Outpatient and Home Pulmonary Rehabilitation Program for Post COVID-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
研究概览
简要总结
Coronavirus-2019 disease (COVID-19) is a highly infectious respiratory disease that causes respiratory, physical and psychological dysfunction in patients.
With the increased understanding of the severity of COVID-19 and clinical evidence in accordance with the opinions of first-line clinical experts involved in the treatment of this epidemic, the investigators believe that the participation of patients with sequelae of COVID-19 in a Pulmonary Rehabilitation Program would be of utmost importance.
According to recent scientific recommendations for patients with sequelae of COVID-19, respiratory rehabilitation would alleviate symptoms of dyspnea, anxiety and depression and, eventually, improve physical functions and quality of life.
Therefore, it is essential to anticipate early rehabilitation after the acute phase of ARDS, in order to limit the severity of the effects of the ICU and promote rapid functional recovery. Physiotherapy will play a role in providing exercise, mobilization and rehabilitation interventions for survivors of critical illnesses associated with COVID-19, in order to enable a functional social return.
详细描述
The investigatores propose a clinical, prospective and consecutive study composed of participants with pulmonary sequelae of COVID-19 and pulmonary diseases such as COPD, Asthma, Bronchitis, Emphysema, Bronchiectasis and pulmonary fibrosis. Initially, all patients will undergo a physical assessment, pulmonary function tests and nutritional assessment, in addition to applying the modified dyspnea scale of the MMRC (Modified Medical Research Council) and the 6-minute walk test (6MWT), according to the standards recommended by the American Thoracic Society (ATS).
The proposed Outpatient and Home Pulmonary Rehabilitation Program is based on the Guidelines recommended by the Brazilian Society of Pulmonology (SBPT) and by the Global Initiative for Chronic Obstructive Lung Disease (GOLD), with a minimum duration of 12 weeks, frequency of 3 weekly sessions, accompanied by health professionals in this field.
Patients who seek care at municipal and state health services in the city of Anápolis, (Goiás) will be recruited. Patients with clinically stabilized COVID - 19 sequelae will be considered eligible, and who agree to participate in the study, signing the Informed Consent .
The outpatient PRP consisted of a combination of aerobic and strengthening exercises, lasting 12 weeks, frequency 3 times a week. Each session will consist of active warm-up exercises, upper and lower limb strengthening, aerobic conditioning and stretching exercises. The warm-up phase consists of intercalated calisthenic exercises for different muscle groups, according to each patient's tolerance.
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)
盲法说明
Only the outcome assessors will be blinded to the data due to the fact that we have a group of patients undergoing the Outpatient Rehabilitation Program and another group of patients undergoing the Home Rehabilitation Program with follow-up by Tele-Rehabilitation
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of pulmonary sequelae post COVID-19
- •Patients clinically stabilized
- •Who agreed to participate in the clinical study, signing the informed consent form, will be considered eligible.
排除标准
- •Hospitalized patients
- •Patients who present clinical instability
- •Patients who do not commit to adhering to the Pulmonary Rehabilitation Program
结局指标
主要结局
Exercise capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)
时间窗: 12 weeks
Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on exercise capacity assessed with the six minutes Walk Test ( 6MWT) in patients with pulmonary sequelae resulting from COVID-19.
Functional status after Pulmonary Rehabilitation Program (COVID-19REHAB)
时间窗: 12 weeks
Effects of an Ambulatory and Home Pulmonary Rehabilitation Program on levels of functional status assessed with the Medical Research Council (MRC) Scale in patients with pulmonary sequelae resulting from COVID-19.
次要结局
- Peripheral muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
- Levels of anxiety and depression after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
- Health costs after COVID - 19.(36 weeks)
- Quality of Life after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
- Inspiratory muscle strength after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
- Forced Vital Capacity after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
- Forced Expiratory Volume in first second after Pulmonary Rehabilitation Program (COVID-19REHAB)(12 weeks)
研究者
Luis Vicente Franco de Oliveira
Principal investigator
Centro Universitário de Anapolis