Cardiopulmonary Rehabilitation in Post-acute COVID-19 Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Changes in Cardiopulmonary exercise testing (CPET)
研究概览
简要总结
In 2022, though the optimized acute medical treatment of COVID-19 was determined, patients often experience the sequelae (also known as post-acute COVID-19 syndrome, the patients might develop cough, breathlessness, fatigue, weakness, impaired activities of daily livings etc.). Until now, there is no consensus for post-acute COVID-19 syndrome management. Previously, the cardiopulmonary rehabilitation revealed significant benefits in heart failure or chronic obstructive pulmonary disease. The aims of the study are demonstrating the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
详细描述
PURPOSE: To demonstrate the benefits and safety of cardiopulmonary rehabilitations in patients previously admitted to hospital because of COVID-19 with sequelae.
METHODS: The participants will be divided into two groups: one with cardiopulmonary rehabilitations programs under the supervision of therapists 3 times a week, 12 weeks in total with lifestyle modification (experimental group); and the other with lifestyle modification and health education (active-controlled group). Before and after the interventions, several endpoints in interested are performed by the physicians or the research assistants, including cardiopulmonary exercise training (CPET), 6-minute-walk-test (6MWT), pulmonary function tests (PFT), and quality of life (QoL, we plan to use SF-36) questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •be willing and able to provide written informed consent and comply with all procedures required by the protocol
- •be 20 - 80 years of age at the time of signing the Informed Consent Form
- •diagnosed with COVID-19 with PCR and admitted with at least moderate COVID-19 disease (with clinical symptoms or imaging evidence of low respiratory tract involvement)
- •diagnosed with COVID-19 for over 4 weeks but less than 2 years with fatigue, shortness of breath, cough, weakness, or impairments of activities of daily life
- •able to cooperate with the rehabilitation programs and cycling
排除标准
- •Patients under 20-year-old or over 80-year-old, pregnant, prisoners
- •Patients without national health insurance in Taiwan
- •The patient cannot follow instructions or cycling
结局指标
主要结局
Changes in Cardiopulmonary exercise testing (CPET)
时间窗: Baseline, Week 12
CPET is a non-invasive examination, which provides assessment of the integrative exercise responses involving the pulmonary, cardiovascular, hematopoietic, neuropsychological, and skeletal muscle systems. It permits the evaluation of both submaximal and peak exercise responses. CPET is currently act as a clinical applications for the evaluation of undiagnosed exercise intolerance and for the objective determination of functional capacity and impairment.
次要结局
- Changes in 36-Item Short Form Survey (SF-36)(Baseline, Week 12)
- Changes in Pulmonary function test (PFT)(Baseline, Week 12)
- Changes in 6 minutes walking test (6MWT)(Baseline, Week 12)
研究者
Hung-Chou Chen
Director and Attending Physician
Taipei Medical University Shuang Ho Hospital