Physical Rehabilitation in ICU in ARDS Patients With COVID-19
Physical Rehabilitation in Intensive Care Unit in Acute Respiratory Distress Syndrome Patients With COVID-19
The primary aim of this study is to evaluate the effect of physical rehabilitation performed in intensive care unit on the range of joint motions and muscle strength of survivors following discharge from intensive care unit in patients with COVID-19. Secondary outcome is to assess the duration of mechanical ventilation, length of stay in intensive care unit and in hospital, and mortality rates during intensive care unit stay and health related quality of life following discharge in survivors.
Until April 14 patients were provided all the intensive care managements except for rehabilitation and patients discharged before this time constituted the 'non-rehabilitation' group (n=17). Patients discharged after April 14 were provided rehabilitation in addition to usual intensive care unit care and constituted the study 'rehabilitation' group (n=18).
Passive range of motion exercises to each joint and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles were applied 6 days/week in the 'rehabilitation' group during intensive care unit stay.
調査の概要
詳細な説明
Patients with acute respiratory distress syndrome could develop muscle weakness associated with impairment of physical function defined as intensive care unit acquired weakness. Early rehabilitation is recommended to prevent complications including muscle weakness and joint contractures, enhance weaning from mechanical ventilation, improve outcome, quality of life.
COVID-19 is an acute infection with a high risk of enormous cytokine storm exacerbating the clinical condition in acute respiratory distress syndrome and is thought to further increase the risk of muscle weakness.
Study participants were recruited among patients hospitalized in the intensive care unit at Koc University Hospital. Standard care for these patients consisted of respiratory support, intravenous fluid therapy, medical treatment including anticoagulation and sedation, nutrition, change of position every 4 hours, and if needed, hemodynamic support. The non-rehabilitation group patients discharged before April 14, 2020, were provided with this standard care. The rehabilitation group patients that discharged after April 14, 2020, were provided rehabilitation in addition to usual standard care. The rehabilitation program consisted of a passive range of motion exercises for each joint of the extremities for 15 minutes/day, 6 days/week, and neuromuscular electrical stimulation to bilateral quadriceps and tibialis anterior muscles for 52 minutes/day, 6 days/week. The physiatrists evaluated the patients. Exercises and electrical stimulation were applied daily by physiotherapists. The physiatrist and anesthesiologist discussed the clinical status of the patients daily and the physiatrist modified the rehabilitation program, if needed. Patients were enrolled in the rehabilitation program if there is hemodynamical stability.
Information regarding demographic and clinical features, medications used, duration of mechanical ventilation, length of stay in the intensive care unit and hospital, and mortality were obtained from the digital patient records in both groups.
Following discharge, patients were evaluated for range of joint motion, manual muscle strength test, hand grip strength and Short form-36.
研究の種類
入学 (実際)
連絡先と場所
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
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Diagnosis of acute respiratory distress syndrome secondary to COVID-19
- Hospitalised in intensive care unit
- Age older than 18 years
Exclusion Criteria:
- Acute respiratory distress syndrome due to other pathogens or causes
- Younger than 18 years
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Non-rehabilitation
The patients hospitalised in ICU who were provided all the intensive care managements except for rehabilitation interventions (discharged from intensive care unit before April 14, 2020)
|
Rehabilitation
The patients hospitalised in ICU who were provided rehabilitation interventions in addition to all the intensive care managements.
(discharged from intensive care unit after April 14, 2020)
|
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 |
---|---|---|
Hand grip strength
時間枠:1 month after discharge from hospital
|
Hand grip strength is an indicator of overall muscle strength that predicts mortality in older patients.
Handgrip strength was measured using a handheld dynamometer according to the instructions of the American Society of Hand Therapists.Patients were seated placing their arms by their sides with the elbow flexed to 90°, the forearm mid-prone, and the wrist in neutral position.
Patients were asked to grip the dynamometer with maximal effort using standard verbal encouragement.
Three trials were performed in the dominant hand with a 30 sec rest between trials and the highest value was recorded in kg.
The cut-off values of grip strength is 28.6 kg in men and 16.4 kg in women.
The measurement was performed 1 month after discharge.
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1 month after discharge from hospital
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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 |
---|---|---|
Short form - 36
時間枠:1 month after discharge from hospital
|
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.
The measurement was performed 1 month after discharge.
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1 month after discharge from hospital
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Length of stay in intensive care unit
時間枠:through study completion, an average of 3 months
|
Number of days of stay in intensive care unit from admission to discharge
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through study completion, an average of 3 months
|
Length of stay in hospital
時間枠:through study completion, an average of 3 months
|
Number of days of stay in hospital from admission to hospital to discharge from hospital
|
through study completion, an average of 3 months
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Duration of invasive mechanical ventilation
時間枠:through study completion, an average of 3 months
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Number of days of invasive mechanical ventilation during intensive care unit
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through study completion, an average of 3 months
|
Manual muscle strength
時間枠:1 month after discharge from hospital
|
Manual muscle strength was graded via a composite of Medical Research Council Scale score which has an excellent inter-rater reliability in survivors of critical illness.
This scale range from 0 point (no muscle contraction) to 5 points (normal muscle strength).
Through examination of 3 muscle groups in each limb (arm abduction, forearm flexion, wrist extension, hip flexion, knee extension and ankle dorsiflexion), clinical important muscle weakness has been defined as a composite score < 48 out of maximum 60 points.
The measurement was performed 1 month after discharge.
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1 month after discharge from hospital
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Range of joint motion
時間枠:1 month after discharge from hospital
|
Range of joint motion was evaluated in upper and lower extremity joints by physical examination and the results were recorded as normal or restricted for each joint.
The measurement was performed 1 month after discharge.
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1 month after discharge from hospital
|
協力者と研究者
スポンサー
出版物と役立つリンク
一般刊行物
- Turan Z, Ozyemisci Taskiran O, Erden Z, Kokturk N, Kaymak Karatas G. Does hand grip strength decrease in chronic obstructive pulmonary disease exacerbation? A cross-sectional study. Turk J Med Sci. 2019 Jun 18;49(3):802-808. doi: 10.3906/sag-1811-22.
- Yoo JI, Choi H, Ha YC. Mean Hand Grip Strength and Cut-off Value for Sarcopenia in Korean Adults Using KNHANES VI. J Korean Med Sci. 2017 May;32(5):868-872. doi: 10.3346/jkms.2017.32.5.868.
- Dodoo-Schittko F, Brandstetter S, Blecha S, Thomann-Hackner K, Brandl M, Knuttel H, Bein T, Apfelbacher C. Determinants of Quality of Life and Return to Work Following Acute Respiratory Distress Syndrome. Dtsch Arztebl Int. 2017 Feb 17;114(7):103-109. doi: 10.3238/arztebl.2017.0103.
- Reid CL, Campbell IT, Little RA. Muscle wasting and energy balance in critical illness. Clin Nutr. 2004 Apr;23(2):273-80. doi: 10.1016/S0261-5614(03)00129-8.
- Clavet H, Hebert PC, Fergusson D, Doucette S, Trudel G. Joint contracture following prolonged stay in the intensive care unit. CMAJ. 2008 Mar 11;178(6):691-7. doi: 10.1503/cmaj.071056.
- Sosnowski K, Lin F, Mitchell ML, White H. Early rehabilitation in the intensive care unit: an integrative literature review. Aust Crit Care. 2015 Nov;28(4):216-25. doi: 10.1016/j.aucc.2015.05.002. Epub 2015 Jul 2.
- Connolly B, O'Neill B, Salisbury L, Blackwood B; Enhanced Recovery After Critical Illness Programme Group. Physical rehabilitation interventions for adult patients during critical illness: an overview of systematic reviews. Thorax. 2016 Oct;71(10):881-90. doi: 10.1136/thoraxjnl-2015-208273. Epub 2016 May 24.
- Walsh CJ, Batt J, Herridge MS, Dos Santos CC. Muscle wasting and early mobilization in acute respiratory distress syndrome. Clin Chest Med. 2014 Dec;35(4):811-26. doi: 10.1016/j.ccm.2014.08.016. Epub 2014 Sep 30.
- Akar O, Gunay E, Sarinc Ulasli S, Ulasli AM, Kacar E, Sariaydin M, Solak O, Celik S, Unlu M. Efficacy of neuromuscular electrical stimulation in patients with COPD followed in intensive care unit. Clin Respir J. 2017 Nov;11(6):743-750. doi: 10.1111/crj.12411. Epub 2015 Dec 16.
- Kleyweg RP, van der Meche FG, Schmitz PI. Interobserver agreement in the assessment of muscle strength and functional abilities in Guillain-Barre syndrome. Muscle Nerve. 1991 Nov;14(11):1103-9. doi: 10.1002/mus.880141111.
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- 2020.169.IRB1.037
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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