Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in overweight moderate hemophilia A patients
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Protocol summary
Effects of six weeks aerobic, resistance, and combined exercises on cardiovascular risk factors in overweight moderate hemophilia A patients using inflammatory and anti-inflammatory markers
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area and muscle architecture, kinematic and kinetic parameters in overweight patients moderate hemophilia A
Effects of six weeks aerobic, resistance, and combined exercises on cardiovascular risk factorsinflammatory markers, anti-inflammatory markers, cross sectional area and muscle architecture, kinematic and kinetic parameters in overweight patients moderate hemophilia A patients using inflammatory and anti-inflammatory markers
بررسی تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر عوامل خطرساز قلبی عروقی در بیماران هموفیلی A متوسط دارای اضافهوزن در دامنه سنی 35 تا 55 سال با استفاده از شاخصهای التهابی و ضدالتهابی
بررسی تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر شاخصهای التهابی، ضدالتهابی، سطح مقطع و ساختار عضله، پارامترهای کینماتیک و کینتیک در بیماران هموفیلی A متوسط دارای اضافهوزن
بررسی تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر عوامل خطرساز قلبی عروقیشاخصهای التهابی، ضدالتهابی، سطح مقطع و ساختار عضله، پارامترهای کینماتیک و کینتیک در بیماران هموفیلی A متوسط دارای اضافهوزن در دامنه سنی 35 تا 55 سال با استفاده از شاخصهای التهابی و ضدالتهابی
A randomized, controlled, patient and blood sample assessor-blinded, six-week trial, three times weekly
A randomized, controlled, Blood sample, sonography, MRI, kinematic and kinetic assessor-blinded, six-week trial, three times weekly
A randomized, controlled, patientBlood sample, sonography, MRI, kinematic and blood samplekinetic assessor-blinded, six-week trial, three times weekly
کارازمایی بالینی دارای گروه کنترل، بیمار و ارزیابی کننده مارکرها کور، 6 هفته 3 بار در هفته ، تصادفی شده
کارازمایی بالینی دارای گروه کنترل، و ارزیابی کننده مارکرها، سونوگرافی و ام ار ای و پارامترهای کینماتیک و کینتیک کور، 6 هفته 3 بار در هفته ، تصادفی شده
کارازمایی بالینی دارای گروه کنترل، بیمار و ارزیابی کننده مارکرها، سونوگرافی و ام ار ای و پارامترهای کینماتیک و کینتیک کور، 6 هفته 3 بار در هفته ، تصادفی شده
After the participants had been carefully informed about the study protocol, they signed written informed consent. All patients and the person collecting and determining the blood samples were blinded to the grouping.The training done in the Department of Physiotherapy,School of Rehabilitation Sciences, IUMS.
The exercise training and parameters measurement are done in the Department of Physiotherapy,School of Rehabilitation Sciences, IUMS. Muscle thickness and pennation angle is measured using the B-mode ultrasound , cross sectional area using MRI (Axial planes) at 50% of the arm and thigh length. Kinematic parameters using motion analysis (vicon) and kinetic parameters using force plate (kistler) system are measured.
After the participants had been carefully informed about the study protocol, they signed written informed consent. All patientsThe exercise training and the person collecting and determining the blood samples were blinded to the grouping.The trainingparameters measurement are done in the Department of Physiotherapy,School of Rehabilitation Sciences, IUMS. Muscle thickness and pennation angle is measured using the B-mode ultrasound , cross sectional area using MRI (Axial planes) at 50% of the arm and thigh length. Kinematic parameters using motion analysis (vicon) and kinetic parameters using force plate (kistler) system are measured.
بعد از اگاهی بیماران در مورد پروتکل مطالعه، فرم رضایت را امضا کردند.همه بیماران و نمونه گیر و ارزیابی کننده مارکرها در مورد گروه بندی کور بودند.تمرینات در دپارتمان فیزیوتراپی دانشکده توانبخشی دانشگاه علوم پزشکی ایران انجام میشود
تمرین درمانی و اندازه گیری متغیرها در دپارتمان فیزیوتراپی دانشکده توانبخشی ایران انجام میشود. ضخامت عضلانی و زاویه فیبرها توسط التراسوند مود B و سطح مقطع عضله توسط ام ار ای ( پلن اگزیال) در 50 درصد طول ران و بازو اندازه گیری میشود. پارامترهای کینماتیک توسط سیستم اندازه کیری حرکت( وایکون) و پارامترهای کینتیک توسط سیستم صفحه نیرو (کیستلر ) اندازه گیری میشود.
بعد از اگاهی بیماران در مورد پروتکل مطالعه، فرم رضایت را امضا کردند.همه بیمارانتمرین درمانی و نمونه گیر و ارزیابی کننده مارکرها در مورد گروه بندی کور بودند.تمریناتاندازه گیری متغیرها در دپارتمان فیزیوتراپی دانشکده توانبخشی دانشگاه علوم پزشکی ایران انجام میشود. ضخامت عضلانی و زاویه فیبرها توسط التراسوند مود B و سطح مقطع عضله توسط ام ار ای ( پلن اگزیال) در 50 درصد طول ران و بازو اندازه گیری میشود. پارامترهای کینماتیک توسط سیستم اندازه کیری حرکت( وایکون) و پارامترهای کینتیک توسط سیستم صفحه نیرو (کیستلر ) اندازه گیری میشود.
Inclusion criteria:moderate haemophilia A (factor VIII 1% -5 %)؛aged 35–55 years; body mass index 25–30 kg/m2; no history of an inhibitor; sufficient and free pain range of motion (ROM) of upper and lower limb joints;
Exclusion criteria: presence of a target joint; participation in regular physical training activities (more than two times per week) in the previous six months; high blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
Inclusion criteria:moderate haemophilia A (factor VIII 1% -5 %)؛aged 35–55 years; body mass index 25–30 kg/m2; no history of an inhibitor; Total Hemophilia Joint Health Score (HJHS) ≤10, Factor VIII prophylaxis before and during treatment protocol
Exclusion criteria: Clinical signs of active bleeding; Participation in regular physical training activities (more than two times per week) in the previous six months; High blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
Inclusion criteria:moderate haemophilia A (factor VIII 1% -5 %)؛aged 35–55 years; body mass index 25–30 kg/m2; no history of an inhibitor; sufficientTotal Hemophilia Joint Health Score (HJHS) ≤10, Factor VIII prophylaxis before and free pain range of motion (ROM) of upper and lower limb joints;during treatment protocol Exclusion criteria: presenceClinical signs of a target jointactive bleeding; participationParticipation in regular physical training activities (more than two times per week) in the previous six months; highHigh blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
شرایط ورود: بیماران هموفیلی متوسط A ، سن بین 35 تا 55 سال، شاخص توده بدنی بین 25 تا 30، بدون سابقه مهارکننده، دامنه حرکتی کافی در مفاصل اندام فوقانی و تحتانی
شرایط خروج:وجود مفصل هدف ، شرکت در فعالیت فیزیک منظم (بیشتر از دو بار در هفته) در 6 ماه گذشته، فشار جون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10 mmHg)
شرایط ورود: بیماران هموفیلی متوسط A ، سن بین 35 تا 55 سال، شاخص توده بدنی بین 25 تا 30، بدون سابقه مهارکننده، نمره کل سلامت مفصل کمتر از 10، دریافت دوز پروفیلاکسی قبل و حین تمرینات
شرایط خروج:علامت کلینیکی خونریزی حاد ، شرکت در فعالیت فیزیک منظم (بیشتر از دو بار در هفته) در 6 ماه گذشته، فشار جون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10 mmHg)
شرایط ورود: بیماران هموفیلی متوسط A ، سن بین 35 تا 55 سال، شاخص توده بدنی بین 25 تا 30، بدون سابقه مهارکننده، دامنه حرکتی کافی در مفاصل اندام فوقانینمره کل سلامت مفصل کمتر از 10، دریافت دوز پروفیلاکسی قبل و تحتانیحین تمرینات شرایط خروج:وجود مفصل هدفعلامت کلینیکی خونریزی حاد ، شرکت در فعالیت فیزیک منظم (بیشتر از دو بار در هفته) در 6 ماه گذشته، فشار جون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10 mmHg)
IL-6, IL-10, TNF. hs-CRP, Adiponectine
IL-6, IL-10, TNF. hs-CRP, Adiponectine, muscle thickness, pennation angle, cross section area of biceps, triceps,vastus medialis and vastus lateralis, angular displacement and velocity of joints, mean and standard deviation, velocity and total displacement of center of pressure
IL-6, IL-10, TNF. hs-CRP, Adiponectine, muscle thickness, pennation angle, cross section area of biceps, triceps,vastus medialis and vastus lateralis, angular displacement and velocity of joints, mean and standard deviation, velocity and total displacement of center of pressure
اینترلوکین 6، اینترلوکین 10، تی ان اف الفا، سی ار پی، ادیپونکتین
اینترلوکین 6، اینترلوکین 10، تی ان اف الفا، سی ار پی، ادیپونکتین،ضخامت عضلانی، زاویه فیبر و سطح مقطع عضلات بای سپس ، تری سپس ، واستوس مدیالیس و واستوس لترالیس، جابجایی زاویه ای و سرعت مفاصل، میانگین و انحراف معیار، سرعت جابجایی و دامنه کل جابجایی مرکز فشار ،
اینترلوکین 6، اینترلوکین 10، تی ان اف الفا، سی ار پی، ادیپونکتین،ضخامت عضلانی، زاویه فیبر و سطح مقطع عضلات بای سپس ، تری سپس ، واستوس مدیالیس و واستوس لترالیس، جابجایی زاویه ای و سرعت مفاصل، میانگین و انحراف معیار، سرعت جابجایی و دامنه کل جابجایی مرکز فشار ،
General information
Treatment
Supportive
treatsupcr
48
50
4850
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Add previously Measured variables with the same proposal, material, methods and study population
Add previously Measured variables with the same proposal, material, methods and study population
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اضافه کردن متغیرهای اندازه گیری شده قبلی با همان پروپوزال، متد و جامعه مطالعه
اضافه کردن متغیرهای اندازه گیری شده قبلی با همان پروپوزال، متد و جامعه مطالعه
Effects of exercises on inflammatory and anti-inflammatory markers in moderate hemophilia A patients
Effects of exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in moderate hemophilia A patients
Effects of exercises on inflammatory andmarkers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in moderate hemophilia A patients
تاثیر تمرینات ورزشی بر شاخصهای التهابی و ضدالتهابی بیماران هموفیلی A متوسط
تاثیر تمرینات ورزشی بر شاخصهای التهابی ، ضدالتهابی، سطح مقطع و ساختار عضله، شاخص های کینماتیک و کینتیک بیماران هموفیلی A متوسط
تاثیر تمرینات ورزشی بر شاخصهای التهابی ، ضدالتهابی، سطح مقطع و ضدالتهابیساختار عضله، شاخص های کینماتیک و کینتیک بیماران هموفیلی A متوسط
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory and anti-inflammatory markers in overweight moderate hemophilia A patients
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in overweight moderate hemophilia A patients
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory andmarkers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in overweight moderate hemophilia A patients
تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر شاخصهای التهابی و ضدالتهابی بیماران هموفیلی A متوسط دارای اضافه وزن
تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر شاخصهای التهابی، ضدالتهابی،سطح مقطع و ساختار عضله، شاخص های کینماتیک و کینتیک بیماران هموفیلی A متوسط دارای اضافه وزن
تأثیر 6 هفته تمرینات هوازی، مقاومتی و ترکیبی بر شاخصهای التهابی، ضدالتهابی،سطح مقطع و ضدالتهابیساختار عضله، شاخص های کینماتیک و کینتیک بیماران هموفیلی A متوسط دارای اضافه وزن
men with moderate haemophilia A (factor VIII 1% -5 %)
aged 35–55 years;
body mass index 25–30 kg/m2;
no history of an inhibitor;
sufficient and free pain range of motion (ROM) of upper and lower limb joints;
Men with moderate haemophilia A (factor VIII 1% -5 %)
Aged 35–55 years;
Body mass index 25–30 kg/m2;
No history of an inhibitor;
Total Hemophilia Joint Health Score (HJHS) ≤10
Factor VIII prophylaxis before and during treatment protocol
menMen with moderate haemophilia A (factor VIII 1% -5 %) agedAged 35–55 years; bodyBody mass index 25–30 kg/m2; noNo history of an inhibitor; sufficientTotal Hemophilia Joint Health Score (HJHS) ≤10 Factor VIII prophylaxis before and free pain range of motion (ROM) of upper and lower limb joints;during treatment protocol
بیماران مرد هموفیلی متوسط A ( فاکتور 8 بین 1-5 %)
سن بین 35 تا 55 سال
شاخص توده بدنی بین 25 تا 30
بدون سابقه مهارکننده
دامنه حرکتی کافی در مفاصل اندام فوقانی و تحتانی
بیماران مرد هموفیلی متوسط A ( فاکتور 8 بین 1-5 %)
سن بین 35 تا 55 سال
شاخص توده بدنی بین 25 تا 30
بدون سابقه مهارکننده
نمره کل سلامت مفصل کمتر از 10
دریافت دوز پروفیلاکسی قبل و حین تمرینات
بیماران مرد هموفیلی متوسط A ( فاکتور 8 بین 1-5 %) سن بین 35 تا 55 سال شاخص توده بدنی بین 25 تا 30 بدون سابقه مهارکننده دامنه حرکتی کافی در مفاصل اندام فوقانینمره کل سلامت مفصل کمتر از 10 دریافت دوز پروفیلاکسی قبل و تحتانیحین تمرینات
presence of a target joint
participation in regular physical training activities (more than two times per week) in the previous six months
high blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
Clinical signs of active bleeding
Participation in regular physical training activities (more than two times per week) in the previous six months
High blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
presenceClinical signs of a target joint participationactive bleeding Participation in regular physical training activities (more than two times per week) in the previous six months highHigh blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
وجود مفصل هدف
شرکت در فعالیت فیزیک منظم (بیتشر از دو بار در هفته) در 6 ماه گذشته
فشار خون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10)
علامت کلینیکی خونریزی حاد
شرکت در فعالیت فیزیک منظم (بیتشر از دو بار در هفته) در 6 ماه گذشته
فشار خون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10)
وجود مفصل هدفعلامت کلینیکی خونریزی حاد شرکت در فعالیت فیزیک منظم (بیتشر از دو بار در هفته) در 6 ماه گذشته فشار خون بالا ( سیستول بیستر از 16 و دیاستول بیشتر از 10)
To avoid bias, randomization (using computerized blocks) was carried out by a colleague in the faculty who was not in our research team and this research project. He had no conflict of interest in this randomization process.
The probability sampling method is simple randomization.Randomization was performed by an external observer using closed envelopes in blocks of 8, each assigned to two subjects
To avoid bias, randomization (using computerized blocks)The probability sampling method is simple randomization.Randomization was carried outperformed by a colleaguean external observer using closed envelopes in the faculty who was not in our research team and this research project. He had no conflictblocks of interest in this randomization process.8, each assigned to two subjects
برای جلوگیری از bias تصادفی کردن با استفاده از (computerized blocks) توسط فردی که در مطالعه ما نبود انجام شد.
روش نمونهگیری، احتمالی به روش تصادفی ساده است. توسط یک همکار خارج از طرح، تصادفی کردن بر اساس پاکتهای در بسته در بلاک های 8تایی که در هر بلاک دو نفر به هر گروه اختصاص پیدا میکند، انجام میشود.
برای جلوگیریروش نمونهگیری، احتمالی به روش تصادفی ساده است. توسط یک همکار خارج از biasطرح، تصادفی کردن با استفاده از (computerized blocks) توسط فردیبر اساس پاکتهای در بسته در بلاک های 8تایی که در مطالعه ما نبودهر بلاک دو نفر به هر گروه اختصاص پیدا میکند، انجام شدمیشود.
The person collecting , determining the blood samples ( Variable) and Data Saftey and Monitoring Committee are blinded to the grouping, but the physiotherapist for training( researcher) and participants is not masked to the group assignment.
The person collecting , determining the blood samples, sonography
and MRI measurements, kinematic parameters, kinetic parameters and data analyser and Data Saftey and Monitoring Committee are blinded to the grouping, but the physiotherapist for training( researcher) and participants is not masked to the group assignment.
The person collecting , determining the blood samples ( Variable), sonography and MRI measurements, kinematic parameters, kinetic parameters and data analyser and Data Saftey and Monitoring Committee are blinded to the grouping, but the physiotherapist for training( researcher) and participants is not masked to the group assignment.
شخص نمونه گیر ، انالیز کننده نمونه خون (متغییر پیامد اولیه) و کمیته ایمنی و نظارت بر داده هانسبت به گروه بندی کور هستند ، اما فیزیوتراپیست مسول ورزش دادن (محقق) و شرکت کنندگان نسبت به گروه بندی کور نیستند.
شخص نمونه گیر ، انالیز کننده نمونه خون، مسئول اندازه گیری سونوگرافی و ام آر آی، پارامترهای کینماتیک و کینتیک و انالیز کننده اماری و کمیته ایمنی و نظارت بر داده هانسبت به گروه بندی کور هستند ، اما فیزیوتراپیست مسول ورزش دادن (محقق) و شرکت کنندگان نسبت به گروه بندی کور نیستند.
شخص نمونه گیر ، انالیز کننده نمونه خون (متغییر پیامد اولیه)، مسئول اندازه گیری سونوگرافی و ام آر آی، پارامترهای کینماتیک و کینتیک و انالیز کننده اماری و کمیته ایمنی و نظارت بر داده هانسبت به گروه بندی کور هستند ، اما فیزیوتراپیست مسول ورزش دادن (محقق) و شرکت کنندگان نسبت به گروه بندی کور نیستند.
Angular displacement and velocity of the knee and hip joints in three planes including sagital, frontal and transverse planes
Angular displacement and velocity of the knee and hip joints in three planes including sagital, frontal and transverse planes
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جابجایی و سرعت زاویه ای مفاصل زانو و ران در سه صفحه ساجیتال، فرونتال و عرضی
جابجایی و سرعت زاویه ای مفاصل زانو و ران در سه صفحه ساجیتال، فرونتال و عرضی
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Before and after six weeks exercise
Before and after six weeks exercise
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قبل از ورزش و 6 هفته بعد از ورزش
قبل از ورزش و 6 هفته بعد از ورزش
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Marking the knee and hip joints and recording by the camera of the motion analysis (Vicon)
Marking the knee and hip joints and recording by the camera of the motion analysis (Vicon)
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مارکر گذاری بر مفاصل زانو و ران و ثبت توسط دوربین دستگاه انالیز حرکتی (وایکون)
مارکر گذاری بر مفاصل زانو و ران و ثبت توسط دوربین دستگاه انالیز حرکتی (وایکون)
#9
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Mean, standard deviation, total displacement and velocity of center of pressure during walking and sit to stand in the frontal and sagital planes
Mean, standard deviation, total displacement and velocity of center of pressure during walking and sit to stand in the frontal and sagital planes
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میانگین ، انحراف معیار، دامنه کل و سرعت جابجایی مرکز فشار حین راه رفتن وایستادن از حالت نشسته در دو صفحه فرونتال و ساجیتال
میانگین ، انحراف معیار، دامنه کل و سرعت جابجایی مرکز فشار حین راه رفتن وایستادن از حالت نشسته در دو صفحه فرونتال و ساجیتال
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Before and after six weeks exercise
Before and after six weeks exercise
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قبل از ورزش و 6 هفته بعد از ورزش
قبل از ورزش و 6 هفته بعد از ورزش
empty
Force plate (Kistler) With a sampling rate of 100 Hz
Force plate (Kistler) With a sampling rate of 100 Hz
empty
صفحه نیرو (کیستلر) با نرخ نمونه گیری 100 هرتز
صفحه نیرو (کیستلر) با نرخ نمونه گیری 100 هرتز
Recruitment centers
#1
Name of recruitment center - English: Iraninan comprehensive hemophilia treatment center
Name of recruitment center - Persian: مرکز جامع درمان هموفیلی ایران
Full name of responsible person - English: behrouz parhampour
Full name of responsible person - Persian: بهروز پرهام پور
Street address - English: no 543, zartosht - phelestine street, fatemi square
Street address - Persian: میدان فاطمی، تقاطع فلسطین و زرتشت پلاک 543
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1415863675
Phone: +98 21 8891 0001
Fax:
Email: behrouz.parhampour@gmail.com
Web page address:
Name of recruitment center - English: Iraninan Comprehensive Hemophilia Treatment Center
Name of recruitment center - Persian: مرکز جامع درمان هموفیلی ایران
Full name of responsible person - English: Behrouz Parhampour
Full name of responsible person - Persian: بهروز پرهام پور
Street address - English: No 543, Zartosht - Phelestine Street, Fatemi Square
Street address - Persian: میدان فاطمی، تقاطع فلسطین و زرتشت پلاک 543
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1415863675
Phone: +98 21 8891 0001
Fax:
Email: behrouz.parhampour@gmail.com
Web page address:
Name of recruitment center - English: Iraninan comprehensive hemophilia treatment centerComprehensive Hemophilia Treatment Center Name of recruitment center - Persian: مرکز جامع درمان هموفیلی ایران Full name of responsible person - English: behrouz parhampourBehrouz Parhampour Full name of responsible person - Persian: بهروز پرهام پور Street address - English: noNo 543, zartoshtZartosht - phelestine streetPhelestine Street, fatemi squareFatemi Square Street address - Persian: میدان فاطمی، تقاطع فلسطین و زرتشت پلاک 543 City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1415863675 Phone: +98 21 8891 0001 Fax: Email: behrouz.parhampour@gmail.com Web page address:
Sponsors / Funding sources
#1
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: بهنوش وثاقی قراملکی
Full name of responsible person - Persian: behnoosh vasaghi ghramaleki
Street address - English: nezam alley, shahnazari street, mirdamad street, school of rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 8051
Fax:
Email: bvasaghi@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Mojtaba Kamyab
Full name of responsible person - Persian: مجتبی کامیاب
Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 2059
Fax:
Email: kamyab.m@iums.ac.ir
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: بهنوش وثاقی قراملکیMojtaba Kamyab Full name of responsible person - Persian: behnoosh vasaghi ghramalekiمجتبی کامیاب Street address - English: nezam alleyNezam Alley, shahnazari streetShahnazari Street, mirdamad streetMirdamad Street, schoolSchool of rehabilitationRehabilitation. IUMS Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران City - English: tehranTehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1545913187 Phone: +98 21 2222 80512059 Fax: Email: bvasaghikamyab.m@gmail.comiums.ac.ir Web page address:
Person responsible for general inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behnoosh Vasaghi Gharamaleki
Full name of responsible person - Persian: بهنوش وثاقی قراملکی
Position - English: Assisstance Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 8051
Mobile: +98 912 107 8632
Fax:
Email: bvasaghi@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behnoosh Vasaghi Gharamaleki
Full name of responsible person - Persian: بهنوش وثاقی قراملکی
Position - English: Assistance Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 8051
Mobile: +98 912 107 8632
Fax:
Email: bvasaghi@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Behnoosh Vasaghi Gharamaleki Full name of responsible person - Persian: بهنوش وثاقی قراملکی Position - English: AssisstanceAssistance Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 68 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1545913187 Phone: +98 21 2222 8051 Mobile: +98 912 107 8632 Fax: Email: bvasaghi@gmail.com Web page address:
Person responsible for scientific inquiries
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behnoosh Vasagh Gharamaleki
Full name of responsible person - Persian: بهنوش وثاقی قراملکی
Position - English: Assisstance Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 8051
Mobile: +98 912 107 8632
Fax:
Email: bvasaghi@gmail.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Behnoosh Vasagh Gharamaleki
Full name of responsible person - Persian: بهنوش وثاقی قراملکی
Position - English: Assistance Professor
Position - Persian: استادیار
Latest degree: phd
Area of specialty/work: 68
Area of specialty/work title - English:
Area of specialty/work title - Persian:
Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1545913187
Phone: +98 21 2222 8051
Mobile: +98 912 107 8632
Fax:
Email: bvasaghi@gmail.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Behnoosh Vasagh Gharamaleki Full name of responsible person - Persian: بهنوش وثاقی قراملکی Position - English: AssisstanceAssistance Professor Position - Persian: استادیار Latest degree: phd Area of specialty/work: 68 Area of specialty/work title - English: Area of specialty/work title - Persian: Street address - English: Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS Street address - Persian: خیابان میرداماد، خیابان شاه نظری، کوچه نظام، دانشکده توانبخشی دانشگاه علوم پزشکی ایران City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 1545913187 Phone: +98 21 2222 8051 Mobile: +98 912 107 8632 Fax: Email: bvasaghi@gmail.com Web page address:
Sharing plan
Information about serum markers
Information about serum markers, MSK sonography and MRI, kinematic and kinetic parameters
Information about serum markers, MSK sonography and MRI, kinematic and kinetic parameters
اطلاعات مرتبط با مارکرهای خونی
اطلاعات مرتبط با مارکرهای خونی، سونوگرافی و ام ار ای عضلانی، پارامترهای کینماتیک و کینتیک
اطلاعات مرتبط با مارکرهای خونی، سونوگرافی و ام ار ای عضلانی، پارامترهای کینماتیک و کینتیک
6 months after results printed
Starting 6 months after publication
Starting 6 months after results printedpublication
6 ماه بعد از چاپ نتایج
شروع دسترسی 6 ماه بعد از چاپ نتایج
شروع دسترسی 6 ماه بعد از چاپ نتایج
for investigation of effect of exercise with more time
Coopration for article publishing using our data for investigation of effect of exercise with more duration on the muscle cross section area and architecture, kinematic and kinetic parameters
Coopration for article publishing using our data for investigation of effect of exercise with more timeduration on the muscle cross section area and architecture, kinematic and kinetic parameters
برای بررسی تاثیر تمرینات ورزشی با زمان بیشتر
همکاری برای چاپ مقاله ای که از اطلاعات ما بدست میاد برای بررسی تاثیر تمرینات با مدت بیشتر بر روی مارکر ها،ساختار و سطح مقطع عضله، پارامترهای کینماتیک و کینتیک
همکاری برای چاپ مقاله ای که از اطلاعات ما بدست میاد برای بررسی تاثیر تمرینات ورزشی با زمانمدت بیشتر بر روی مارکر ها،ساختار و سطح مقطع عضله، پارامترهای کینماتیک و کینتیک
Behrouz Parhampour
Behrouz Parhampour, first email and then call phone: 02144925035
behrouz.parhampour@gmail.com
Behrouz Parhampour, first email and then call phone: 02144925035 behrouz.parhampour@gmail.com
بهروز پرهام پور
بهروز پرهام پور، ابتدا از طریق ایمیل و سپس تماس تلفنی 02144925035،
behrouz.parhampour@gmail.com
بهروز پرهام پور، ابتدا از طریق ایمیل و سپس تماس تلفنی 02144925035، behrouz.parhampour@gmail.com
Protocol summary
Study aim
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area and muscle architecture, kinematic and kinetic parameters in overweight patients moderate hemophilia A
Design
A randomized, controlled, Blood sample, sonography, MRI, kinematic and kinetic assessor-blinded, six-week trial, three times weekly
Settings and conduct
The exercise training and parameters measurement are done in the Department of Physiotherapy,School of Rehabilitation Sciences, IUMS. Muscle thickness and pennation angle is measured using the B-mode ultrasound , cross sectional area using MRI (Axial planes) at 50% of the arm and thigh length. Kinematic parameters using motion analysis (vicon) and kinetic parameters using force plate (kistler) system are measured.
Participants/Inclusion and exclusion criteria
Inclusion criteria:moderate haemophilia A (factor VIII 1% -5 %)؛aged 35–55 years; body mass index 25–30 kg/m2; no history of an inhibitor; Total Hemophilia Joint Health Score (HJHS) ≤10, Factor VIII prophylaxis before and during treatment protocol
Exclusion criteria: Clinical signs of active bleeding; Participation in regular physical training activities (more than two times per week) in the previous six months; High blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
Intervention groups
Resistance Exercise Group
Aerobic Exercise Group
Combined Exercise Group
Control Group
Main outcome variables
IL-6, IL-10, TNF. hs-CRP, Adiponectine, muscle thickness, pennation angle, cross section area of biceps, triceps,vastus medialis and vastus lateralis, angular displacement and velocity of joints, mean and standard deviation, velocity and total displacement of center of pressure
General information
Reason for update
Add previously Measured variables with the same proposal, material, methods and study population
Acronym
IRCT registration information
IRCT registration number:IRCT20180128038541N1
Registration date:2018-02-13, 1396/11/24
Registration timing:retrospective
Last update:2020-04-23, 1399/02/04
Update count:1
Registration date
2018-02-13, 1396/11/24
Registrant information
Name
behrouz parhampour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2222 8051
Email address
behrouz.parhampour@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-10-21, 1396/07/29
Expected recruitment end date
2018-01-19, 1396/10/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of six weeks aerobic, resistance, and combined exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in overweight moderate hemophilia A patients
Public title
Effects of exercises on inflammatory markers, anti-inflammatory markers, cross sectional area , muscle architecture, kinematic and kinetic parameters in moderate hemophilia A patients
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Men with moderate haemophilia A (factor VIII 1% -5 %)
Aged 35–55 years;
Body mass index 25–30 kg/m2;
No history of an inhibitor;
Total Hemophilia Joint Health Score (HJHS) ≤10
Factor VIII prophylaxis before and during treatment protocol
Exclusion criteria:
Clinical signs of active bleeding
Participation in regular physical training activities (more than two times per week) in the previous six months
High blood pressure at rest (systolic >160 mmHg, diastolic >10 mmHg)
Age
From 35 years old to 55 years old
Gender
Male
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
The probability sampling method is simple randomization.Randomization was performed by an external observer using closed envelopes in blocks of 8, each assigned to two subjects
Blinding (investigator's opinion)
Single blinded
Blinding description
The person collecting , determining the blood samples, sonography
and MRI measurements, kinematic parameters, kinetic parameters and data analyser and Data Saftey and Monitoring Committee are blinded to the grouping, but the physiotherapist for training( researcher) and participants is not masked to the group assignment.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Sciences
Street address
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
City
Tehran
Province
Tehran
Postal code
1545913187
Approval date
2016-06-28, 1395/04/08
Ethics committee reference number
IR.IUMS.REC.1395.9211342206
Health conditions studied
1
Description of health condition studied
Moderate Hemophilia A
ICD-10 code
D66
ICD-10 code description
Hereditary factor VIII deficiency
Primary outcomes
1
Description
IL-6: Inflammatory marker
Timepoint
Before and after six weeks exercise
Method of measurement
ELISA kit, Invitrogen, San Diego,USA
2
Description
TNF: Inflammatory marker
Timepoint
Before and after six weeks exercise
Method of measurement
ELISA kit, Invitrogen, San Diego,USA
3
Description
hs-CRP:Inflammatory marker
Timepoint
Before and after six weeks exercise
Method of measurement
ELISA kit, Invitrogen, San Diego,USA
4
Description
IL-10: Anti inflammatiry marker
Timepoint
Before and after six weeks exercise
Method of measurement
ELISA kit, Invitrogen, San Diego,USA
5
Description
Adiponectine: Anti inflammatiry marker
Timepoint
Before and after six weeks exercise
Method of measurement
ELISA kit, Invitrogen, San Diego,USA
6
Description
Muscle Thickness and pennation angle
Timepoint
Before and after six weeks exercise
Method of measurement
Ultrasonography, B mode
7
Description
Muscle cross sectional area
Timepoint
Before and after six weeks exercise
Method of measurement
Axial plane scans using MRI scanner
8
Description
Angular displacement and velocity of the knee and hip joints in three planes including sagital, frontal and transverse planes
Timepoint
Before and after six weeks exercise
Method of measurement
Marking the knee and hip joints and recording by the camera of the motion analysis (Vicon)
9
Description
Mean, standard deviation, total displacement and velocity of center of pressure during walking and sit to stand in the frontal and sagital planes
Timepoint
Before and after six weeks exercise
Method of measurement
Force plate (Kistler) With a sampling rate of 100 Hz
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Resistanve exercise: Resistance training group require to perform six weeks trunk, upper and lower limb exercises (65-75% 1RM) , 40 min per session , three days per week.Strength-training exercises consist of knee flexion, knee extension, shoulder press, chest press, leg press, calf raise, and squat. Subjects perform 10 repetitions of each exercise during the first, third and fifth weeks and 12 repetitions of each exercise during the second, fourth and sixth weeks of training.
Category
Rehabilitation
2
Description
Intervention group 2: Aerobic exercise: Aerobic exercise perform on treadmill and cycle ergometer . Aerobic exercise intensity is adjusted based on maximum heart rate (220 - age = MHR). In the first, second, and third of each two-week period, the target intensity is 65%, 70%, and 75% of MHR,respectively. Each exercise session consist of aerobic training on a treadmill for 22 minutes ,and cycle ergometer for 22 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followed by 12 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises.
Category
Rehabilitation
3
Description
Intervention group3: Combined exercise:In the combined resistance with aerobic training group, the intensity of the resistance exercises is similar to that for the resistance training group, but there is five repetitions of each exercise in the first, third, and fifth weeks and six repetitions during the second, fourth, and sixth weeks of training. After 22 minutes of aerobic exercises, patients perform 20 minutes resistance exercises. Each exercise session consisted of aerobic training on a treadmill for 11 minutes ,and cycle ergometer for 11 minutes. Each step include warm up, training at constant workload, and cool down. A 3-minute warm-up phase followe by 6 minutes training at constant workload phase and a 2-minute cool down phase is used for the aerobic exercises.
Category
Rehabilitation
4
Description
Control group: The control group is requested not to change their daily physical activity during the 6 weeks.
Category
Rehabilitation
Recruitment centers
1
Recruitment center
Name of recruitment center
Iraninan Comprehensive Hemophilia Treatment Center
Full name of responsible person
Behrouz Parhampour
Street address
No 543, Zartosht - Phelestine Street, Fatemi Square
City
Tehran
Province
Tehran
Postal code
1415863675
Phone
+98 21 8891 0001
Email
behrouz.parhampour@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Mojtaba Kamyab
Street address
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 2059
Email
kamyab.m@iums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University of Medical Sciences
Full name of responsible person
Behnoosh Vasaghi Gharamaleki
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
bvasaghi@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnoosh Vasagh Gharamaleki
Position
Assistance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
bvasaghi@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Behnoosh Vasagh Gharamaleki
Position
Assisstance Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Nezam Alley, Shahnazari Street, Mirdamad Street, School of Rehabilitation. IUMS
City
Tehran
Province
Tehran
Postal code
1545913187
Phone
+98 21 2222 8051
Email
bvasaghi@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
Information about serum markers, MSK sonography and MRI, kinematic and kinetic parameters
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
Physiotherapist and orthopadist related with hemophilia patients
Under which criteria data/document could be used
Coopration for article publishing using our data for investigation of effect of exercise with more duration on the muscle cross section area and architecture, kinematic and kinetic parameters
From where data/document is obtainable
Behrouz Parhampour, first email and then call phone: 02144925035
behrouz.parhampour@gmail.com
What processes are involved for a request to access data/document