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IRCT20200117046160N2 IRCT 2021-08-05 Mazandaran University of Medical Sciences "Effects of multimodal rehabilitation on recovery of ICU Acquired weakness following COVID-19" Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired weakness following coronavirus infection(COVID-19) 2020-03-20 anticipated 27 Complete https://irct.ir/trial/52484 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Supportive. N/A Condition 1: Novel Coronavirus(COVID-19). Condition 2: Intensive Care Unit Acquired Weakness. Intervention group: Patients return to the rehabilitation center three weeks after discharge from the hospital, and the rehabilitation program will be designed twice a week for two months (16 sessions in total) and the duration of each session will be approximately 40 minutes for each patient. Exercises for each session include: warm up and cool down, strength exercises for the upper and lower limbs, and Inspiratory muscle training (IMT) with the KH5 digital Power Breath (start with a resistance of 30% of maximal inspiratory pressure) . Aerobic exercise with a stationary bike and treadmill also starts according to the patient's ability and gradually increases its duration and intensity. Gradually increase the intensity of the exercises during the sessions ( in Aerobic , strength and breathing exercises) in proportion to the individual's progress. All sessions will be performed under supervision. Vital signs and oxygen saturation(SPO2) will be checked at the beginning of each session. After the rehabilitation sessions, the initial examinations (includes: peripheral and inspiratory muscle strength, 6-minute walk test, dyspnea scale, anxiety and depression scale, quality of life, body mass analysis)will be repeated.. Yes - There is a plan to make this available What will be shared: All recorded data will be reachable for clinical and academic researchers for one year after the article publications as non-identifiable files When: Accessibility to the data will be possible 6 months after the article publication for the applicants, for one year. To whom: Academic researchers and clinicians Conditions: It is allowed only with the permission of the head researcher, and with the condition of participating in the research. Where to obtain: Refer to the Email Address of the researchers: hanieadib@gmail.com atefehnajafi66102@gmail.com How to obtain: The request must be emailed to corresponding author. ID card and reason for the request must be sent . Once confirmed , the data will be emailed within a week. Comments:
public Hanie Adib
No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 hanieadib@gmail.com Mazandaran University of Medical Sciences scientific Hanie Adib
No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic
Sari Iran (Islamic Republic of) 4816868890 +98 11 3336 6552 hanieadib@gmail.com Mazandaran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Definitive diagnosis of Coronavirus based on Polymerase Chain Reaction (PCR) or lung CT Scan and expert opinion Intensive Care Unit Acquired Weakness (ICUAW) diagnosis based on the following criteria: - Total muscle strength points of 6 muscle groups bilaterally (Forearm flexion, wrist extension, Hip flexion, knee extension, Ankle dorsiflexion, Arm abduction) in manual examination according to Medical Research Council(MRC) criteria is less than 48 (out of 60 total points) - Normal consciousness based on Glasgow Coma Scale(GCS) (score 15 out of 15) - Opinion of an Anesthesiologist or Intensive Care Fellowship - History of hospitalization in ICU for more than 48 hours (with and without the need for Mechanical ventilation) no limit no limit Both Loss of consciousness Uncontrolled hypertension means: resting systolic blood pressure> 180 mmHg and / or resting diastolic blood pressure> 110 mmHg Chest pain Uncontrolled sinus tachycardia (> 120 beats / min) or Sinus bradycardia (HR <60) Concurrent heart disease such as: Decompensated heart failure and evidence of Ischemic heart disease, Symptomatic arrhythmia Hypoxia at rest (Oxygen saturation (SPO2)< 88%) Pulmonary artery hypertension (Pulmonary Artery Pressure(PAP) > 30mmHg) Fever or Acute systemic disease Uncontrolled Diabetes Mellitus( DM) Severe Orthopedic or Neurological problems that prevent exercise Other metabolic conditions such as: Acute thyroiditis, Hyperkalemia, Hypokalemia and Hypovolemia (Until adequate treatment) Severe Psychological disorders Poor compliance Problem transporting the patient to the Rehabilitation Center Absence of the patient from rehabilitation sessions (More than 2 sessions) U07.1 G72.81 Clinically-epidemiologically diagnosed COVID-19 Critical illness myopathy Rehabilitation Intervention group: Patients return to the rehabilitation center three weeks after discharge from the hospital, and the rehabilitation program will be designed twice a week for two months (16 sessions in total) and the duration of each session will be approximately 40 minutes for each patient. Exercises for each session include: warm up and cool down, strength exercises for the upper and lower limbs, and Inspiratory muscle training (IMT) with the KH5 digital Power Breath (start with a resistance of 30% of maximal inspiratory pressure) . Aerobic exercise with a stationary bike and treadmill also starts according to the patient's ability and gradually increases its duration and intensity. Gradually increase the intensity of the exercises during the sessions ( in Aerobic , strength and breathing exercises) in proportion to the individual's progress. All sessions will be performed under supervision. Vital signs and oxygen saturation(SPO2) will be checked at the beginning of each session. After the rehabilitation sessions, the initial examinations (includes: peripheral and inspiratory muscle strength, 6-minute walk test, dyspnea scale, anxiety and depression scale, quality of life, body mass analysis)will be repeated. Quality of life. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: World Health Organization Questionnaire. Peripheral muscle force. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Medical Research Council grading system. Inspiratory muscle strength. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Assessment of Maximal inspiratory pressure(MIP) with Power Breath KH5 device. Ability to perform activity of daily living(ADL). Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Katz Questionnaire. Assess the level of anxiety and depression. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Hospital Anxiety and Depression Scale(HADS) Questionnaire. Evaluation of muscle mass changes. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Bioelectrical impedance analysis device( BIA). The degree of dyspnea. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: Modified Medical Research Council( MMRC) Dyspnea scale. Evaluation of changes in Exercise capacity. Timepoint: Before the intervention and after the intervention (after 16th session). Method of measurement: 6 Minutes walk test. Mazandaran University of Medical Sciences Approved 2020-09-19 Ethics Committee of the Vice Chancellor for Research and Technology of Mazandaran University of Med Moallem Square, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences Sari Mazandaran Iran (Islamic Republic of)