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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (予想される)
15
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Ihsan Solaroglu, Prof
- 電話番号：+ 90 212 338 10 39
- メール：isolaroglu@ku.edu.tr
研究連絡先のバックアップ
- 名前：Baris Ata, Prof
- 電話番号：+ 90 212 338 10 39
- メール：bata@ku.edu.tr
研究場所
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Istanbul、七面鳥、34010
- Koc University School of Medicine
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年歳以上 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
Acute respiratory distress syndrome survivors related to COVID-19
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Six-minute walk test
時間枠：1 day
|
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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Handgrip strength
時間枠：1 day
|
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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
- 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.
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (予想される)
2021年7月1日
一次修了 (予想される)
2021年8月1日
研究の完了 (予想される)
2021年9月1日
試験登録日
最初に提出
2021年7月3日
QC基準を満たした最初の提出物
2021年7月3日
最初の投稿 (実際)
2021年7月7日
学習記録の更新
投稿された最後の更新 (実際)
2021年7月7日
QC基準を満たした最後の更新が送信されました
2021年7月3日
最終確認日
2021年7月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 2021.014.IRB1.008
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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