NCT06746792

Brief Summary

Low-load resistance exercise with blood flow restriction (BFR-RE) presents a compelling alternative to high-load resistance exercise (HL-RE), particularly in scenarios where high loads are not feasible due to various limitations. Blood flow restriction exercise restricts blood flow to the working muscle, creating a state of ischemia. A significant advantage of BFR-RE lies in its capacity to stimulate muscle hypertrophy and strength adaptations using light external loads (20-30% 1RM), comparable to those achieved with high-load (HL) training programs that employ 70-85% 1RM As a result, BFR training has been increasingly adopted in both athletic performance and rehabilitation settings over the past few decades. Quadriceps strength and power are essential factors in both the advancement of athletic performance and the successful return to unrestricted sporting activity following injury. The findings of Culvenor et al.'s review strongly suggest that weakened quadriceps strength is a significant risk factor for symptomatic and functional decline in the knee during both activities of daily living and sport-recreational activities. Numerous electromyographic (EMG) findings suggest that single-joint and multijoint exercises elicit varying muscle activation patterns. For instance, single-joint exercises targeting the quadriceps, such as leg extensions, demonstrate higher EMG amplitudes compared to multijoint lower-extremity exercises like leg presses and squats. Resistance training, characterized by the application of high mechanical tension, remains the cornerstone for promoting muscle hypertrophy, So, research suggests that higher training intensities are associated with greater hypertrophy, up to a certain point. While both light and heavy loads have been shown to elicit similar muscle growth when sets are taken to failure. Studies have reported that high-repetition training with light loads leads to greater central fatigue. Existing literature comparing the effects of BFR-RE and HL-RE primarily focuses on the some quadriceps and hamstring muscle group and its associated exercises. However, none of these studies employed a training protocol in which sets were taken to or near failure.

Trial Health

55
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
active not recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 11, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 11, 2024

Completed
13 days until next milestone

First Posted

Study publicly available on registry

December 24, 2024

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 29, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 29, 2025

Completed
Last Updated

March 4, 2025

Status Verified

March 1, 2025

Enrollment Period

6 months

First QC Date

December 11, 2024

Last Update Submit

March 3, 2025

Conditions

Keywords

vascular occlusionshear wave elastographyhypertrophymuscle stiffnessstrength

Outcome Measures

Primary Outcomes (4)

  • Thigh Circumference

    Measurement of thigh circumference was performed at a point 33% distal to the inguinal crease, precisely matching the intended cuff application site as verified by a trained investigator. The inguinal crease-to-superior patellar pole distance was also recorded using a standard anthropometric tape measure

    2 day

  • Muscle Strength Test

    Prior to commencing the strength assessment, using a Lafayette Manual Muscle Testing System (Lafayette Instrument Company, Lafayette®) a period of familiarization was allowed between the examiner and participant. Subsequently, a trained examiner guided the participant through a series of practice repetitions of leg flexion, and leg extension movements until correct execution was confirmed. The order of movements was randomized. The participant was then verbally instructed to perform three maximal contractions for each movement (3-second hold). A 1-minute rest interval was incorporated between successive contractions, and a 3-minute rest interval was implemented between different movement sets. Measurement of leg extension were obtained with participants in a seated position, while leg flexion measurement were taken with participants in a prone position.

    2 day

  • Muscle Thickness Assessment

    Subjects had not engaged in physical activity before the study (48-72 hours), and muscle thickness (MT) was measured at a prone rest position. All muscle thickness measurements were obtained with a single ultrasound device equipped with a 2-9 MHz linear transducer. A researcher (medical doctor, N.K.K) who was blinded to the exercise groups with more than 10 years of experience in musculoskeletal imaging performed all measurement

    4 day

  • Muscle Stiffness and Shear Wave Elastography

    After the muscle thickness measurements, the stiffness measurements of quadriceps muscle were obtained using the shear wave elastography (SWE) imaging option of the same ultrasound device with the same linear transducer.

    4 day

Other Outcomes (3)

  • Anthropometric Measurements

    One day

  • Blood Pressure

    One day

  • Heart Rate

    One day

Study Arms (2)

Muscle thickness

EXPERIMENTAL

Muscular hypertrophy , or muscle growth, refers to an increase in muscle mass. There are two types of muscular hypertrophy: myofibrillar, which is an increase in myofibrils, and sarcoplasmic, which is an increase in muscle glycogen storage.

Other: Low-load resistance exercise with blood flow restrictionOther: High-load resistance exercise

Muscle stiffness and strength

EXPERIMENTAL

Muscle and tendon stiffness is defined as an internal resistance to changes in muscle and tendon shape caused by an external force. Muscle strength production takes place with the help of the elastic behavior of the muscles and tendons

Other: Low-load resistance exercise with blood flow restrictionOther: High-load resistance exercise

Interventions

BFR-RE group performed bilateral leg extension exercises to volitional exhaustion (90 seconds rest between sets, 30% 1RM) with BFR cuffs applied at 60% of limb occlusion pressure.

Also known as: (BFR-RE)
Muscle stiffness and strengthMuscle thickness

The HL-RE group performed the same exercise to volitional exhaustion (90 seconds rest between sets, 70% 1RM) without BFR cuffs.

Also known as: (HL-RE)
Muscle stiffness and strengthMuscle thickness

Eligibility Criteria

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

You may qualify if:

  • keep healthy
  • must be able to attend training regularly

You may not qualify if:

  • smoking habit
  • had orthopedic conditions that hindered lower-body resistance exercise, had hypertension (140/90 mm Hg), or had a BMI exceeding 30 kg/m2

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University Faculty of Sports Sciences

Karabük, 78000, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

December 11, 2024

First Posted

December 24, 2024

Study Start

October 11, 2024

Primary Completion

March 29, 2025

Study Completion

March 29, 2025

Last Updated

March 4, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share

All antropometric and muscle strength, muscle thickness, and muscle stiffness parameters will be shared

Shared Documents
STUDY PROTOCOL, SAP, ICF, CSR

Locations