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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06389747
Other study ID # OU
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date April 24, 2024
Est. completion date June 15, 2024

Study information

Verified date April 2024
Source Istanbul University - Cerrahpasa (IUC)
Contact Gamze Aydin, PhD
Phone +905377600256
Email gmzetsn@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of our study is to determine and evaluate the effects of blood flow restriction technique on pain, biomechanical properties and strength of the muscle in delayed onset muscle pain in healthy individuals. A Double Blind, Randomized Controlled, prospective study was planned.


Description:

All participants will be taken into the DOMS creation protocol. Participants will then be divided into 80% intensity BFR and 20% intensity Blood Flow Restriction technique (BFR) groups and will be included in an exercise protocol accompanied by BFR application.


Recruitment information / eligibility

Status Recruiting
Enrollment 15
Est. completion date June 15, 2024
Est. primary completion date May 28, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 35 Years
Eligibility Inclusion Criteria: - Healthy individuals between the ages of 18-35 (who have not participated in any resistance training program for at least 6 months) Exclusion Criteria: - Having a previous musculoskeletal system injury - Having a condition that prevents resistance exercise - Having cardiovascular disease - Using medication for blood pressure control

Study Design


Related Conditions & MeSH terms


Intervention

Other:
BFR technique
For BFR application, Airbands brand, wireless, automatic training cuffs will be used. During application, it will be ensured that the device module faces forward and the cuff will be fixed in the correct position by wrapping the band around the metal ring. There will be a space between the skin and the cuff that can fit two fingers. The cuff will then be paired via Bluetooth with the Airbands app installed on the phone. BFR cuffs will be placed proximal to the biceps brachii muscle and pressure will be applied. The cuff will be inflated to automatically detect limb pressure. BFR application with 80% pressure to one group of participants and 20% pressure to the other group will be applied simultaneously with the exercise.

Locations

Country Name City State
Turkey Gamze Aydin Istanbul
Turkey Istanbul Okan University Istanbul

Sponsors (1)

Lead Sponsor Collaborator
Istanbul University - Cerrahpasa (IUC)

Country where clinical trial is conducted

Turkey, 

Outcome

Type Measure Description Time frame Safety issue
Primary Visual analog scale it will be used for assessment of pain intensity, It is scored between 0-10, and higher scores indicate that the situation is getting worse. 2 months
Primary myoton it will be used for assessment of muscle tonus and biomechanic properties, scores are changin according to different parameters. 2 months
Primary dynamometer it will be used for assessment of myscle strength, lower scores indicate that the situation is getting worse. 2 months
Primary dolorimeter it will be used for assessment of pain thresold pressure, lower scores indicate that the situation is getting worse. 2 months
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