Long COVID-19 Rehabilitation & Research Program
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 21
- 试验地点
- 2
- 主要终点
- Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.
研究概览
简要总结
The purpose of the study is to assess the physiologic, immunologic, and mental health effects of an exercise and pulmonary rehabilitation program on patients with Long COVID-19 (LC).
详细描述
1.0 Objectives 1.1 Describe the purpose, specific aims, or objectives.
The purpose is to assess the physiologic, immunologic, and mental health effects of a rehabilitation program on patients with Long COVID-19 (LHC).
1.2 State the hypotheses to be tested.
Long COVID-19 Patients who enroll and complete a 10 week program of Physiologic and Psychological Rehabilitation will have reduced Long COVID-19 Symptoms, Improved Physical Status, Reduced Inflammatory Markers, and Augmented Psychological Well Being.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Long COVID-19 Infection (Documented by PCR or patient report)
- •Age >= 18 years old.
- •At least 12 weeks since the initial COVID Infection.
- •One or more of the following symptom/signs: Fatigue, Dyspnea, Exercise Intolerance, Post Exertional Malaise and/or Difficulty Breathing.
- •Able to perform a cardiopulmonary exercise test.
排除标准
- •Patients is not able to perform technically acceptable pulmonary function tests and symptom-limited cardiopulmonary cycle ergometry tests.
- •Patients who desaturate to SpO2 <80% on screening incremental exercise testing.
- •Patients who have completed a pulmonary rehabilitation program in the six weeks prior to the screening visit or patients who are currently in a pulmonary rehabilitation program.
- •Patients who have taken an investigational drug within one month or six half-lives (whichever is greater) prior to screening visit (Visit 1).
- •Pregnant or nursing women.
- •Women of childbearing potential who are not using a highly effective method of birth control. Female patients will be considered of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.
- •Patients who are currently participating in another interventional study.
- •Malignancy for which the patient has undergone resection, radiation therapy, or chemotherapy within the last 2 years
- •Any other significant disease than COVID-19 which, in the opinion of the investigator, may i) put the patient at risk because of participation in the study, ii) influence the results of the study (e.g. Insulin or testosterone therapy, systemic corticosteroids, HIV, etc), iii) cause concern regarding the patient's ability to participate in the study.
结局指标
主要结局
Change in aerobic capacity (Peak Oxygen Uptake) at 10 weeks after rehabilitation comprehensive (normal intensity) pulmonary rehabilitation program.
时间窗: 10 weeks
Cardopulmonary - Exercise Outcomes.
次要结局
- Short Form (SF-36)(10 weeks)
- Fatigue Severity Scale (FSS)(10 weeks)
- General Anxiety Disorder Screener (GAD-7)(10 weeks)
- Pittsburg Sleep Quality Score (PSQI)(10 weeks)
- Modified Medical Research Council Dyspnea Scale (mMRC)(10 weeks)
- Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)(10 weeks)
- Patient Health Questionnaire (PHQ-9)(10 weeks)
- Short Form (SF-36)(10 weeks)
- Fatigue Severity Scale (FSS)(10 weeks)
- General Anxiety Disorder Screener (GAD-7)(10 weeks)
- Pittsburg Sleep Quality Score (PSQI)(10 weeks)
- Modified Medical Research Council Dyspnea Scale (mMRC)(10 weeks)
- Modified DePaul Assessment for Post-Exertional Malaise (DSQ-PEM)(10 weeks)
- Patient Health Questionnaire (PHQ-9)(10 weeks)
研究者
William Stringer, md
Principal Investigator
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center