Protocol summary
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Study aim
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Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired Weakness following COVID-19 infection
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Design
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Quasi-experimental clinical trial, without control group, without blinding and randomization, on 27 patients
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Settings and conduct
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All selected patients will be evaluated for 3 weeks after discharge by referring to the sports medicine clinic (located in Imam Khomeini Hospital in Sari). Rehabilitation will be designed as 2 sessions per week (16 sessions) and the duration of each session will be approximately 40 minutes for each patient. Exercises include: Strength exercises, Inspiratory Muscle Training with the KH5 digital Power Breath (Start with a resistance of 30% of Maximal Inspiratory Pressure) and Aerobic exercises using a Stationary Bike and Treadmill (Depending on the patient's Exercise capacity). Gradually increase the intensity of the exercises in proportion to the individual's progress. All sessions will be performed under supervision and the initial examinations will be repeated after the sessions.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Definitive diagnosis of Coronavirus based on Polymerase Chain Reaction Or lung CT Scan ; ICU Acquired Weakness diagnosis (Criteria: Total muscle strength, bilaterally according to Medical Research Council criteria is less than 48 (out of 60 total points) ; Normal consciousness ; History of hospitalization in ICU for more than 48 hours (with/without the need for Mechanical ventilation) Exclusion criteria: Loss of consciousness ; Concurrent Heart disease ; Hypoxia at rest ; Fever Or Acute systemic disease
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Intervention groups
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Patients with COVID-19 with a history of ICU admission, with Or without Mechanical ventilation, with ICU Acquired Weakness diagnosis
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Main outcome variables
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Peripheral muscle strength; Respiratory muscle strength; Quality of life
General information
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Reason for update
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Due to the mismatch between the predicted and realized dates for sample collection
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20200117046160N2
Registration date:
2021-08-05, 1400/05/14
Registration timing:
prospective
Last update:
2022-04-09, 1401/01/20
Update count:
1
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Registration date
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2021-08-05, 1400/05/14
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-03-20, 1399/01/01
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Expected recruitment end date
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2021-09-22, 1400/06/31
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Actual recruitment start date
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2021-08-06, 1400/05/15
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Actual recruitment end date
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2022-01-05, 1400/10/15
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Trial completion date
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2022-03-06, 1400/12/15
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Scientific title
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Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired weakness following coronavirus infection(COVID-19)
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Public title
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"Effects of multimodal rehabilitation on recovery of ICU Acquired weakness following COVID-19"
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Purpose
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Supportive
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Inclusion/Exclusion criteria
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Inclusion criteria:
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)
Exclusion criteria:
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)
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Age
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No age limit
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Gender
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Both
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Phase
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N/A
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Groups that have been masked
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No information
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Sample size
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Target sample size:
27
Actual sample size reached:
27
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Randomization (investigator's opinion)
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N/A
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Randomization description
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Blinding (investigator's opinion)
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Not blinded
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Blinding description
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Placebo
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Not used
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Assignment
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Single
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2020-09-19, 1399/06/29
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Ethics committee reference number
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IR.MAZUMS.REC.1400.148
Health conditions studied
1
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Description of health condition studied
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Novel Coronavirus(COVID-19)
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ICD-10 code
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U07.1
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ICD-10 code description
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Clinically-epidemiologically diagnosed COVID-19
2
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Description of health condition studied
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Intensive Care Unit Acquired Weakness
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ICD-10 code
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G72.81
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ICD-10 code description
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Critical illness myopathy
Primary outcomes
1
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Description
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Quality of life
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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World Health Organization Questionnaire
2
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Description
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Peripheral muscle force
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Medical Research Council grading system
Secondary outcomes
1
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Description
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Inspiratory muscle strength
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Assessment of Maximal inspiratory pressure(MIP) with Power Breath KH5 device
2
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Description
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Ability to perform activity of daily living(ADL)
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Katz Questionnaire
3
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Description
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Assess the level of anxiety and depression
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Hospital Anxiety and Depression Scale(HADS) Questionnaire
4
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Description
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Evaluation of muscle mass changes
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Bioelectrical impedance analysis device( BIA)
5
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Description
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The degree of dyspnea
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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Modified Medical Research Council( MMRC) Dyspnea scale
6
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Description
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Evaluation of changes in Exercise capacity
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Timepoint
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Before the intervention and after the intervention (after 16th session)
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Method of measurement
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6 Minutes walk test
Intervention groups
1
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Description
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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.
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Category
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Rehabilitation
1
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Sponsor
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Grant name
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1290004
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Grant code / Reference number
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۱۶۰۲۰۰۱۰۰۰
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Mazandaran University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Yes - There is a plan to make this available
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Study Protocol
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Yes - There is a plan to make this available
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Statistical Analysis Plan
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Yes - There is a plan to make this available
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Informed Consent Form
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Yes - There is a plan to make this available
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Clinical Study Report
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Yes - There is a plan to make this available
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Analytic Code
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Yes - There is a plan to make this available
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Data Dictionary
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Yes - There is a plan to make this available
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Title and more details about the data/document
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All recorded data will be reachable for clinical and academic researchers for one year after the article publications as non-identifiable files
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When the data will become available and for how long
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Accessibility to the data will be possible 6 months after the article publication for the applicants, for one year.
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To whom data/document is available
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Academic researchers and clinicians
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Under which criteria data/document could be used
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It is allowed only with the permission of the head researcher, and with the condition of participating in the research.
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From where data/document is obtainable
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Refer to the Email Address of the researchers:
hanieadib@gmail.com
atefehnajafi66102@gmail.com
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What processes are involved for a request to access data/document
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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.
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Comments
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