Benefits of an Aerobic and Strength Rehabilitation Program With Post-SARS-CoV-2 Patients Moderate-severe
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- 6MWT
研究概览
简要总结
The SARS-CoV-2 is a pulmonary pathology which is caused by SARS-COV2 and the main signs and symptoms are fever, dyspnea, cough, fatigue, muscular pain and more. Even if SARS-CoV-2 is an acute respiratory pathology we know that can cause some chronic conditions in the general status health of the patients. Besides, it can have an important impact in the physique condition such as a detrimental of the aerobic capacity, lung capacity based on the severity of the patient.
On the other hand, World Health Organization (WHO) has a criteria to classify the severity of SARS-CoV-2;
Saturation de O2 <94%,
PaO2/FiO2: <300mm
Frecuencia respiratoria > 30p/m
abscess Lung > 50%
septic shock
Multiorganic failure
Based on the high survival but the important number of side effects of this pathology remaining the detrimental of the health and exercise condition. We justify our study based on an aerobic exercise program with a strength part to improve those conditions of the patients.
详细描述
The investigators develop an aerobic exercise program for two treatment groups which one of them has a strength program as a supplement to verify if the aerobic exercise plus strength improve more than aerobic exercise alone the condition of COVID patients.
The protocol is based on 8 weeks of program with a baseline measurements and a follow ups after the 8º weeks, at 2, 4 and six months after finish the treatment to compare the effectiveness of both treatment and between them.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
Main investigators will be masked based on a randomization program. Outcomes Assessors will be not aware of the enrollment of participants and the study design to guaranty blinding of themselves.
Participants will be randomized by a program and they will not be aware about which groups could be more beneficial to guarantee blinding.
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
- •Patients had been got covid in the last 2 years.
- •No fractures, or major injuries which could compromised the movements of the patient
- •No major pathologies which deteriorate the general health status
排除标准
- •Psychiatric (moderate to severe)
- •Acute infection
- •Fractures (moderate to severe)
- •Cognitive detrimental state
结局指标
主要结局
6MWT
时间窗: 6 minutes
The 6-minute walking test (6MWT) measured the cardiovascular endurance and the Functional Independence Measure assessed the global functional capacity
sf 36
时间窗: 36 minutes
The 36-Item Short Form Health Survey (SF-36) is a widely it. The measure meets high psychometric standards \[20, 21\]. The 36 items represent eight scales: Physical functioning, role-physical, bodily pain, general health, vitality, social functioning, role-emotional and mental health. These eight scales form two higher order constructs: physical health (the first four scales) and mental health (the latter four scales). These constructs are represented by two summary measures: Physical Component Summary (PCS) measure and Mental Component Summary (MCS) measure. Scoring was completed as per standard instructions, using norm-based scoring algorithms. Lower scores on the MCS refect "frequent psychological distress, substantial social and role disability due to emotional problems; health in general rated 'poor'". Lower scores on the PCS refect "Substantial limitations in self-care, physical, social, and role activities; severe bodily pain; frequent tiredness; health rated 'poor'"
Timed up and Go (TUG)
时间窗: 5-7 minutes
Functional mobility was assessed through the timed up-and-go (TUG) test, five times sit-to-stand (FTSTS) test, functional reach and balance confidence. The TUG test measures the time taken by a participant to stand from a sitting position, walk 3 m, return and sit back down and is a measure of mobility. The FTSTS measures the time taken by a participant to switch from sitting-to-standing five times in a row and is a test of functional strength. Functional reach measures the distance a participant can reach forward with his or her arm outstretched while standing and is a test of balance. For each test, participants completed a practice run before the actual measurement
次要结局
- Heart beat(45 min)
- BORG(10 seconds)
- SARC-F questionnaire(10 minutes)
- Ecography(2-3 minutes)
- Saturation(45 min)
研究者
David Fernández
Benefits of an aerobic and strength program with Post-SARS-CoV-2 patients moderate-severe
Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz