- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05274542
Acute Effect of Blood Flow Restricted High-Intensity Resistive Training
February 22, 2023 updated by: Gülsena Utku, Halic University
Acute Effect of Blood Flow Restricted High-Intensity Resistive Training on Rectus Femoris Muscle Activity, Reaction Time, Muscular Performance, and Fatigue Level
Recommended by many professional organizations such as the American College of Sports Medicine (ACSM) and the National Strength and Conditioning Association (NSCA), resistance exercise training improves muscle strength, body composition, performance, functionality and quality of life in healthy young adults.
Blood flow restriction (BFR), also known as Kaatsu training, is proposed as a new method to improve muscle strength and muscle hypertrophy in a short time.
Although there are studies in the literature in which BFR is applied with low-intensity resistance training, no studies have been found examining the effects of BFR applied with high-intensity resistance training on the neuromuscular adaptations of the quadriceps femoris muscle.
Determining whether high-intensity resistance training with BFR is more effective on the quadriceps femoris muscle compared to high-intensity resistance training applied without BFR may provide faster and more effective responses by arranging resistance training protocols in terms of neuromuscular gains.
Between 07.03.2022 and 07.06.2022, in the Biruni University Physiotherapy and Rehabilitation Department Application Laboratory, in which 24 healthy young adults between the ages of 18-25 (from 12 BFR, 12 BFR) will be included, exercise training to be applied with and without BFR was determined.
Its effects will be compared with electromyographic measurement, single leg squat test, and measurement of late-onset muscle pain (Visual Analog Scale).
IBM SPSS 21.0 statistical program will be used for statistical analysis.
Whether the variables are suitable for normal distribution will be analyzed with the Shapiro-Wilk test.
If the variables show normal distribution, the variation within the group will be analyzed with the paired samples t test, and if it does not show normal distribution, the Wilcoxon Signed rank test will be analyzed.
Comparison of groups will be made with independent samples t-test in independent groups if the variables show normal distribution, and with Mann Whitney-U test if they do not show normal distribution.
Categorical data distributions will be evaluated with the Chi-square test.
Study Overview
Status
Completed
Study Type
Interventional
Enrollment (Actual)
24
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 Locations
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Istanbul, Turkey
- Halic University
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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
18 years to 25 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Between the ages of 18-25
- Healthy
- Be volunteer to participate the study
Exclusion Criteria:
- Pregnancy
- Breastfeeding status
- Cardiovascular disease
- Musculoskeletal problems
- Orthopedic problems related to the lower extremities
- Peripheral or central neurological disorders
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: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: high intensity with blood flow restriction group
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Participants in high intensity with blood flow restriction group (n=12) will be given high-intensity resistance exercise training that restricts blood flow.
Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets.
The exercises will be performed in a single session accompanied by a physiotherapist.
A blood pressure cuff will be used to restrict blood flow.
By applying the cuff to the proximal of the muscle, the blood flow will be restricted with a pressure of 150 mmHg and the muscle will be exercised in this way.
After the exercise, the cuff will be removed and evaluations will be made after 2 minutes of rest.
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Active Comparator: high intensity without blood flow restriction group
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Participants in high intensity without blood flow restriction group (n=12) will be given high-intensity resistance exercise training.
Open kinetic chain rectus femoris resistance exercise training will be given with free weights, 80% of 1 RM with 8 repetitions, 2 sets and 3 minutes rest between sets.
The exercises will be performed in a single session accompanied by a physiotherapist.
After the exercise, after 2 minutes of rest, evaluations will be made.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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EMG measurement
Time Frame: immediately after intervention
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Electrodes in the RF muscle are placed in the middle of the muscle abdominals according to the recommendations of the Surface Electromyography for Non-Invasive Evaluation of Muscles club and the International Society of Electrophysiology and Kinesiology.
Data will be evaluated with the Neurotrac® Simplex (Verity Medical Ltd., Braishfield, UK) wireless EMG device.
The recording range in the device is between 0.2 µV - 2000 µV and has a 0.1 µV RMS sensitivity, 10 m free wireless (Bluetooth) connection range.
The signals coming from the electrodes will be automatically filtered and transferred to digital media via software.
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immediately after intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Hermens HJ, Freriks B, Disselhorst-Klug C, Rau G. Development of recommendations for SEMG sensors and sensor placement procedures. J Electromyogr Kinesiol. 2000 Oct;10(5):361-74. doi: 10.1016/s1050-6411(00)00027-4.
- Loenneke JP, Wilson JM, Marin PJ, Zourdos MC, Bemben MG. Low intensity blood flow restriction training: a meta-analysis. Eur J Appl Physiol. 2012 May;112(5):1849-59. doi: 10.1007/s00421-011-2167-x. Epub 2011 Sep 16.
Helpful Links
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)
March 7, 2022
Primary Completion (Actual)
July 7, 2022
Study Completion (Actual)
December 7, 2022
Study Registration Dates
First Submitted
February 19, 2022
First Submitted That Met QC Criteria
March 1, 2022
First Posted (Actual)
March 10, 2022
Study Record Updates
Last Update Posted (Estimate)
February 23, 2023
Last Update Submitted That Met QC Criteria
February 22, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Other Study ID Numbers
- HI-BFR training
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
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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