NCT05118711招募中不适用
COVID-19 Severity, Long-term Consequences for Exercise Capacity and Link to Associated Mechanisms
Arno Schmidt-Trucksäss1 个研究点 分布在 1 个国家目标入组 128 人开始时间: 2023年1月3日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 128
- 试验地点
- 1
- 主要终点
- Cardiorespiratory fitness (as % of predicted V̇O2max)
研究概览
简要总结
The project is designed as a cross-sectional study and aims to examine long-term consequences of coronavirus disease 2019 (COVID-19) for selected bio-behavioural parameters while taking the disease course severity into account.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •tested positive for SARS-CoV-2 using antigen- or PCR tests within the last 18 months
- •previous hospitalisation due to COVID-19
- •fully vaccinated (only for controls)
排除标准
- •inability to follow the study procedures (e.g. due to language barriers, psychological disorders, dementia, etc.),
- •known pregnancy or lactating women,
- •presence of any contraindications for exercising until maximum exhaustion, including insufficient blood pressure control (systolic >170 mmHg, diastolic >100 mmHg), ongoing cancer treatment, unstable angina pectoris, uncontrolled bradyarrhythmia or tachyarrhythmia, severe uncorrected valvular heart disease, clinically relevant acute infection, any form of musculoskeletal injury,
- •participating in any interventional clinical trial within the last four weeks,
- •previous participation in the current study
- •history of symptomatic COVID-19 (only for controls)
结局指标
主要结局
Cardiorespiratory fitness (as % of predicted V̇O2max)
时间窗: 1.5 hours after inclusion in study
Measured during cardiopulmonary exercise testing on a cycle ergometer.
次要结局
- Handgrip strength (in N)(1 hour after inclusion in study)
- Macrovascular flow-mediated dilation at rest (in %)(0.5 hours after inclusion in study)
- Cerebral oxygenation at peak exercise (in %)(1.5 hours after inclusion in study)
- Forced expiratory volume in 1 s (as % of predicted)(1.5 hours after inclusion in study)
- Forced vital capacity (as % of predicted)(1.5 hours after inclusion in study)
- Diffusion capacity of the lungs (as % of predicted)(1.5 hours after inclusion in study)
- Microvascular flow-mediated dilation at rest (in %)(2 to 14 days after inclusion in study)
- Muscle oxygenation at peak exercise (in %)(1.5 hours after inclusion in study)
- Total lung capacity (as % of predicted)(1.5 hours after inclusion in study)
- Cardiac output at peak exercise (in mL)(1.5 hours after inclusion in study)
- Handgrip rate of force development (in N/s)(1 hour after inclusion in study)
- Fatigue Assessment Scale (FAS) score(2 to 14 days after inclusion in study)
- Health distance(Calculated during statistical analysis)
- Score of depression, anxiety, and stress questionnaire (DASS21)(2 to 14 days after inclusion in study)
研究者
Arno Schmidt-Trucksäss
Sponsor-Investigator and Head of Rehabilitative and Regenerative Sports Medicine, Department of Sport, Exercise and Health
University of Basel
研究点 (1)
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