage of opacity (chest computed tomography)(at baseline, immediately after rehabilitation completion, and 3 months after rehabilitation completion)
研究者
Justyna Wyszyńska
Principal Investigator
University of Rzeszow