History
# Registration date Revision Id
2 2026-02-07, 1404/11/18 371946
1 2025-08-16, 1404/05/25 351700
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  • Protocol summary

    The study, conducted at Razi University’s Metabolism and Exercise Performance Laboratory, uses a double-blind, within-subject design. Participants will complete cognitive tests, receive one of three stimulation conditions, perform a 15-km cycle ergometer endurance session, and have perceptual and physiological responses (pain, pleasure, arousal, perceived exertion, heart rate) measured.
    Participants will complete Stroop and choice reaction time tests before and after receiving electrical stimulation and performing an exhaustive cycling task. A one-minute countdown task will be administered at RPE 15. Perceptual–physiological variables (pain, pleasure, arousal, RPE, and heart rate) will be assessed every three minutes during exercise.
    مطالعه در آزمایشگاه متابولیسم و عملکرد ورزشی دانشکده علوم ورزشی دانشگاه رازی انجام خواهد شد، آزمودنی‌ها آزمون‌های شناختی استروپ رنگ-کلمه، زمان واکنش انتخابی و شمارش معکوس را اجرا نموده، سپس یکی از شرایط تحریک مذکور را دریافت و پس از آن یک وهله فعالیت استقامتی 15 کیلومتری روی چرخ‌کارسنج را انجام خواهند داد همچنین پاسخ‌های ادراکی- فیزیولوژیکی شامل حس درد، حس لذت، میزان انگیختگی، درک فشار و ضربان قلب نیز ارزیابی می‌شوند.
    آزمودنی‌ها آزمون‌های استروپ رنگ–کلمه و زمان واکنش انتخابی را پیش و پس از دریافت تحریک الکتریکی و اجرای یک وهله فعالیت رکابزنی وامانده‌ساز انجام خواهند داد. آزمون شمارش معکوس به‌مدت یک دقیقه در آستانه درک فشار 15 اجرا خواهد شد. متغیرهای ادراکی–فیزیولوژیکی شامل حس درد، حس لذت، میزان انگیختگی، درک فشار و ضربان قلب هر سه دقیقه در طول فعالیت ارزیابی می‌شوند.
    Inclusion Criteria: Age 18–29 years; male physical education students at Razi University, third semester or higher; body mass index (BMI) 18.5–24.9 kg/m²; right-handed. Exclusion Criteria: Presence of any cardiovascular, pulmonary, or metabolic disease; history of seizures, epilepsy, or other neurological disorders; presence of implanted medical devices or pacemakers; use of tobacco or alcohol; color blindness or other visual impairments.
    Inclusion Criteria: Age 18–29 years; male physical education students at Razi University, third semester or higher; body mass index (BMI) 18.5–24.9 kg/m²; right-handed. Exclusion Criteria: Presence of any cardiovascular, pulmonary, or metabolic disease; history of seizures, epilepsy, or other neurological disorders; presence of implanted medical devices or pacemakers; use of tobacco or alcohol; color blindness or other visual impairments.
  • General information

    empty
    The endurance testing protocol was modified from a 15-kilometer time-trial to a cycling endurance time to exhaustion test.
    empty
    پروتکل اجرای آزمون استقامتی، از تایم ترایل 15 کیلومتر به اجرای آزمون استقامتی رکابزنی تا رسیدن به واماندگی تغییر پیدا کرد.
    In each individual, the following samples/measurements are collected once per condition (tDCS, tPCS, sham), resulting in three sets per participant: Primary outcome 1. Endurance performance: time to complete a 15 km time-trial cycling test on a cycloergometer. 2. Cognitive performance measures: Stroop Color-Word Test results (color, word, and color-word interference scores), reaction time in the choice reaction time test, and countdown task performance (correct responses and accuracy). 3. Physiological and perceptual measures (taken during and/or immediately after exercise): Heart rate, Rating of perceived exertion (RPE), Pleasure rating, Arousal level, Pain perception. Each participant completes all measurements under all three stimulation conditions, with at least one week washout between sessions
    In each individual, the following samples/measurements are collected once per condition (tDCS, tPCS, sham), resulting in three sets per participant: Primary outcome 1. Endurance performance: time to exhaustion test on a cycloergometer. 2. Cognitive performance measures: Stroop Color-Word Test results (color, word, and color-word interference scores), reaction time in the choice reaction time test, and countdown task performance (correct responses and accuracy). 3. Physiological and perceptual measures (taken during and/or immediately after exercise): Heart rate, Rating of perceived exertion (RPE), Pleasure rating, Arousal level, Pain perception. Each participant completes all measurements under all three stimulation conditions, with at least 48 hours washout between sessions.
    در هر فرد، نمونه‌ها/اندازه‌گیری‌ها به‌صورت یک‌بار در هر شرایط مداخله‌ای tDCS، tPCS، شم انجام می‌شود و در نتیجه برای هر آزمودنی سه مجموعه داده ثبت خواهد شد:متغیر پیامد اولیه 1.عملکرد استقامتی: زمان لازم برای تکمیل آزمون تایم‌تریل دوچرخه‌سواری به مسافت ۱۵ کیلومتر بر روی دوچرخه کارسنج. 2.اندازه‌گیری‌های عملکرد شناختی: نتایج آزمون استروپ (امتیاز رنگ، کلمه و تداخل رنگ-کلمه)، زمان واکنش در آزمون زمان عکس‌العمل انتخابی، عملکرد در آزمون شمارش معکوس (تعداد پاسخ‌های صحیح و دقت). 3.اندازه‌گیری‌های فیزیولوژیکی و ادراکی: (حین و/یا بلافاصله پس از فعالیت)، ضربان قلب، میزان درک فشار (RPE)، حس لذت، سطح انگیختگی و حس درد. هر آزمودنی این اندازه‌گیری‌ها را تحت هر سه شرایط تحریک با فاصله حداقل یک هفته بین جلسات انجام می‌دهد.
    در هر فرد، نمونه‌ها/اندازه‌گیری‌ها به‌صورت یک‌بار در هر شرایط مداخله‌ای tDCS، tPCS، شم انجام می‌شود و در نتیجه برای هر آزمودنی سه مجموعه داده ثبت خواهد شد:متغیر پیامد اولیه 1.عملکرد استقامتی: آزمون تایم‌تریل رکابزنی تا رسیدن به واماندگی بر روی دوچرخه کارسنج. 2.اندازه‌گیری‌های عملکرد شناختی: نتایج آزمون استروپ (امتیاز رنگ، کلمه و تداخل رنگ-کلمه)، زمان واکنش در آزمون زمان عکس‌العمل انتخابی، عملکرد در آزمون شمارش معکوس (تعداد پاسخ‌های صحیح و دقت). 3.اندازه‌گیری‌های فیزیولوژیکی و ادراکی: (حین و/یا بلافاصله پس از فعالیت)، ضربان قلب، میزان درک فشار (RPE)، حس لذت، سطح انگیختگی و حس درد. هر آزمودنی این اندازه‌گیری‌ها را تحت هر سه شرایط تحریک با فاصله حداقل 48 ساعت بین جلسات انجام می‌دهد.
  • Primary outcomes

    #1
    The primary outcome variable is the endurance performance, specifically measured as the time taken to complete a 15 km time-trial cycling test.This is the main variable expected to change as a result of the interventions (tDCS, tPCS, or sham), and it is the outcome used for calculating the sample size.
    The primary outcome variable is the endurance performance, specifically measured as the time to exhaustion on ergometer cycling test. This is the main variable expected to change as a result of the interventions (tDCS, tPCS, or sham), and it is the outcome used for calculating the sample size.
    متغیر پیامد اولیه، عملکرد استقامتی است که به‌طور مشخص بر اساس زمان صرف‌شده برای تکمیل آزمون تایم‌تریل دوچرخه‌سواری به مسافت ۱۵ کیلومتر اندازه‌گیری می‌شود. این متغیر اصلی، مورد انتظار است که در اثر مداخلات (تحریک جریان مستقیم فراجمجمه‌ای، تحریک جریان پالسی فراجمجمه‌ای یا شرایط شم) دستخوش تغییر گردد و مبنای محاسبه حجم نمونه نیز قرار گرفته است.
    متغیر پیامد اولیه، عملکرد استقامتی است که به‌طور مشخص بر اساس زمان صرف‌شده برای تکمیل آزمون دوچرخه‌سواری بر اساس زمان رسیدن به واماندگی اندازه‌گیری می‌شود. این متغیر اصلی، مورد انتظار است که در اثر مداخلات (تحریک جریان الکتریکی مستقیم، پالسی یا شرایط شم) دستخوش تغییر گردد و مبنای محاسبه حجم نمونه نیز قرار گرفته است.
    The primary outcome (endurance performance – 15 km time-trial cycling time) is measured once in each experimental session, immediately after the application of the intervention (tDCS, tPCS, or sham).There are no multiple follow-up measurements planned — the timepoint is directly after intervention within the same session
    The primary outcome (endurance performance – time to exhaustion) is measured once in each experimental session, immediately after the application of the intervention (tDCS, tPCS, or sham). There is no multiple follow-up measurements planned — the timepoint is directly after intervention within the same session
    متغیر پیامد اولیه (عملکرد استقامتی – زمان طی مسافت ۱۵ کیلومتر در آزمون تایم‌تریل دوچرخه‌سواری) در هر جلسه آزمایشی، بلافاصله پس از اعمال مداخله (تحریک جریان مستقیم فراجمجمه‌ای، تحریک جریان پالسی فراجمجمه‌ای یا شرایط شم) اندازه‌گیری می‌شود.هیچ‌گونه اندازه‌گیری پیگیری در زمان‌های بعدی پیش‌بینی نشده است و نقطه زمانی ارزیابی، صرفاً بلافاصله پس از مداخله در همان جلسه خواهد بود.
    متغیر پیامد اولیه (عملکرد استقامتی زمان رسیدن به واماندگی در آزمون تایم‌تریل دوچرخه‌سواری) در هر جلسه، بلافاصله پس از اعمال مداخله (تحریک جریان مستقیم فراجمجمه‌ای، تحریک جریان پالسی فراجمجمه‌ای یا شرایط شم) اندازه‌گیری می‌شود.هیچ‌گونه اندازه‌گیری پیگیری در زمان‌های بعدی پیش‌بینی نشده است و نقطه زمانی ارزیابی، صرفاً بلافاصله پس از مداخله در همان جلسه خواهد بود.
    The primary outcome variable, endurance performance, will be measured using a 15 km time-trial cycling test on a Cycloergometer. Participants will be instructed to complete the distance in the shortest possible time while freely choosing their pedaling cadence. The time taken to complete the 15 km will be recorded as the endurance performance measure
    The primary outcome variable, namely endurance performance, will be assessed using a cycling test time to exhaustion on a cycle ergometer (Cyclus). During the initial session, participants’ peak power output will be determined by performing an incremental exercise test. In the three main experimental sessions, participants will be required to cycle at 85% of their determined peak power output until exhaustion, and the time to exhaustion will be recorded as the indicator of endurance performance.
    متغیر پیامد اولیه، یعنی عملکرد استقامتی، از طریق آزمون تایم‌تریل دوچرخه‌سواری به مسافت ۱۵ کیلومتر بر روی دوچرخه کارسنج (سایکلوس) اندازه‌گیری خواهد شد. از شرکت‌کنندگان خواسته می‌شود مسافت تعیین‌شده را در کوتاه‌ترین زمان ممکن طی کرده و ریتم رکاب‌زدن خود را به‌صورت آزاد انتخاب کنند. زمان صرف‌شده برای تکمیل مسافت ۱۵ کیلومتر به‌عنوان شاخص عملکرد استقامتی ثبت خواهد شد.
    متغیر پیامد اولیه، یعنی عملکرد استقامتی، از طریق آزمون رکابزنی تا زمان رسیدن به واماندگی بر روی دوچرخه کارسنج (سایکلوس) اندازه‌گیری خواهد شد. در جلسه ابتدائی با تعیین حداکثر توان بروده آزمودنی‌ها با اجرای تست فزاینده و اعمال 85 درصد آن مقدار در 3 جلسه‌ی اصلی، از شرکت‌کنندگان خواسته می‌شود تا رسیدن به واماندگی رکاب بزنند که زمان رسیدن به واماندگی به‌عنوان شاخص عملکرد استقامتی ثبت خواهد شد.
  • Recruitment centers

    #1
    Name of recruitment center - English: Exercise Metabolism and Performance Laboratory, Faculty of Sport Sciences, Razi University
    Name of recruitment center - Persian: آزمایشگاه متابولیسم و عملکرد ورزشی دانشکده علوم ورزشی دانشگاه رازی
    Full name of responsible person - English: Fereidoon Mouloodpoor
    Full name of responsible person - Persian: فریدون مولودپور
    Street address - English: Razi University, Bagh Abrisham blvd
    Street address - Persian: بلوار باغ ابریشم، دانشگاه رازی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714414971
    Phone: +98 918 776 4811
    Fax:
    Email: f.mouloodpoor@outlook.com
    Web page address:
    Name of recruitment center - English: Exercise Metabolism and Performance Laboratory, Faculty of Sport Sciences, Razi University
    Name of recruitment center - Persian: آزمایشگاه متابولیسم و عملکرد ورزشی دانشکده علوم ورزشی دانشگاه رازی
    Full name of responsible person - English: Fereidoon Mouloodpoor
    Full name of responsible person - Persian: فریدون مولودپور
    Street address - English: Razi University, Bagh Abrisham blvd
    Street address - Persian: بلوار باغ ابریشم، دانشگاه رازی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714414971
    Phone: +98 918 776 4811
    Fax:
    Email: f.mouloodpoor@yahoo.com
    Web page address:
  • Sponsors / Funding sources

    #1

    Name of organization / entity - English:
    Name of organization / entity - Persian:
    Full name of responsible person - English: Vahid Tadibi
    Full name of responsible person - Persian: وحید تادیبی
    Street address - English: Razi University, Bagh Abrisham blvd
    Street address - Persian: بلوار باغ ابریشم، دانشگاه رازی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714414971
    Phone: +98 918 132 1796
    Fax:
    Email: vtadibi@yahoo.com
    Web page address:
    contact.organization_id:
    Name of organization / entity - English: Razi University
    Name of organization / entity - Persian: دانشگاه رازی
    Full name of responsible person - English: Alireza Zebarjadi
    Full name of responsible person - Persian: دکتر علیرضا زبرجدی
    Street address - English: Razi University, Bagh Abrisham blvd
    Street address - Persian: بلوار باغ ابریشم، دانشگاه رازی
    City - English: Kermanshah
    City - Persian: کرمانشاه
    Province: Kermanshah
    Country: Iran (Islamic Republic of)
    Postal code: 6714414971
    Phone: +98 83 3427 4515
    Fax:
    Email: zebarjadiali@yahoo.com
    Web page address:

Protocol summary

Study aim
The study aims to compare the effects of tDCS and tPCS on endurance performance, Stroop color-word test results, choice reaction time, perceived exertion, pleasure, arousal level, pain perception, and the countdown task during endurance exercise in physical education students.
Design
This study uses a within-subject (crossover) design with randomization of experimental conditions, conducted double-blind with sham control. The order of exposure to the three conditions will be randomized using a Latin square method via www.random.org. A total of 15 participants will be recruited as the appropriate sample size for this study.
Settings and conduct
Participants will complete Stroop and choice reaction time tests before and after receiving electrical stimulation and performing an exhaustive cycling task. A one-minute countdown task will be administered at RPE 15. Perceptual–physiological variables (pain, pleasure, arousal, RPE, and heart rate) will be assessed every three minutes during exercise.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: Age 18–29 years; male physical education students at Razi University, third semester or higher; body mass index (BMI) 18.5–24.9 kg/m²; right-handed. Exclusion Criteria: Presence of any cardiovascular, pulmonary, or metabolic disease; history of seizures, epilepsy, or other neurological disorders; presence of implanted medical devices or pacemakers; use of tobacco or alcohol; color blindness or other visual impairments.
Intervention groups
Group 1: Received tDCS stimulation in the DLPFC region; Group 2: Received tPCS stimulation in the DLPFC region; Group 3 (or placebo group): Received sham stimulation.
Main outcome variables
Endurance performance, Stroop test, reaction time, countdown task, heart rate, rating of perceived exertion, pleasure, and arousal.

General information

Reason for update
The endurance testing protocol was modified from a 15-kilometer time-trial to a cycling endurance time to exhaustion test.
Acronym
IRCT registration information
IRCT registration number: IRCT20250812066842N1
Registration date: 2025-08-16, 1404/05/25
Registration timing: prospective

Last update: 2026-02-08, 1404/11/19
Update count: 1
Registration date
2025-08-16, 1404/05/25
Registrant information
Name
Fereidoon Mouloodpoor
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 83 3427 7609
Email address
f.mouloodpoor@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-09-23, 1404/07/01
Expected recruitment end date
2025-11-21, 1404/08/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the Effects of Transcranial Direct and Pulsed Current Stimulation on Endurance and Cognitive Performance in Physical Education Students
Public title
Non-invasive brain stimulation and Endurance function
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
Age range: 18–29 years Male physical education students at Razi University, third semester or higher Body mass index (BMI): 18.5–24.9 kg/m² Right-handed
Exclusion criteria:
Presence of any cardiovascular, pulmonary, or metabolic disease History of seizures, epilepsy, or other neurological disorders Presence of implanted medical devices or pacemakers Use of tobacco or alcohol Color blindness or other visual impairments
Age
From 18 years old to 29 years old
Gender
Male
Phase
N/A
Groups that have been masked
  • Participant
  • Investigator
Sample size
Target sample size: 15
More than 1 sample in each individual
Number of samples in each individual: 3
In each individual, the following samples/measurements are collected once per condition (tDCS, tPCS, sham), resulting in three sets per participant: Primary outcome 1. Endurance performance: time to exhaustion test on a cycloergometer. 2. Cognitive performance measures: Stroop Color-Word Test results (color, word, and color-word interference scores), reaction time in the choice reaction time test, and countdown task performance (correct responses and accuracy). 3. Physiological and perceptual measures (taken during and/or immediately after exercise): Heart rate, Rating of perceived exertion (RPE), Pleasure rating, Arousal level, Pain perception. Each participant completes all measurements under all three stimulation conditions, with at least 48 hours washout between sessions.
Randomization (investigator's opinion)
Randomized
Randomization description
To randomize the order in which participants are exposed to the three conditions in this study, a Latin square design will be employed. For this purpose, each participant will first be assigned a unique identification number between 1 and 15 using the website www.random.org. Next, the letters B, A, and C will be assigned to the three intervention conditions, and a Latin square will be constructed. In this configuration, a Latin square with three rows and three columns will be created. Finally, participants numbered 1 to 5 will follow the sequence in the first row, participants numbered 6 to 10 will follow the sequence in the second row, and participants numbered 11 to 15 will follow the sequence in the third row.
Blinding (investigator's opinion)
Double blinded
Blinding description
Both the participants and the principal investigator will be blinded to the type of stimulation received in each session. This information will remain accessible only to an individual outside the research team until the completion of the study. To maintain blinding of the stimulation order from the principal investigator, all procedures related to the random assignment of stimulation sequences for each participant will be conducted by this external individual. Additionally, to blind participants to the type of stimulation in each session, the tDCS device will be concealed from view using a cover, and the principal investigator will not be present in the laboratory during electrode placement, throughout the 20-minute stimulation period, or during electrode removal.
Placebo
Used
Assignment
Crossover
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Razi University
Street address
Razi University, Bagh Abrisham blvd,
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Approval date
2025-07-02, 1404/04/11
Ethics committee reference number
IR.RAZI.REC.1404.019

Health conditions studied

1

Description of health condition studied
This study involves healthy male physical education students aged 18–29 years with no cardiovascular, pulmonary, metabolic, neurological, musculoskeletal, or visual disorders. The research does not study a specific disease but examines neuromodulation effects on endurance and cognitive performance in a healthy, physically active population.
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The primary outcome variable is the endurance performance, specifically measured as the time to exhaustion on ergometer cycling test. This is the main variable expected to change as a result of the interventions (tDCS, tPCS, or sham), and it is the outcome used for calculating the sample size.
Timepoint
The primary outcome (endurance performance – time to exhaustion) is measured once in each experimental session, immediately after the application of the intervention (tDCS, tPCS, or sham). There is no multiple follow-up measurements planned — the timepoint is directly after intervention within the same session
Method of measurement
The primary outcome variable, namely endurance performance, will be assessed using a cycling test time to exhaustion on a cycle ergometer (Cyclus). During the initial session, participants’ peak power output will be determined by performing an incremental exercise test. In the three main experimental sessions, participants will be required to cycle at 85% of their determined peak power output until exhaustion, and the time to exhaustion will be recorded as the indicator of endurance performance.

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group 1: Participants will receive anodal transcranial direct current stimulation (tDCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the anode at F3 and the cathode at AF4, at 2 mA intensity for 20 minutes.
Category
Treatment - Devices

2

Description
Intervention group 2: Participants will receive anodal transcranial pulsed current stimulation (tPCS) over the left dorsolateral prefrontal cortex (L-DLPFC) with the same electrode placement, at 1.5 mA intensity for 20 minutes.
Category
Treatment - Devices

3

Description
Control group: Participants will receive sham stimulation with identical electrode placement; however, current will be delivered for only the first 30 seconds and then stopped, mimicking the sensation without providing actual stimulation.
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Exercise Metabolism and Performance Laboratory, Faculty of Sport Sciences, Razi University
Full name of responsible person
Fereidoon Mouloodpoor
Street address
Razi University, Bagh Abrisham blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 918 776 4811
Email
f.mouloodpoor@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Razi University
Full name of responsible person
Alireza Zebarjadi
Street address
Razi University, Bagh Abrisham blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
+98 83 3427 4515
Email
zebarjadiali@yahoo.com
Grant name
Razi University
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Razi University
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
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Razi University, Bagh Abrisham blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3427 7609
Email
vtadibi@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Razi University
Full name of responsible person
Vahid Tadibi
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Physiology
Street address
Razi University, Bagh Abrisham blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714414874
Phone
+98 83 3427 7609
Email
vtadibi@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Razi University
Full name of responsible person
Fereidoon Mouloodpoor
Position
Student
Latest degree
Master
Other areas of specialty/work
Physiology
Street address
Razi University, Bagh Abrisham blvd
City
Kermanshah
Province
Kermanshah
Postal code
6714414971
Phone
009883342776056
Email
f.mouloodpoor@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Not applicable
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
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