Resistance Training Intervention on the Clinical Status in Patients With Post Discharge Symptoms After Covid-19: The "EXER-COVID Study"
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes in Cardiorespiratory fitness
研究概览
简要总结
COVID-19 survivors commonly exhibit a marked extra-respiratory complication affecting the cardiac (arrhythmias and myocardial injury), renal (acute kidney injury), gastrointestinal, nervous (neuropathy, encephalopathy), endocrine and musculoskeletal (weakness, pain, and fatigue) systems. In this context, several studies have found that resistance training intervention promotes important health-related benefits, including cardiac function, compared to aerobic exercise training. Other exercise adaptations include increased skeletal muscle metabolism function, yet physio/psychological adaptations are known to be limited in COVID-19 survivors. Hence, given that resistance training intervention is implemented in a manner that is tolerable to the individual patient, it may be a potential beneficiary "personalized" rehabilitation treatment for patients with COVID-19 syndrome ambulatory.
The "EXER-COVID Clinical Study" project aims at determining the role of personalized exercise intervention in the treatment of post-COVID-19 syndrome ambulatory patients.
详细描述
100 patients will be recruited and undergo baseline testing, including examination, immune systems, biochemistry markers, ECG, DXA, metabolic/respiratory function, VO2max, muscular fitness, lipidomic/inflammatory/oxidative markers and psychological outcomes.
After baseline testing, participants will be randomly allocated into one group receiving standard of care (control group) or a group performing personalized resistance training intervention two times a week over a period of 6 weeks. The randomization procedure involves a computer-generated block randomization schedule in a ratio of 1:1 stratified by an independent person. Following the 8-week intervention period (with a 1-week washout period), both groups will complete a series of follow-up tests (as baseline testing). A 12-week follow-up experimental day is also planned in order to evaluate physio/psychological changes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Health Services Research
- 盲法
- Single (Investigator)
盲法说明
Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years
- •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-
- •Capable and willing to provide an informed consent.
排除标准
- •Pregnancy or breast-feeding.
- •Present atrial fibrillation.
- •Diagnosed with acute myocarditis.
- •Health conditions that prevent participating in the exercise intervention
- •Patients who cannot undergo VO2max (e.g. acute heart attack or unstable angina, aortic stenosis, acute endocarditis / pericarditis, uncontrolled high blood pressure, acute thromboembolism, severe heart failure, respiratory failure and uncontrolled acute decompensated diabetes mellitus or low blood sugar).
- •Treatment with IL-6 receptor antagonists (tocilizumab, kevzara) within the last month due to drug interference with the cardiopulmonary exercise adaptations.
结局指标
主要结局
Changes in Cardiorespiratory fitness
时间窗: Baseline, 6 Weeks and 12 Weeks
Measured with an incremental VO2 protocol on exercise bike by COSMED Quark CPET plus OMNIA (COSMED®, Rome, Italy)
次要结局
- Changes in thyroid function parameters(Baseline)
- Changes in cardio-ankle vascular index (CAVI)(Baseline, 6 Weeks and 12 Weeks)
- Changes in Energy expenditure(Baseline, 6 Weeks and 12 Weeks)
- Changes in bone mineral density measured with DXA(Baseline, 6 Weeks and 12 Weeks)
- Changes in total troponins levels (ng/mL)(Baseline)
- Changes in liver function(Baseline)
- Changes in renal function(Baseline)
- Changes in haematology parameters(Baseline)
- Changes in Axial accelerometer-based physical activity monitors(Baseline, 6 Weeks and 12 Weeks)
- Changes in blood samples analysed for markers related to oxidative stress(Baseline, 6 Weeks and 12 Weeks)
- Changes in serum metabolic profiles(Baseline, 6 Weeks and 12 Weeks)
- Changes in psychological stress(Baseline, 6 Weeks and 12 Weeks)
- Changes in physical health symptomology(Baseline, 6 Weeks and 12 Weeks)
- Changes in depressive symptomology(Baseline, 6 Weeks and 12 Weeks)
- Changes in Post-COVID manifestations(Baseline, 6 Weeks and 12 Weeks)
- Changes in Blood samples analysed for markers related to low grade inflammation(Baseline, 6 Weeks and 12 Weeks)
- Changes in creatinine kinase(Baseline)
- Changes in D-dimer(Baseline)
- Changes in cognitive status(Baseline, 6 Weeks and 12 Weeks)
- Changes in visual attention and task switching(Baseline, 6 Weeks and 12 Weeks)
- Changes in life satisfaction(Baseline, 6 Weeks and 12 Weeks)
- Changes in Fat max oxidation rate(Baseline, 6 Weeks and 12 Weeks)
- Changes in Dynamic and isometric strength(Baseline, 6 Weeks and 12 Weeks)
- Changes in pulse wave velocity(Baseline, 6 Weeks and 12 Weeks)
- Changes in fat mass measured with DXA(Baseline, 6 Weeks and 12 Weeks)
- Changes in lean mass measured with DXA(Baseline, 6 Weeks and 12 Weeks)
- Changes in Quality of life(Baseline, 6 Weeks and 12 Weeks)
- Changes in psychological distress(Baseline, 6 Weeks and 12 Weeks)
- Changes in resilience(Baseline, 6 Weeks and 12 Weeks)
- Change in pain score using numeric 0-10 rating scale(Baseline, 6 Weeks and 12 Weeks)
- Changes in physical activity levels(Baseline, 6 Weeks and 12 Weeks)
- Tracking the amount of exercise variety participants feel they engage in(Baseline, 6 Weeks and 12 Weeks)
- Including Changes in mononuclear cells of peripheral blood (sub-sample 40 participants)(Baseline, 6 Weeks and 12 Weeks)