Rehabilitation for Post-COVID-19 Syndrome Through a Multicomponent, Educational and Supervised Exercise Intervention [RECOVE]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 83
- 试验地点
- 2
- 主要终点
- Changes in subject clinical status
研究概览
简要总结
This is a randomized controlled trial of the efficacy of a tailored exercise program, based on multicomponent exercise training and/or inspiratory muscle training, compared to the WHO self-management leaflet commonly used in outpatient scenarios, on the recovery of persistent symptoms and functional limitations after COVID-19.
. The primary objective of the study is to evaluate the clinical efficacy and safety of a tailored exercise-based treatment relative to the control arm in improving the subject clinical status in ambulatory patients.
详细描述
A fraction ~10% of the COVID-19 patients who undergo a variable acute symptomatic phase of the disease are coming forward with continuing effects of the disease over a month, with chronic complaints like mental fog, delayed latent periods in recalling events of recent past, tachycardia, extreme fatigue, inability to perform daily physical tasks and likely to develop stress, depression, irritability, insomnia, fear, confusion, anger and frustration. This condition is defined as post-COVID-19 syndrome and increasingly affecting a high number of people as the pandemic evolves.
The post-COVID-19 syndrome has become a usual situation in the evolutionary course of the disease with its own entity. The National Health Service (NHS) of UK has recently published a clinical guide for long-term management of the effects of COVID-19 with a comprehensive plan for the assessment and care of patients who present or develop symptoms from the fourth week after diagnosis.
The effective long-term management of the effects of COVID-19 is a challenge that requires awareness. The RECOVE project aims at determining the role of exercise in the treatment of post-COVID-19 syndrome ambulatory patients.
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
- Single (Outcomes Assessor)
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
- •SARS-CoV-2 diagnosed using real-time reverse transcriptase polymerase chain reaction (PCR) tests or positive for SARS-CoV-2 virus antigen >90 days before randomization.
- •Still present a chronic symptomatic phase lasting >90 days since debut of symptoms
- •Have not been hospitalized
- •There is no evidence on clinical records of pneumonia or any other organ failure related to SARS-CoV-2
- •Non-coincident participation in any intervention trial
- •Capable and willing to provide an informed consent
排除标准
- •Refusal to participate expressed by patient or legally authorized representative if they are present
- •Pregnancy or breast-feeding.
- •Acute heart attack (recent 3-6 months) or unstable angina
- •Uncontrolled atrial or ventricular arrhythmias
- •Aortic dissecting aneurysm
- •Severe aortic stenosis
- •Acute endocarditis / pericarditis
- •Uncontrolled high blood pressure (>180/100 mmHg)
- •Acute thromboembolism
- •Acute or severe heart failure
- •Acute or severe respiratory failure
- •Uncontrolled acute decompensated diabetes mellitus or low blood sugar
- •A recent fracture in the last month.
- •Conditions preventing cooperation
结局指标
主要结局
Changes in subject clinical status
时间窗: Baseline to 8 Weeks
Post-COVID Functional Status (PCFS) on a 5-point ordinal scale (0 to 4 grades) and medical screening
次要结局
- Changes in high sensitivity C-reactive protein (hsCPR)(Baseline to 8 Weeks)
- Changes in serum creatine kinase (CK)(Baseline to 8 Weeks)
- Changes in tolerance to exercise: DePaul Symptom Questionnaire for Post-exertional malaise (DSQ-PEM) scores(Baseline to 8 Weeks)
- Changes in pulmonary function: Forced expiratory volume (FEV)(Baseline to 8 Weeks)
- Changes in lactate dehydrogenase (LDH)(Baseline to 8 Weeks)
- Changes in anxiety: Generalized Anxiety Disorder scale (GAD7)(Baseline to 8 Weeks)
- Changes in neuromuscular performance during resistance exercise: Barbell Mean Propulsive Velocity (MPV)(Baseline to 8 Weeks)
- Changes in D-dimer(Baseline to 8 Weeks)
- Changes in depression: Patient Health Questionnaire (PHQ9)(Baseline to 8 Weeks)
- Changes in balance: center of pressure (COP) sway(Baseline to 8 Weeks)
- Changes in health related quality of life: 12-item Short Form Survey (SF12)(Baseline to 8 Weeks)
- Changes in cardiovascular fitness: Maximal oxygen consumption (VO2max)(Baseline to 8 Weeks)
- Changes in pulmonary function: Forced Vital Capacity (FVC)(Baseline to 8 Weeks)
- Changes in Troponin(Baseline to 8 Weeks)
- Changes in glutamic-pyruvic transaminase (GPT)(Baseline to 8 Weeks)
- Changes in physical activity levels(Baseline to 8 Weeks)
- Changes in fatigue: Chalder Fatigue Scale scale (CFQ-11)(Baseline to 8 Weeks)
研究者
Javier Courel Ibáñez
Principal Investigator
Universidad de Murcia