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Protocol summary
People with diabetic sarcopenia are randomly (with block randomization method) divided into intervention group (with whole body vibration) and control group (without vibration). The clinical trial has a randomized control group with a sample size of 40. There is no trial phase.
People with diabetic sarcopenia are randomly (with block randomization method) divided into intervention group (with whole body vibration) and control group (without vibration). The clinical trial has a randomized control group with a sample size of 60. There is no trial phase.
People with diabetic sarcopenia are randomly (with block randomization method) divided into intervention group (with whole body vibration) and control group (without vibration). The clinical trial has a randomized control group with a sample size of 4060. There is no trial phase.
افراد دارای دیابتیک سارکوپنیا به صورت تصادفی (به روش بلوکبندی) به دو گروه مداخله (با ویبراسیون کل بدن) و کنترل (بدون ویبراسیون) تقسیم میشوند. کارآزمایی بالینی دارای گروه کنترل، تصادفیشده با حجم نمونه 40 است. فاز کارآزمایی مصداق ندارد.
افراد دارای دیابتیک سارکوپنیا به صورت تصادفی (به روش بلوکبندی) به دو گروه مداخله (با ویبراسیون کل بدن) و کنترل (بدون ویبراسیون) تقسیم میشوند. کارآزمایی بالینی دارای گروه کنترل، تصادفیشده با حجم نمونه 60 است. فاز کارآزمایی مصداق ندارد.
افراد دارای دیابتیک سارکوپنیا به صورت تصادفی (به روش بلوکبندی) به دو گروه مداخله (با ویبراسیون کل بدن) و کنترل (بدون ویبراسیون) تقسیم میشوند. کارآزمایی بالینی دارای گروه کنترل، تصادفیشده با حجم نمونه 4060 است. فاز کارآزمایی مصداق ندارد.
This study would be conducted at the Movement Disorders Research Center of Tarbiat Modares University and the Endocrine Center of Tehran University of Medical Sciences. The subjects under study are patients with diabetic sarcopenia. The study is single blind in which the assessor is not aware of the grouping.
This study would be conducted at the Movement Disorders Research Center of Tarbiat Modares University and the Endocrine Center of Tehran University of Medical Sciences. The subjects under study are patients with diabetic sarcopenia.
This study would be conducted at the Movement Disorders Research Center of Tarbiat Modares University and the Endocrine Center of Tehran University of Medical Sciences. The subjects under study are patients with diabetic sarcopenia. The study is single blind in which the assessor is not aware of the grouping.
این مطالعه در مرکز تحقیقات اختلالات حرکتی دانشگاه تربیت مدرس و مرکز تحقیقات غدد دانشگاه تهران انجام میپذیرد. جمعیت مورد مطالعه افراد مبتلا به دیابتیک سارکوپنیا میباشند. مطالعه یک سوکور و با عدم آگاهی ارزیابیکننده از گروهبندی میباشد.
این مطالعه در مرکز تحقیقات اختلالات حرکتی دانشگاه تربیت مدرس و مرکز تحقیقات غدد دانشگاه تهران انجام میپذیرد. جمعیت مورد مطالعه افراد مبتلا به دیابتیک سارکوپنیا میباشند.
این مطالعه در مرکز تحقیقات اختلالات حرکتی دانشگاه تربیت مدرس و مرکز تحقیقات غدد دانشگاه تهران انجام میپذیرد. جمعیت مورد مطالعه افراد مبتلا به دیابتیک سارکوپنیا میباشند. مطالعه یک سوکور و با عدم آگاهی ارزیابیکننده از گروهبندی میباشد.
Inclusion criteria: Diabetic patients who have been diagnosed for at least 6 months and are diagnosed with sarcopenia according to the diagnostic parameters; age between 45 to 78 years old; without osteoporosis and vitamin D deficiency.
Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
Inclusion criteria: Diabetic patients who have been diagnosed for at least 6 months and are diagnosed with sarcopenia according to the diagnostic parameters; age between 60 to 80 years old;
Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
Inclusion criteria: Diabetic patients who have been diagnosed for at least 6 months and are diagnosed with sarcopenia according to the diagnostic parameters; age between 4560 to 7880 years old; without osteoporosis and vitamin D deficiency. Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
شرایط ورود: بیماران دیابتی که حداقل 6 ماه از تشخیص آن گذشته باشد و مطابق پارامترهای تشخیصی سارکوپنیک تشخیص داده شوند؛ بین 45 تا 78 سال سن؛ بدون ابتلا به پوکی استخوان و کاهش ویتامین دی.
شرایط عدم ورود: سابقه ایسکمی حاد در 6 ماه گذشته؛ نمره GFR بالای 30؛ نمره نوروپاتی بالای 13؛ ابتلا به مشکلات تیروئیدی.
شرایط ورود: بیماران دیابتی که حداقل 6 ماه از تشخیص آن گذشته باشد و مطابق پارامترهای تشخیصی سارکوپنیک تشخیص داده شوند؛ بین 60 تا 80 سال سن؛
شرایط عدم ورود: سابقه ایسکمی حاد در 6 ماه گذشته؛ نمره GFR بالای 30؛ نمره نوروپاتی بالای 13؛ ابتلا به مشکلات تیروئیدی.
شرایط ورود: بیماران دیابتی که حداقل 6 ماه از تشخیص آن گذشته باشد و مطابق پارامترهای تشخیصی سارکوپنیک تشخیص داده شوند؛ بین 4560 تا 7880 سال سن؛ بدون ابتلا به پوکی استخوان و کاهش ویتامین دی. شرایط عدم ورود: سابقه ایسکمی حاد در 6 ماه گذشته؛ نمره GFR بالای 30؛ نمره نوروپاتی بالای 13؛ ابتلا به مشکلات تیروئیدی.
The intervention group will receive 8 weeks of whole body vibration. The control group will receive any intervention during 8 weeks.
The intervention group will receive 12 weeks of whole body vibration. The control group will receive any intervention during 12 weeks.
The intervention group will receive 812 weeks of whole body vibration. The control group will receive any intervention during 812 weeks.
گروه مداخله، 8 هفته ویبراسیون کل بدن دریافت خواهند کرد. گروه کنترل هیچ گونه مداخلهای در طی 8 هفته انجام نخواهد داد.
گروه مداخله، 12هفته ویبراسیون کل بدن دریافت خواهند کرد. گروه کنترل هیچ گونه مداخلهای در طی 12 هفته انجام نخواهد داد.
گروه مداخله، 8 هفته12هفته ویبراسیون کل بدن دریافت خواهند کرد. گروه کنترل هیچ گونه مداخلهای در طی 812 هفته انجام نخواهد داد.
Ground Reaction Force parameters, body sway parameters, TNF-a, IL-6, FBS, A1c and HSCRP factors
Ground Reaction Force parameters, body sway parameters, quality of life questioner , body mass parameters
Ground Reaction Force parameters, body sway parameters, TNF-aquality of life questioner , IL-6, FBS, A1c and HSCRP factorsbody mass parameters
پارامترهای نیروی عکس العمل زمین ،پارامترهای نوسان بدن ، فاکتورهای HbA1c ،FBS ،IL-6 ،TNF-a و HSCRP
پارامترهای نیروی عکس العمل زمین، پارامترهای نوسان بدن،پرسشنامه کیفیت زندگی،پارامترهای توده بدن
پارامترهای نیروی عکس العمل زمین،پارامترهای نوسان بدن، فاکتورهای HbA1c پرسشنامه کیفیت زندگی،FBS ،IL-6 ،TNF-a و HSCRPپارامترهای توده بدن
General information
45
60
4560
78
80
7880
Double blinded
Not blinded
doublnotbl
1
1
1
1
40
60
4060
2023-12-22, 1402/10/01
2024-01-20, 1402/10/30
20232024-1201-2220 00:00:00
2024-12-21, 1403/10/01
2025-07-21, 1404/04/30
20242025-1207-21 00:00:00
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بروز رسانی اطلاعات مطالعه
بروز رسانی اطلاعات مطالعه
At least 6 months history of diabetes
Diagnosis of sarcopenia in people with diabetes
Score less than 13 on Michigan Neuropathy Screening Instrument
Normal Vitamin D level
t-score above -2.5
At least 6 months history of diabetes
Diagnosis of sarcopenia in people with diabetes
Score less than 13 on Michigan Neuropathy Screening Instrument
At least 6 months history of diabetes Diagnosis of sarcopenia in people with diabetes Score less than 13 on Michigan Neuropathy Screening Instrument Normal Vitamin D level t-score above -2.5
حداقل 6 ماه سابقه ابتلا به دیابت
تشخیص سارکوپنی در افراد مبتلا به دیابت
نمره کمتر از 13 در نوروپاتی میشیگان
نرمال بودن سطح ویتامین دی
نمره t-score بالای 2.5-
حداقل 6 ماه سابقه ابتلا به دیابت
تشخیص سارکوپنی در افراد مبتلا به دیابت
نمره کمتر از 13 در نوروپاتی میشیگان
حداقل 6 ماه سابقه ابتلا به دیابت تشخیص سارکوپنی در افراد مبتلا به دیابت نمره کمتر از 13 در نوروپاتی میشیگان نرمال بودن سطح ویتامین دی نمره t-score بالای 2.5-
The person registering the laboratory data and the participants in the project are not aware of the allocation of study groups.
The person registering the laboratory data and the participants in the project are not aware of the allocation of study groups.
فرد ثبتکننده دادههای آزمایشگاهی و شرکتکننده در طرح از تخصیص گروههای مطالعه، مطلع نیستند.
فرد ثبتکننده دادههای آزمایشگاهی و شرکتکننده در طرح از تخصیص گروههای مطالعه، مطلع نیستند.
Primary outcomes
#1
Before and after 8 weeks of intervention
Before and after 12 weeks of intervention
Before and after 812 weeks of intervention
قبل و بعد از 8 هفته مداخله
قبل و بعد از 12 هفته مداخله
قبل و بعد از 812 هفته مداخله
#2
fasting blood sugar (FBS)
Quality of Life Index
fasting blood sugar (FBS)Quality of Life Index
قند خون ناشتا (FBS)
شاخص کیفیت زندگی
قند خون ناشتا (FBS)شاخص کیفیت زندگی
Before and after 8 weeks of intervention
Before and after 12 weeks of interventions
Before and after 812 weeks of interventioninterventions
قبل و بعد از 8 هفته مداخله
قبل و بعد از 12هفته مداخله
قبل و بعد از 8 هفته12هفته مداخله
Blood test
SarQoL questionnaire
Blood testSarQoL questionnaire
آزمایش خون
پرسشنامه سارکل
آزمایش خونپرسشنامه سارکل
#3
Quality of Life Index
Parameters of the body sway
QualityParameters of Life Indexthe body sway
شاخص کیفیت زندگی
پارامترهای نوسان بدن
شاخص کیفیت زندگیپارامترهای نوسان بدن
Before and after 8 weeks of interventions
قبل و بعد از 12 هفته مداخله
Before and after 8 weeks of interventionsقبل و بعد از 12 هفته مداخله
قبل و بعد از 8 هفته مداخله
قبل و بعد از 12 هفته مداخله
قبل و بعد از 812 هفته مداخله
SarQoL questionnaire
Force plate
SarQoL questionnaireForce plate
پرسشنامه سارکل
صفحه نیرو
پرسشنامه سارکلصفحه نیرو
#4
Parameters of the body sway
body mass parameters
Parameters of the body swaymass parameters
پارامترهای نوسان بدن
پارامترهای توده بدن
پارامترهای نوسانتوده بدن
before and after 8 weeks of intervention
قبل و بعد از 12 هفته مداخله
before and after 8 weeks of interventionقبل و بعد از 12 هفته مداخله
لیپوپروتئین چگالی پائینهموگلوبین گلیکوزه شده (LDLA1C)
Before and after 8 weeks of intervention
Before and after 12 weeks of intervention
Before and after 812 weeks of intervention
قبل و بعد از 8 هفته مداخله
قبل و بعد از 12 هفته مداخله
قبل و بعد از 812 هفته مداخله
#5
High-density lipoprotein(HDL)
inflammation factors
High-density lipoprotein(HDL)inflammation factors
لیپوپروتئین چگالی بالا(HDL)
فاکتورهای التهابی
لیپوپروتئین چگالی بالا(HDL)فاکتورهای التهابی
Before and after 8 weeks of intervention
Before and after 12 weeks of intervention
Before and after 812 weeks of intervention
قبل و بعد از 8 هفته مداخله
قبل و بعد از 12 هفته مداخله
قبل و بعد از 812 هفته مداخله
Intervention groups
#1
Intervention group: The intervention consists of 8 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 8 weeks, 5 to 10 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 8 weeks, the final assessment session will be done in the laboratory like the first session.
Intervention group: The intervention consists of 12 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 12 weeks, 5 to 12 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis.
Intervention group: The intervention consists of 812 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 812 weeks, 5 to 1012 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 812 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis.
گروه مداخله: مداخله شامل 8 هفته ویبراسیون کل بدن در افراد مبتلا به دیابتیک سارکوپنی است. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی، تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. در جلسات بعدی افراد باید به مدت 8 هفته، با فرکانس 3 بار در هفته و هر بار بین 5 تا 10 ست ویبره با 60 ثانیه ویبره و 30 ثانیه استراحت، تحت مداخله قرار گیرند. پس از پایان 8 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شد.
گروه مداخله: مداخله شامل12 هفته ویبراسیون کل بدن در افراد مبتلا به دیابتیک سارکوپنی است. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی، تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. در جلسات بعدی افراد باید به مدت 12 هفته، با فرکانس 3 بار در هفته و هر بار بین 5 تا 12 ست ویبره با 60 ثانیه ویبره و 30 ثانیه استراحت، تحت مداخله قرار گیرند. پس از پایان 12 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شد.درصورتی که افراد 80% جلسات که شامل حداقل 30 جلسه درمانی را می شود تکمیل نمایند وارد آنالیز آماری می شوند.
گروه مداخله: مداخله شامل 8شامل12 هفته ویبراسیون کل بدن در افراد مبتلا به دیابتیک سارکوپنی است. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی، تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. در جلسات بعدی افراد باید به مدت 812 هفته، با فرکانس 3 بار در هفته و هر بار بین 5 تا 1012 ست ویبره با 60 ثانیه ویبره و 30 ثانیه استراحت، تحت مداخله قرار گیرند. پس از پایان 812 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شدشد.درصورتی که افراد 80% جلسات که شامل حداقل 30 جلسه درمانی را می شود تکمیل نمایند وارد آنالیز آماری می شوند.
#2
Control group: This group will not receive any vibration and the subjects will be evaluated before and after 8 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 8 weeks, the final assessment session will be done in the laboratory like the first session.
Control group: This group will not receive any vibration and the subjects will be evaluated before and after 12 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session.
Control group: This group will not receive any vibration and the subjects will be evaluated before and after 812 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 812 weeks, the final assessment session will be done in the laboratory like the first session.
گروه کنترل: این گروه هیچ گونه ویبرهای دریافت نخواهند کرد و آزمودنیها قبل و بعد از 8 هفته ارزیابی خواهند شد. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. پس از پایان 8 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شد.
گروه کنترل: این گروه هیچ گونه ویبرهای دریافت نخواهند کرد و آزمودنیها قبل و بعد از 12 هفته ارزیابی خواهند شد. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. پس از پایان12 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شد.
گروه کنترل: این گروه هیچ گونه ویبرهای دریافت نخواهند کرد و آزمودنیها قبل و بعد از 812 هفته ارزیابی خواهند شد. در جلسه اول، پس از ثبت اطلاعات اولیه و آشنا شدن با نحوه انجام تستها، آزمودنی تستهای بیومکانیکی و خونی را انجام داده و سپس متغیرها ثبت خواهند شد. پس از پایان 8پایان12 هفته، جلسه ارزیابی نهایی در آزمایشگاه مانند جلسه اول انجام خواهد شد.
Recruitment centers
#1
Name of recruitment center - English: Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Name of recruitment center - Persian: مرکز تحقیقاتی-درمانی اختلالات حرکتی دانشگاه تربیت مدرس
Full name of responsible person - English: Sahar Boozari
Full name of responsible person - Persian: سحربوذری
Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
Street address - Persian: بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 5053
Fax: +98 21 8800 6544
Email: s.boozari@modares.ac.ir
Web page address: http://ptmodares.ir
Name of recruitment center - English: Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Name of recruitment center - Persian: مرکز تحقیقاتی-درمانی اختلالات حرکتی دانشگاه تربیت مدرس
Full name of responsible person - English: Sahar Boozari
Full name of responsible person - Persian: سحر بوذری
Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
Street address - Persian: بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713116
Phone: +98 21 8288 5053
Fax: +98 21 8800 6544
Email: s.boozari@modares.ac.ir
Web page address: http://ptmodares.ir
Name of recruitment center - English: Research and Treatment Center for Movement Disorders of Tarbiat Modares University Name of recruitment center - Persian: مرکز تحقیقاتی-درمانی اختلالات حرکتی دانشگاه تربیت مدرس Full name of responsible person - English: Sahar Boozari Full name of responsible person - Persian: سحربوذریسحر بوذری Street address - English: Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway Street address - Persian: بزرگراه جلال آل احمد، پل نصر، دانشگاه تربیت مدرس City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713116 Phone: +98 21 8288 5053 Fax: +98 21 8800 6544 Email: s.boozari@modares.ac.ir Web page address: http://ptmodares.ir
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Name of organization / entity - Persian: پژوهشگاه علوم غدد و متابولیسم دانشکاه علوم پزشکی تهران
Full name of responsible person - English: azadeh shahbazi
Full name of responsible person - Persian: آزاده شهبازی
Street address - English: Endocrinology and Metabolism Research Institute, Next to Shariati Hospital, Jalal Al Ahmad Highway
Street address - Persian: بزرگراه جلال آل احمد،جنب بیمارستان دکتر شریعتی، پژوهشگاه علوم غدد و متابولیسم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713119
Phone: +98 21 8863 1298
Fax: +98 21 8822 0052
Email: azadehshahbazi1392@gmail.com
Web page address:
contact.organization_id:
Name of organization / entity - English: Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Name of organization / entity - Persian: پژوهشگاه علوم غدد و متابولیسم دانشکاه علوم پزشکی تهران
Full name of responsible person - English: Azadeh Shahbazi
Full name of responsible person - Persian: آزاده شهبازی
Street address - English: Endocrinology and Metabolism Research Institute, Next to Shariati Hospital, Jalal Al Ahmad Highway
Street address - Persian: بزرگراه جلال آل احمد،جنب بیمارستان دکتر شریعتی، پژوهشگاه علوم غدد و متابولیسم
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1411713119
Phone: +98 21 8863 1298
Fax: +98 21 8822 0052
Email: azadehshahbazi1392@gmail.com
Web page address:
contact.organization_id: Name of organization / entity - English: Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences Name of organization / entity - Persian: پژوهشگاه علوم غدد و متابولیسم دانشکاه علوم پزشکی تهران Full name of responsible person - English: azadeh shahbaziAzadeh Shahbazi Full name of responsible person - Persian: آزاده شهبازی Street address - English: Endocrinology and Metabolism Research Institute, Next to Shariati Hospital, Jalal Al Ahmad Highway Street address - Persian: بزرگراه جلال آل احمد،جنب بیمارستان دکتر شریعتی، پژوهشگاه علوم غدد و متابولیسم City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1411713119 Phone: +98 21 8863 1298 Fax: +98 21 8822 0052 Email: azadehshahbazi1392@gmail.com Web page address:
Protocol summary
Study aim
Investigating the effect of whole body vibration on muscle mass, muscle strength, biomechanical parameters of gait and balance, glucose metabolism factors and inflammatory factors in people with diabetic sarcopenia
Design
People with diabetic sarcopenia are randomly (with block randomization method) divided into intervention group (with whole body vibration) and control group (without vibration). The clinical trial has a randomized control group with a sample size of 60. There is no trial phase.
Settings and conduct
This study would be conducted at the Movement Disorders Research Center of Tarbiat Modares University and the Endocrine Center of Tehran University of Medical Sciences. The subjects under study are patients with diabetic sarcopenia.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Diabetic patients who have been diagnosed for at least 6 months and are diagnosed with sarcopenia according to the diagnostic parameters; age between 60 to 80 years old;
Exclusion criteria: History of acute ischemia in the past 6 months; GFR score above 30; neuropathy score above 13; suffering from thyroid problems.
Intervention groups
The intervention group will receive 12 weeks of whole body vibration. The control group will receive any intervention during 12 weeks.
Main outcome variables
Ground Reaction Force parameters, body sway parameters, quality of life questioner , body mass parameters
General information
Reason for update
Update study information
Acronym
IRCT registration information
IRCT registration number:IRCT20201128049511N6
Registration date:2024-01-16, 1402/10/26
Registration timing:prospective
Last update:2025-05-02, 1404/02/12
Update count:1
Registration date
2024-01-16, 1402/10/26
Registrant information
Name
Sahar Boozari
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 5053
Email address
s.boozari@modares.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-20, 1402/10/30
Expected recruitment end date
2025-07-21, 1404/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the effect of whole body vibration on muscle mass, biomechanical parameters and metabolic factors in diabetic patients with sarcopenia
Public title
The effect of whole body vibration on patients with diabetic sarcopenia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
At least 6 months history of diabetes
Diagnosis of sarcopenia in people with diabetes
Score less than 13 on Michigan Neuropathy Screening Instrument
Exclusion criteria:
Having thyroid disorders
GFR score above 30
History of acute ischemia such as infarction in less than 3 months
History of falling in the past year
Taking drugs and supplements that have known effects on the neuromuscular system (such as corticosteroids)
Age
From 60 years old to 80 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization in this study will be done by block randomization method. Participants will be randomly assigned into intervention or control groups. The size of blocks will be 4. Also, the blocks will be randomly placed in the envelopes. For random assignment, code 1 denotes the intervention group and code 0 denotes the control group in the envelopes. Subjects will choose an envelope and then, based on the chosen code, they are assigned to one of the groups.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tarbiat Modares University
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Approval date
2023-11-26, 1402/09/05
Ethics committee reference number
IR.MODARES.REC.1402.123
Health conditions studied
1
Description of health condition studied
Sarcopenia
ICD-10 code
M62.84
ICD-10 code description
Sarcopenia
2
Description of health condition studied
Type 2 diabetes
ICD-10 code
E11
ICD-10 code description
Type 2 diabetes mellitus
Primary outcomes
1
Description
Ground Reaction Force Parameters
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Force plate device
2
Description
Quality of Life Index
Timepoint
Before and after 12 weeks of interventions
Method of measurement
SarQoL questionnaire
3
Description
Parameters of the body sway
Timepoint
قبل و بعد از 12 هفته مداخله
Method of measurement
Force plate
4
Description
body mass parameters
Timepoint
قبل و بعد از 12 هفته مداخله
Method of measurement
DXA
Secondary outcomes
1
Description
Muscle strength
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Dynamometer
2
Description
lipid profile
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
3
Description
fasting blood sugar(FBS)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
4
Description
glycated hemoglobin (A1C)
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
5
Description
inflammation factors
Timepoint
Before and after 12 weeks of intervention
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: The intervention consists of 12 weeks of whole body vibration for individuals with diabetic sarcopenia. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subjects will perform biomechanical and blood tests and then the variables will be recorded. In the next sessions, people should perform 3 times a week for 12 weeks, 5 to 12 vibration sets each with 60 seconds of vibration and 30 seconds of rest. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session. If subjects complete 80% of the sessions, which includes at least 30 treatment sessions, they will be included in the statistical analysis.
Category
Treatment - Other
2
Description
Control group: This group will not receive any vibration and the subjects will be evaluated before and after 12 weeks. In the first session, after registering the basic information and getting familiar with how to perform the tests, the subject will perform biomechanical and blood tests and then the variables will be recorded. After the end of 12 weeks, the final assessment session will be done in the laboratory like the first session.
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Research and Treatment Center for Movement Disorders of Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Web page address
http://ptmodares.ir
2
Recruitment center
Name of recruitment center
Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences
Full name of responsible person
Gita Shafiee
Street address
Research Institute of Endocrinology and Metabolism, Tehran University of Medical Sciences ,Next to Dr. Shariati Hospital, Jalal Al ahmad Highw
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
gshafiee.endocrine@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
University of Tarbiat Modares
Full name of responsible person
Amir Abdollahzadeh
Street address
Tarbiat Modares University, Jalal Al Ahmad, Nasr Bridge
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 2009
Fax
+98 21 8288 3101
Email
Res@modares.ac.ir
Web page address
https://res.modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
University of Tarbiat Modares
Proportion provided by this source
50
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
2
Sponsor
Name of organization / entity
Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Full name of responsible person
Azadeh Shahbazi
Street address
Endocrinology and Metabolism Research Institute, Next to Shariati Hospital, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713119
Phone
+98 21 8863 1298
Fax
+98 21 8822 0052
Email
azadehshahbazi1392@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research Institute of Endocrinology and Metabolism, Tehran Faculty of Medical Sciences
Proportion provided by this source
50
Public or private sector
Private
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
The University of Tarbiat Modares
Full name of responsible person
Motahare Ababaf Behbahani
Position
Phd candidate
Latest degree
Master
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
m.behbahani@modares.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Sahar Boozari
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiotherapy
Street address
Tarbiat Modares University, Nasr Bridge, Jalal Al ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713116
Phone
+98 21 8288 5053
Fax
+98 21 8800 6544
Email
s.boozari@modares.ac.ir
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 the main outcome can be shared when the subjects be made unidentifiable.
When the data will become available and for how long
The access phase starts six months after the results publication
To whom data/document is available
Researchers in academic and research organizations will have access to the data.
Under which criteria data/document could be used
To do scientific research
From where data/document is obtainable
Sahar Boozari, Adress: Tarbiat Modares University; Jalal Al Ahmad Highway; Email: s.boozari@modares.ac.ir; Phone number: 00982182885053
What processes are involved for a request to access data/document
After sending the project plan and a complete evaluation of the persons and organizations involved in the project, the data will be sent following the approval.