NCT05274542

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 19, 2022

Completed
16 days until next milestone

Study Start

First participant enrolled

March 7, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 10, 2022

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 7, 2022

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 7, 2022

Completed
Last Updated

February 23, 2023

Status Verified

February 1, 2023

Enrollment Period

4 months

First QC Date

February 19, 2022

Last Update Submit

February 22, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • EMG measurement

    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.

    immediately after intervention

Study Arms (2)

high intensity with blood flow restriction group

EXPERIMENTAL
Other: high intensity with blood flow restriction

high intensity without blood flow restriction group

ACTIVE COMPARATOR
Other: high intensity without blood flow restriction group

Interventions

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.

high intensity with blood flow restriction group

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.

high intensity without blood flow restriction group

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Between the ages of 18-25
  • Healthy
  • Be volunteer to participate the study

You may not qualify if:

  • Pregnancy
  • Breastfeeding status
  • Cardiovascular disease
  • Musculoskeletal problems
  • Orthopedic problems related to the lower extremities
  • Peripheral or central neurological disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Haliç University

Istanbul, Turkey (Türkiye)

Location

Related Publications (3)

  • 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.

    PMID: 11018445BACKGROUND
  • 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.

    PMID: 21922259BACKGROUND
  • Korkmaz Dayican D, Ulker Eksi B, Yigit S, Utku Umut G, Ozyurek B, Yilmaz HE, Akinci B. Immediate Effects of High-Intensity Blood Flow Restriction Training on Muscle Performance and Muscle Soreness. Res Q Exerc Sport. 2025 Mar;96(1):213-222. doi: 10.1080/02701367.2024.2389902. Epub 2024 Aug 26.

Related Links

Study Officials

  • Gülsena Utku Umut

    Halic University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 19, 2022

First Posted

March 10, 2022

Study Start

March 7, 2022

Primary Completion

July 7, 2022

Study Completion

December 7, 2022

Last Updated

February 23, 2023

Record last verified: 2023-02

Locations