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Protocol summary
Quasi-experimental clinical trial, without control group, without blinding and randomization, on 15 patients
Quasi-experimental clinical trial, without control group, without blinding and randomization, on 27 patients
Quasi-experimental clinical trial, without control group, without blinding and randomization, on 1527 patients
کارآزمایی بالینی نیمه تجربی ،بدون گروه کنترل، بدون کورسازی و تصادفی سازی ، روی 15 بیمار
کارآزمایی بالینی نیمه تجربی ،بدون گروه کنترل، بدون کورسازی و تصادفی سازی ، روی 27 بیمار
کارآزمایی بالینی نیمه تجربی ،بدون گروه کنترل، بدون کورسازی و تصادفی سازی ، روی 1527 بیمار
General information
15
27
1527
empty
27
27
empty
2021-08-06, 1400/05/15
2021-08-06 00:00:00
empty
2022-01-05, 1400/10/15
2022-01-05 00:00:00
empty
2022-03-06, 1400/12/15
2022-03-06 00:00:00
empty
Due to the mismatch between the predicted and realized dates for sample collection
Due to the mismatch between the predicted and realized dates for sample collection
empty
به دلیل عدم تطابق تاریخ پیش بینی شده و تحقق یافته جهت جمع آوری نمونه
به دلیل عدم تطابق تاریخ پیش بینی شده و تحقق یافته جهت جمع آوری نمونه
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)
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)
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(Forearmbilaterally (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)
تشخیص قطعی کروناویروس بر اساس تست واکنش زنجیره ای پلیمراز یا سی تی اسکن ریه و نظر متخصص مربوطه
تشخیص ضعف اکتسابی ناشی از بستری در بخش مراقبت های ویژه بر اساس معیارهای زیر: -مجموع امتیاز قدرت عضلانی 6گروه عضلانی به صورت دو طرفه( فلکسیون ساعد، اکستانسیون مچ دست، فلکسیون ران، اکستانسیون زانو، درسال فلکسیون مچ پا، ابداکسیون بازو) در معاینه ی دستی بر طبق معیار انجمن تحقیقات پزشکی کمتر از 48 باشد(از 60 امتیاز کلی) -هوشیاری نرمال بر اساس مقیاس کمای گلاسکو (امتیاز 15 از 15) - نظر متخصص بیهوشی یا فلوشیپ مراقبت های ویژه - شرح حال بستری در ICU بیش از 48 ساعت( با و بدون نیاز به ونتیلاسیون مکانیکی)
تشخیص قطعی کروناویروس بر اساس تست واکنش زنجیره ای پلیمراز یا سی تی اسکن ریه و نظر متخصص مربوطه
تشخیص ضعف اکتسابی ناشی از بستری در بخش مراقبت های ویژه بر اساس معیارهای زیر: -مجموع امتیاز قدرت عضلانی 6گروه عضلانی به صورت دو طرفه (فلکسیون ساعد، اکستانسیون مچ دست، فلکسیون ران، اکستانسیون زانو، درسال فلکسیون مچ پا، ابداکسیون بازو) در معاینه ی دستی بر طبق معیار انجمن تحقیقات پزشکی کمتر از 48 باشد(از 60 امتیاز کلی) -هوشیاری نرمال بر اساس مقیاس کمای گلاسکو (امتیاز 15 از 15) - نظر متخصص بیهوشی یا فلوشیپ مراقبت های ویژه - شرح حال بستری در ICU بیش از 48 ساعت( با و بدون نیاز به ونتیلاسیون مکانیکی)
تشخیص قطعی کروناویروس بر اساس تست واکنش زنجیره ای پلیمراز یا سی تی اسکن ریه و نظر متخصص مربوطه تشخیص ضعف اکتسابی ناشی از بستری در بخش مراقبت های ویژه بر اساس معیارهای زیر: -مجموع امتیاز قدرت عضلانی 6گروه عضلانی به صورت دو طرفه(فلکسیون ساعد، اکستانسیون مچ دست، فلکسیون ران، اکستانسیون زانو، درسال فلکسیون مچ پا، ابداکسیون بازو) در معاینه ی دستی بر طبق معیار انجمن تحقیقات پزشکی کمتر از 48 باشد(از 60 امتیاز کلی) -هوشیاری نرمال بر اساس مقیاس کمای گلاسکو (امتیاز 15 از 15) - نظر متخصص بیهوشی یا فلوشیپ مراقبت های ویژه - شرح حال بستری در ICU بیش از 48 ساعت( با و بدون نیاز به ونتیلاسیون مکانیکی)
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)
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)
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)
عدم هوشیاری
هایپرتنشن کنترل نشده یعنی: فشارخون سیستولیک در حالت استراحت بالاتر 180 میلی متر جیوه و/یا فشارخون دیاستولیک در حالت استراحت بالاتر از 110 میلی متر جیوه
درد سینه
تاکی کاردی سینوسی کنترل نشده (ضربان قلب بالای 120 ضربه در دقیقه )یا برادی کاردی سینوسی(ضربان قلب کتر از 60 ضربان در دقیقه)
وجود بیماری هم زمان قلبی مانند:نارسایی قلبی جبران نشده و شواهد بیماری ایسکمیک قلبی، آریتمی علامتدار
هایپوکسی در زمان استراحت(اشباع اکسیژن کتر از 88% )
هایپرتنشن شریان پولموناری(فشار شریان پولموناری بالاتر از 30 میلی متر جیوه)
تب یا بیماری سیستمیک حاد
.دیابت کنترل نشده
مشکلات ارتوپدی یا نورولوژیک شدیدی که مانع از ورزش می شوند
سایر شرایط متابولیک مانند:تیروییدیت حاد،هایپر کالمی،هایپوکالمی و هایپوولمی(تا زمان درمان کافی)
اختلالات سایکولوژیک شدید
پذیرش ضعیف بیمار
مشکلات نقل و انتقال بیمار به مرکز بازتوانی
غیبت بیمار از جلسات بازتوانی(بیش از 2 جلسه)
عدم هوشیاری
هایپرتنشن کنترل نشده یعنی: فشارخون سیستولیک در حالت استراحت بالاتر 180 میلی متر جیوه و/یا فشارخون دیاستولیک در حالت استراحت بالاتر از 110 میلی متر جیوه
درد سینه
تاکی کاردی سینوسی کنترل نشده (ضربان قلب بالای 120 ضربه در دقیقه )یا برادی کاردی سینوسی(ضربان قلب کتر از 60 ضربان در دقیقه)
وجود بیماری هم زمان قلبی مانند:نارسایی قلبی جبران نشده و شواهد بیماری ایسکمیک قلبی، آریتمی علامتدار
هایپوکسی در زمان استراحت(اشباع اکسیژن کتر از 88% )
هایپرتنشن شریان پولموناری(فشار شریان پولموناری بالاتر از 30 میلی متر جیوه)
تب یا بیماری سیستمیک حاد
.دیابت کنترل نشده
مشکلات ارتوپدی یا نورولوژیک شدیدی که مانع از ورزش می شوند
سایر شرایط متابولیک مانند:تیروییدیت حاد،هایپر کالمی،هایپوکالمی و هایپوولمی(تا زمان درمان کافی)
اختلالات سایکولوژیک شدید
پذیرش ضعیف بیمار
مشکلات نقل و انتقال بیمار به مرکز بازتوانی
غیبت بیمار از جلسات بازتوانی(بیش از 2 جلسه)
عدم هوشیاری هایپرتنشن کنترل نشده یعنی: فشارخون سیستولیک در حالت استراحت بالاتر 180 میلی متر جیوه و/یا فشارخون دیاستولیک در حالت استراحت بالاتر از 110 میلی متر جیوه درد سینه تاکی کاردی سینوسی کنترل نشده (ضربان قلب بالای 120 ضربه در دقیقه )یا برادی کاردی سینوسی(ضربان قلب کتر از 60 ضربان در دقیقه) وجود بیماری هم زمان قلبی مانند:نارسایی قلبی جبران نشده و شواهد بیماری ایسکمیک قلبی، آریتمی علامتدار هایپوکسی در زمان استراحت(اشباع اکسیژن کتر از 88% ) هایپرتنشن شریان پولموناری(فشار شریان پولموناری بالاتر از 30 میلی متر جیوه) تب یا بیماری سیستمیک حاد .دیابت کنترل نشده مشکلات ارتوپدی یا نورولوژیک شدیدی که مانع از ورزش می شوند سایر شرایط متابولیک مانند:تیروییدیت حاد،هایپر کالمی،هایپوکالمی و هایپوولمی(تا زمان درمان کافی) اختلالات سایکولوژیک شدید پذیرش ضعیف بیمار مشکلات نقل و انتقال بیمار به مرکز بازتوانی غیبت بیمار از جلسات بازتوانی(بیش از 2 جلسه)
Recruitment centers
#1
Name of recruitment center - English: Emam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: عاطفه نجفی
Full name of responsible person - Persian: Atefeh Najafi
Street address - English: Razi Ave, Sari, Mazandaran
Street address - Persian: ساری ، خیابان رازی ، مرکز آموزشی درمانی امام خمینی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: ۳۳۱۳۱ ۴۸۱۶۶
Phone: +98 11 3335 0670
Fax:
Email: hanieadib@gmail.com
Web page address:
Name of recruitment center - English: Imam Khomeini Hospital
Name of recruitment center - Persian: بیمارستان امام خمینی
Full name of responsible person - English: Atefeh Najafi
Full name of responsible person - Persian: عاطفه نجفی
Street address - English: Sari, Amir Mazandarani St., Imam Khomeini Hospital
Street address - Persian: ساری، خیابان امیرمازندرانی، بیمارستان امام خمینی
City - English: Sari
City - Persian: ساری
Province: Mazandaran
Country: Iran (Islamic Republic of)
Postal code: ۳۳۱۳۱ ۴۸۱۶۶
Phone: +98 11 3304 4000
Fax:
Email: hanieadib@gmail.com
Web page address:
Name of recruitment center - English: EmamImam Khomeini Hospital Name of recruitment center - Persian: بیمارستان امام خمینی Full name of responsible person - English: عاطفه نجفیAtefeh Najafi Full name of responsible person - Persian: Atefeh Najafiعاطفه نجفی Street address - English: Razi Ave, Sari, MazandaranAmir Mazandarani St., Imam Khomeini Hospital Street address - Persian: ساری، خیابان رازی امیرمازندرانی، مرکز آموزشی درمانیبیمارستان امام خمینی City - English: Sari City - Persian: ساری Province: Mazandaran Country: Iran (Islamic Republic of) Postal code: ۳۳۱۳۱ ۴۸۱۶۶ Phone: +98 11 3335 06703304 4000 Fax: Email: hanieadib@gmail.com Web page address:
Protocol summary
Study aim
Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired Weakness following COVID-19 infection
Design
Quasi-experimental clinical trial, without control group, without blinding and randomization, on 27 patients
Settings and conduct
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.
Participants/Inclusion and exclusion criteria
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
Intervention groups
Patients with COVID-19 with a history of ICU admission, with Or without Mechanical ventilation, with ICU Acquired Weakness diagnosis
Main outcome variables
Peripheral muscle strength; Respiratory muscle strength; Quality of life
General information
Reason for update
Due to the mismatch between the predicted and realized dates for sample collection
Acronym
IRCT registration information
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
Registration date
2021-08-05, 1400/05/14
Registrant information
Name
Hanieh Adib
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3326 4163
Email address
hanieadib@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-20, 1399/01/01
Expected recruitment end date
2021-09-22, 1400/06/31
Actual recruitment start date
2021-08-06, 1400/05/15
Actual recruitment end date
2022-01-05, 1400/10/15
Trial completion date
2022-03-06, 1400/12/15
Scientific title
Evaluation effects of multimodal rehabilitation on recovery of ICU Acquired weakness following coronavirus infection(COVID-19)
Public title
"Effects of multimodal rehabilitation on recovery of ICU Acquired weakness following COVID-19"
Purpose
Supportive
Inclusion/Exclusion criteria
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)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
27
Actual sample size reached:
27
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of the Vice Chancellor for Research and Technology of Mazandaran University of Med
Street address
Moallem Square, Vice Chancellor for Research and Technology, Mazandaran University of Medical Sciences
City
Sari
Province
Mazandaran
Postal code
4815733971
Approval date
2020-09-19, 1399/06/29
Ethics committee reference number
IR.MAZUMS.REC.1400.148
Health conditions studied
1
Description of health condition studied
Novel Coronavirus(COVID-19)
ICD-10 code
U07.1
ICD-10 code description
Clinically-epidemiologically diagnosed COVID-19
2
Description of health condition studied
Intensive Care Unit Acquired Weakness
ICD-10 code
G72.81
ICD-10 code description
Critical illness myopathy
Primary outcomes
1
Description
Quality of life
Timepoint
Before the intervention and after the intervention (after 16th session)
Method of measurement
World Health Organization Questionnaire
2
Description
Peripheral muscle force
Timepoint
Before the intervention and after the intervention (after 16th session)
Method of measurement
Medical Research Council grading system
Secondary outcomes
1
Description
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
2
Description
Ability to perform activity of daily living(ADL)
Timepoint
Before the intervention and after the intervention (after 16th session)
Method of measurement
Katz Questionnaire
3
Description
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
4
Description
Evaluation of muscle mass changes
Timepoint
Before the intervention and after the intervention (after 16th session)
Method of measurement
Bioelectrical impedance analysis device( BIA)
5
Description
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
6
Description
Evaluation of changes in Exercise capacity
Timepoint
Before the intervention and after the intervention (after 16th session)
Method of measurement
6 Minutes walk test
Intervention groups
1
Description
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.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Hospital
Full name of responsible person
Atefeh Najafi
Street address
Sari, Amir Mazandarani St., Imam Khomeini Hospital
City
Sari
Province
Mazandaran
Postal code
۳۳۱۳۱ ۴۸۱۶۶
Phone
+98 11 3304 4000
Email
hanieadib@gmail.com
Web page address
2
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Hanie Adib
Street address
Yousef Reza Ave, Ghaemshahr, Mazandaran
City
Qaemshahr
Province
Mazandaran
Postal code
۴۵۶۵۶۸۶۱۴۳
Phone
+98 11 4221 8018
Email
razi-ghh@mazums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeeidi
Street address
Moallem Square, Department of Research and Technology
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajoheshi@mazums.ac.ir
Grant name
1290004
Grant code / Reference number
۱۶۰۲۰۰۱۰۰۰
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanie Adib
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hanieadib@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanie Adib
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hanieadib@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Hanie Adib
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Sport Medicine
Street address
No 6, 3th Ave, Razi St, Mostafavian Clinic , Sports Medicine Clinic
City
Sari
Province
Mazandaran
Postal code
4816868890
Phone
+98 11 3336 6552
Email
hanieadib@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All recorded data will be reachable for clinical and academic researchers for one year after the article publications as non-identifiable files
When the data will become available and for how long
Accessibility to the data will be possible 6 months after the article publication for the applicants, for one year.
To whom data/document is available
Academic researchers and clinicians
Under which criteria data/document could be used
It is allowed only with the permission of the head researcher, and with the condition of participating in the research.
From where data/document is obtainable
Refer to the Email Address of the researchers:
hanieadib@gmail.com
atefehnajafi66102@gmail.com
What processes are involved for a request to access data/document
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.