NCT07561281

Brief Summary

This study aimed to compare the effects of low-load blood flow restriction resistance exercise (BFR-RE) performed to voluntary failure with traditional high-load resistance exercise (HL-RE) and a control condition on biceps brachii muscle hypertrophy, muscle stiffness, and maximal strength in untrained young men. Participants completed an 8-week training program, with exercise performed three times per week. Outcomes were assessed using ultrasound imaging, elastography, and one-repetition maximum (1RM) testing. The study evaluates whether low-load BFR training can produce adaptations comparable to high-load resistance training.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2025

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 3, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 3, 2025

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

April 24, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

May 1, 2026

Completed
Last Updated

May 7, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

April 24, 2026

Last Update Submit

May 2, 2026

Conditions

Keywords

Blood Flow Restriction

Outcome Measures

Primary Outcomes (1)

  • Biceps Brachii Muscle Thickness

    Muscle thickness of the biceps brachii was assessed using ultrasound imaging to evaluate hypertrophic adaptations following the intervention.

    Baseline and 8 weeks (post-intervention), with an additional follow-up measurement at 1 week after the intervention

Study Arms (3)

BFR-RE

EXPERIMENTAL

Participants performed low-load resistance exercise with blood flow restriction using 30% of one-repetition maximum (1RM) and 60% limb occlusion pressure. Exercises were performed to voluntary failure, three times per week for 8 weeks.

Device: Blood Flow Restriction Resistance Exercise

HL-RE

ACTIVE COMPARATOR

Participants performed traditional high-load resistance exercise at 70% of one-repetition maximum (1RM) without blood flow restriction, three times per week for 8 weeks.

Behavioral: High-Load Resistance Exercise

Control

NO INTERVENTION

Participants did not engage in any structured resistance training program and continued their normal daily activities throughout the 8-week study period.

Interventions

Resistance exercise was performed under partial vascular occlusion using a pneumatic cuff applied to the upper arm. Limb occlusion pressure was individually determined, and exercise was conducted at a relative intensity corresponding to a percentage of one-repetition maximum. Occlusion pressure was maintained during sets and released between exercises. Training load and repetition tempo were standardized and progressively adjusted throughout the intervention period.

Also known as: BFR Training
BFR-RE

Participants performed resistance exercise using conventional loading strategies based on a percentage of one-repetition maximum. Training intensity, volume, and progression were standardized across sessions, with loads adjusted periodically according to performance assessments.

Also known as: Traditional Resistance Training
HL-RE

Eligibility Criteria

Age18 Years - 30 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy male participants aged 18-30 years No prior history of structured or specialized resistance training targeting the biceps brachii muscle Normotensive (blood pressure \<140/90 mmHg) Right-handed (to reduce variability related to limb dominance) Willing to provide written informed consent and comply with the study protocol

You may not qualify if:

  • History of orthopedic injury or musculoskeletal disorder affecting the upper extremities Diagnosis of hypertension (≥140/90 mmHg) or cardiovascular disease Any neurological condition affecting motor performance Current participation in any structured resistance training program Use of medications or supplements known to influence muscle metabolism or performance

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabük University Hasan Dogan Faculty of Sport Sciences

Karabük, Karabük Province, 78050, Turkey (Türkiye)

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
This study employed a single-blind design in which outcome assessors were blinded to group assignment while participants care providers and investigators were not blinded due to the nature of the exercise intervention.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participants were assigned to one of three parallel groups: blood flow restriction training group low load resistance training group and control group and all outcomes were assessed pre and post intervention.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 24, 2026

First Posted

May 1, 2026

Study Start

June 1, 2025

Primary Completion

August 3, 2025

Study Completion

August 3, 2025

Last Updated

May 7, 2026

Record last verified: 2026-05

Locations