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IRCT20241205063953N2 IRCT 2025-02-09 Islamic Azad University Blood Flow Restriction Resistance Training, Follistatin, and IGF-1 The Effects of Resistance Training With and Without Blood Flow Restriction on Follistatin and IGF-1 Levels in Male Students 2025-01-29 anticipated 45 Complete https://irct.ir/trial/81260 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Other, Randomization description: Simple randomization will be used to allocate participants into three groups. A random number table will be utilized for this purpose. The random number table will be obtained from a standard source (such as statistical software or reference books on randomization). Each group will be assigned a code: Group 1 (traditional resistance training), Group 2 (resistance training with blood flow restriction), Group 3 (control). To generate the sequence, random numbers will be read from the table in order. Each number will be assigned sequentially to one of the three groups. The randomization sequence will be prepared confidentially and placed in sealed and numbered envelopes. The envelope numbers will correspond to the participant numbers (based on the order of entry into the study). The staff responsible for participant enrollment will not have access to the content of the envelopes or the group allocation sequence. Each participant, after being confirmed as eligible for the study, will receive a numbered envelope based on their order of entry (e.g., the first participant will receive envelope 1, the second participant envelope 2, and so on). The envelope number will indicate the group allocation for that participant. The randomization and allocation process will be conducted by an independent individual (unrelated to data analysis or intervention implementation) to ensure impartiality. All envelopes will remain sealed until the allocation process is complete. N/A Exercise. Intervention 1: Intervention group: Participants will train for eight weeks, three sessions per week. Training intensity will be set at 20-30% of one-repetition maximum (1RM), with specialized cuffs applied to the exercising limbs to partially restrict blood flow. Cuff pressure will be adjusted based on individual systolic blood pressure (120-160 mmHg) and increased by 10% every two weeks. Exercises include leg press, leg curl, biceps curl, triceps extension, and knee extension, performed in four sets each. Intervention 2: Intervention group: Participants will train for eight weeks, three sessions per week. Training intensity will be set at 70-80% of 1RM without any blood flow restriction. Exercises will be identical to Intervention Group 1, including leg press, leg curl, biceps curl, triceps extension, and knee extension, performed in four sets each. Intervention 3: Control group: Participants in this group will not receive any exercise intervention and will continue their regular daily activities. Yes - There is a plan to make this available What will be shared: Raw data related to the primary outcome variables (follistatin levels, IGF-1 levels, body fat percentage, and muscular strength) will be shared after anonymizing participants' personal information. The data will be provided in Excel files and will be accessible solely for research purposes. Access requests must be sent via email to the corresponding author and will be granted upon approval by the Research Ethics Committee of Islamic Azad University, Shahrekord Branch. When: Access to the data and documents will begin 6 months after the publication of results in a peer-reviewed scientific journal and will remain available for 2 years. To whom: The data and documents will only be accessible to researchers affiliated with academic and scientific institutions. Applicants must provide their institutional affiliation and specify their research purpose. Conditions: The data will be used solely for research and scientific analysis and cannot be used for commercial or personal purposes. Applicants must submit a research proposal, adhere to ethical research principles, and sign an agreement not to share the data. Access will be granted upon approval by the Research Ethics Committee of Islamic Azad University, Shahrekord Branch. Where to obtain: Applicants can send their requests to the corresponding author, Naser Alimardani, via email at Jafari.akm@gmail.com. For coordination and follow-up, they can also contact him at +98 9125479267. Postal address: Department of Physical Education, Islamic Azad University, Shahrekord Branch, Shahrekord, Chaharmahal and Bakhtiari, Iran. How to obtain: The applicant must email their research proposal, study objectives, and institutional affiliation to the corresponding author. After review and approval by the ethics committee, the applicant signs an ethical agreement, and the data is shared within 2 to 4 weeks via email or a secure platform. Comments:
public Akram Jafari
Rahmatieh, Islamic Azad University, Shahrekord Branch, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8817630003 0098383361001 jafari.akm@gmail.com Islamic Azad University scientific Akram Jafari
Rahmatieh, Islamic Azad University, Shahrekord Branch, Shahrekord, Iran
Shahrekord Iran (Islamic Republic of) 8817630003 0098383361001 jafari.akm@gmail.com Islamic Azad University Iran (Islamic Republic of) Male aged 20 to 25 years Body Mass Index (BMI) between 20 and 25 kg/m² No medical contraindications for resistance training with blood flow restriction No regular physical activity in the past six months General health confirmed by a physician, including cardiovascular and blood pressure assessment No use of specific medications or supplements affecting sports performance or hormones 20 years 25 years Male History of cardiovascular disease or uncontrolled hypertension Presence of chronic conditions such as diabetes, kidney, or liver failure Physical or musculoskeletal limitations preventing resistance training Use of medications affecting hormones or metabolism Consumption of sports supplements or anabolic steroids Recent injury or surgery affecting physical performance Z00.3 Encounter for examination for adolescent development state N/A N/A N/A Intervention group: Participants will train for eight weeks, three sessions per week. Training intensity will be set at 20-30% of one-repetition maximum (1RM), with specialized cuffs applied to the exercising limbs to partially restrict blood flow. Cuff pressure will be adjusted based on individual systolic blood pressure (120-160 mmHg) and increased by 10% every two weeks. Exercises include leg press, leg curl, biceps curl, triceps extension, and knee extension, performed in four sets each. Intervention group: Participants will train for eight weeks, three sessions per week. Training intensity will be set at 70-80% of 1RM without any blood flow restriction. Exercises will be identical to Intervention Group 1, including leg press, leg curl, biceps curl, triceps extension, and knee extension, performed in four sets each Control group: Participants in this group will not receive any exercise intervention and will continue their regular daily activities. Follistatin. Timepoint: It will be measured 48 hours before the start and 48 hours after the end of the intervention. Method of measurement: Measured using the enzyme-linked immunosorbent assay (ELISA) method with kits from R&D Systems, USA. IGF-1 levels. Timepoint: It will be measured 48 hours before the start and 48 hours after the end of the intervention. Method of measurement: Measured using the ELISA method with kits from Mediagnost, Germany. Body fat percentage. Timepoint: It will be measured 48 hours before the start and 48 hours after the end of the intervention. Method of measurement: Measured using a bioelectrical impedance analysis device, Olympia 3.3, manufactured in South Korea. Muscular strength (leg press and bench press). Timepoint: It will be measured 48 hours before the start and 48 hours after the end of the intervention. Method of measurement: Assessed through the one-repetition maximum (1RM) test and calculated using the Brzycki formula. Islamic Azad University Approved 2025-01-09 Research Ethics Committee of Islamic Azad University, Shahrekord Branch Islamic Azad University, Rahmatieh, Shahrekord Branch, Shahrekord, Iran Shahrekord Chahar-Mahal-va-Bakhtiari Iran (Islamic Republic of)