Functional Capacity in Survivors of COVID-19 Related ARDS
2021年7月3日 更新者：Koç University
Functional Capacity in Survivors of COVID-19 Related ARDS: A Cross-sectional Study
Acute respiratory distress syndrome survivors frequently develop impaired physical function, muscle weakness and quality of life.
The aim of this retrospective study is to determine the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools.
COVID-19 related acute respiratory distress syndrome survivors were assessed 4 weeks following discharge from the hospital, 15 patients who attended the evaluation will be included the study.
All subjects underwent standardized physical clinical evaluation, Medical Research Council-sumscore, hand-grip strength, 6-minute walk test, chair-stand test, timed up and go test and Short form-36, 4 weeks after hospital discharge.
研究概览
详细说明
COVID-19 could cause acute respiratory distress syndrome in a minority of patients.
After recovery from acute critical illness and discharged from hospital, secondary disabilities related to Post Intensive Care Syndrome could take over the role.
There is limited data and information about the functional capacity of these patients after hospital discharge.Follow-up these patients after discharge might help assessing the symptoms of Post Intensive Care Syndrome, functional capacity and need of physical therapy, therefore give care for the impairments.
The aim of this retrospective cross-sectional study is to demonstrate the functional capacity, global muscle weakness and quality of life of COVID-19 survivors after 4 weeks following hospital discharge and the relationship between different tools.
Appointment was given all of the ARDS survivors related to COVID-19 who treated in ICU after 4 weeks following discharge from hospital in order to assess the need of rehabilitation.
15 patients who attended the evaluation will be included the study.
研究类型
观察性的
注册 (预期的)
15
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Ihsan Solaroglu, Prof
- 电话号码：+ 90 212 338 10 39
- 邮箱：isolaroglu@ku.edu.tr
研究联系人备份
- 姓名：Baris Ata, Prof
- 电话号码：+ 90 212 338 10 39
- 邮箱：bata@ku.edu.tr
学习地点
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Istanbul、火鸡、34010
- Koc University School of Medicine
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Acute respiratory distress syndrome survivors related to COVID-19
描述
Inclusion Criteria:
- to be older that 18 years
- Acute respiratory distress syndrome survivors related to COVID-19 who treated in Intensive care unit and attend appointment after 4 weeks following discharge from hospital
Exclusion Criteria:
- History of diseases that could affect functional capacity, muscle strength and quality of life, such as cancer, spinal cord disease, neuromuscular diseases
- do not want to attend the study
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Six-minute walk test
大体时间：1 day
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Six-minute walk test is a field test evaluating submaximal aerobic capacity.
The technical standards are defined by European Respiratory Society and American Thoracic Society.
The individuals were asked to walk as far as possible in a 30-meter corridor in 6 minutes and the distance, oxygen saturation, heart rate, systolic blood pressure and dyspnea scale (Borg 0-20) were recorded before and immediately after the test, and recovery period (1.
minute of recovery).
It is a valid and responsive measurement of functional capacity and also predicts quality of life in Acute respiratory distress syndrome survivors
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1 day
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Handgrip strength
大体时间：1 day
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Handgrip strength will be measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.
Patients will be requested to seat placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position.
Using standard verbal encouragement, patients will be asked to grip the dynamometer with dominant hand with maximal effort.
Three trials will be performed with a 30-second interval between trials and the highest value will be recorded in kg.
The cut-off values of grip strength are 28.6 kg in men and 16.4 kg in women.
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1 day
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Medical Research Council-sumscore
大体时间：1 day
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It is valid and reliable tool in survivors of critical illness, it will be used in order to evaluate the overall muscle strength
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1 day
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Short form - 36
大体时间：1 day
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Short form - 36 measures health related quality of life.
It is a self-reported survey that evaluates individual health status with eight parameters consisting of physical function, pain, role limitations attributed to physical problems, role limitations attributed to emotional problems, mental health, social functioning, energy/ vitality, general health perception.
There is not a summary score, each section is scored between 0-100, 0 indicates the worst condition, 100 indicates the best.
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1 day
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Chair stand test
大体时间：1 day
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It is used to evaluate strength and endurance of lower limbs.
Patients will be asked to sit on a chair with a 46 cm seat height by crossing their hands over their chest and stand and sit five times consecutively as fast as possible.
The test starts in the sitting position and terminate at the last sitting position and the time will be recorded.
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1 day
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timed up and go test
大体时间：1 day
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The test will be used to assess physical function.
It is an objective, reliable and simple test to evaluate both balance and functional movement.
The patients will be asked to get up from a chair, walk 3 m, turn around, walk back and sit on the chair again.
The time will be recorded in seconds.
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1 day
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Wu Z, McGoogan JM. Characteristics of and Important Lessons From the Coronavirus Disease 2019 (COVID-19) Outbreak in China: Summary of a Report of 72 314 Cases From the Chinese Center for Disease Control and Prevention. JAMA. 2020 Apr 7;323(13):1239-1242. doi: 10.1001/jama.2020.2648. No abstract available.
- Chan KS, Zheng JP, Mok YW, Li YM, Liu YN, Chu CM, Ip MS. SARS: prognosis, outcome and sequelae. Respirology. 2003 Nov;8 Suppl(Suppl 1):S36-40. doi: 10.1046/j.1440-1843.2003.00522.x.
- Ngai JC, Ko FW, Ng SS, To KW, Tong M, Hui DS. The long-term impact of severe acute respiratory syndrome on pulmonary function, exercise capacity and health status. Respirology. 2010 Apr;15(3):543-50. doi: 10.1111/j.1440-1843.2010.01720.x. Epub 2010 Mar 19.
- Hui DS, Wong KT, Ko FW, Tam LS, Chan DP, Woo J, Sung JJ. The 1-year impact of severe acute respiratory syndrome on pulmonary function, exercise capacity, and quality of life in a cohort of survivors. Chest. 2005 Oct;128(4):2247-61. doi: 10.1378/chest.128.4.2247.
- Held N, Moss M. Optimizing Post-Intensive Care Unit Rehabilitation. Turk Thorac J. 2019 Apr 1;20(2):147-152. doi: 10.5152/TurkThoracJ.2018.18172. Print 2019 Apr.
- Turan Z, Topaloglu M, Ozyemisci Taskiran O. Medical Research Council-sumscore: a tool for evaluating muscle weakness in patients with post-intensive care syndrome. Crit Care. 2020 Sep 18;24(1):562. doi: 10.1186/s13054-020-03282-x. No abstract available.
- Wilcox ME, Herridge MS. Lung function and quality of life in survivors of the acute respiratory distress syndrome (ARDS). Presse Med. 2011 Dec;40(12 Pt 2):e595-603. doi: 10.1016/j.lpm.2011.04.024. Epub 2011 Nov 9.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (预期的)
2021年7月1日
初级完成 (预期的)
2021年8月1日
研究完成 (预期的)
2021年9月1日
研究注册日期
首次提交
2021年7月3日
首先提交符合 QC 标准的
2021年7月3日
首次发布 (实际的)
2021年7月7日
研究记录更新
最后更新发布 (实际的)
2021年7月7日
上次提交的符合 QC 标准的更新
2021年7月3日
最后验证
2021年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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