- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06389747
Effect of Blood Flow Restriction Technique on Delayed Onset Muscle Soreness
April 28, 2024 updated by: Gamze Aydin, Istanbul University - Cerrahpasa (IUC)
Effect of Blood Flow Restriction Technique on Pain, Muscle Tone and Strength in Delayed Muscle Soreness
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.
Study Overview
Detailed 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.
Study Type
Interventional
Enrollment (Estimated)
15
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Gamze Aydın, PhD
- Phone Number: +905377600256
- Email: gmzetsn@gmail.com
Study Locations
-
-
-
Istanbul, Turkey, 34940
- Recruiting
- Gamze Aydın
-
Contact:
- Gamze Aydın
- Email: gmzetsn@gmail.com
-
Istanbul, Turkey, 34944
- Recruiting
- Istanbul Okan University
-
Contact:
- Gamze Aydın, PhD
- Phone Number: +905377600256
- Email: gmzetsn@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Yes
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: %80 BFR group
%80 intensity BFR technique will be applied to this group.
|
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.
|
Active Comparator: %20 BFR group
%20 intensity BFR technique will be applied to this group.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Visual analog scale
Time Frame: 2 months
|
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
|
myoton
Time Frame: 2 months
|
it will be used for assessment of muscle tonus and biomechanic properties, scores are changin according to different parameters.
|
2 months
|
dynamometer
Time Frame: 2 months
|
it will be used for assessment of myscle strength, lower scores indicate that the situation is getting worse.
|
2 months
|
dolorimeter
Time Frame: 2 months
|
it will be used for assessment of pain thresold pressure, lower scores indicate that the situation is getting worse.
|
2 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 24, 2024
Primary Completion (Estimated)
May 28, 2024
Study Completion (Estimated)
June 15, 2024
Study Registration Dates
First Submitted
April 25, 2024
First Submitted That Met QC Criteria
April 25, 2024
First Posted (Actual)
April 29, 2024
Study Record Updates
Last Update Posted (Actual)
April 30, 2024
Last Update Submitted That Met QC Criteria
April 28, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- OU
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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