Reconditioning Exercise for COVID-19 Patients Experiencing Residual sYmptoms
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Performance Based Physical Function
研究概览
简要总结
Individuals who had COVID-19 and are thought to have recovered from the disease often experience long-term symptoms such as fatigue, extreme tiredness and shortness of breath, a condition referred to as Long COVID. Previous studies have shown that regular exercise is beneficial for individuals suffering similar symptoms as a result of other diseases such as Chronic Fatigue Syndrome. The goal of this study is determine if participation in a three-month structured exercise program will improve physical function in individuals suffering from Long COVID.
详细描述
In December of 2019, a previously unknown betacoronavirus was discovered in the airways of patients with pneumonia in Wuhan, China. The novel coronavirus disease (COVID-19) caused by the virus (severe acute respiratory syndrome coronavirus (SARS-CoV-2)) spread rapidly around the world. Common symptoms include cough, fever, dyspnea (i.e. shortness of breath), musculoskeletal aches and pains and fatigue. These symptoms, most notably fatigue and dyspnea, have been reported months after the onset of the disease and often long after patients are thought to have recovered from the disease. Between one and two thirds of patients with milder forms of the disease report symptoms up to two months after the onset of symptoms. This condition is now referred to as Long COVID or Post- Acute Sequelae of SARS-CoV-2 infection, and the characteristic symptoms of this condition are dyspnea and extreme fatigue. Additionally, pulmonary, musculoskeletal, neurological, cardiac, and psychological sequelae in these survivors can affect their physical function and ability to perform activities of daily living. While exercise rehabilitation in patients recovering from COVID-19 has been cautiously recommended, there is little known about the response to exercise in patients with Long COVID-19 nor the optimal methods or strategies for rehabilitating these patients. Understanding the responses to an exercise program is instrumental in designing safe and effective rehabilitation strategies for these patients. The objective of this study is to examine the effect of a 3-month exercise therapy program on physical function in individuals who have recovered from COVID-19 between the previous 2 to 6 months, yet still report symptoms of the disease. The study is a randomized, wait-list-control pilot study designed to gather preliminary data. Participants will be randomized into one of two groups: an immediate treatment group or a wait-list-control group. The immediate treatment group will begin the exercise therapy program following randomization and will participate in the exercise program for a duration of three months. The wait-list-control group will receive usual care for the first three months, after which they will be allowed the opportunity to participate in the exercise therapy program for three months. Outcome measures will me made prior to randomization and following either the three-month exercise program or three months of usual care.
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
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •55 years of age or older
- •Able to read and speak English
- •Proof of a positive nucleic acid amplification test for the determination of COVID-19
- •Two months post positive nucleic acid amplification test for the determination of COVID
- •Self-report of COVID-19 symptoms (symptoms include any of the following: reduced exercise capacity, fatigue, cough, shortness of breath, headache and/or joint pain)
- •Able to understand and willing to sign a written informed consent document
- •Willing and able to complete all study procedures including attending all exercise sessions
排除标准
- •Currently exercising more than 60 minutes per week at a moderate intensity or 30 minutes per week at a high intensity
- •Current use of supplemental oxygen
- •Active treatment for cancer
- •Severe congestive heart failure, pulmonary disease, stroke, peripheral vascular disease, coronary artery disease and/or valvular heart disease
- •Positive graded exercise test
- •Major psychiatric disease
- •Severe liver or hepatic disease
- •Uncontrolled hypertension or diabetes
- •Orthopedic impairment that prevents participation in an exercise program
- •Blindness
- •BMI > 40kg/m2
- •Living more than 35 miles from exercise facility
- •Plans to move within the next 6 months
结局指标
主要结局
Performance Based Physical Function
时间窗: Week 12
Six minute walk distance will be used to measure performance based physical function. Subjects will walk at their chosen pace for six minutes on a pre-determined course. Total distance walked will be recorded.
Self-reported Physical Function
时间窗: Week 12
The Physical Functioning scale of the Medical Outcomes 36 Item Short Form (SF-36) will be used to measure self-reported physical function. Patient responses are rated on a on a 3-point scale (1- yes, limited a lot; 2 - yes, limited a little; or 3- no, not limited at all) and will then be normalized with a mean of 50 and standard deviation of 10.
次要结局
- Physical Function(Baseline and Week 12)