NCT07848048

Brief Summary

This randomized controlled trial investigated the acute musculoskeletal responses to isometric exercise with and without blood flow restriction in healthy, physically active young adults. Participants were randomly assigned to one of three groups: high-intensity isometric exercise (HI), low-intensity isometric exercise with blood flow restriction (LI-BFR), or low-intensity isometric exercise with sham blood flow restriction (LI-Sham). Ultrasound measurements of patellar tendon and vastus medialis muscle thickness were obtained before and immediately after the exercise intervention. Knee-extension maximal voluntary isometric contraction was also assessed. The study aimed to compare the acute changes in these outcomes among the three exercise conditions.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 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

October 13, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 24, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 24, 2026

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

September 22, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 29, 2026

Completed
Last Updated

September 29, 2026

Status Verified

September 1, 2026

Enrollment Period

6 months

First QC Date

September 22, 2026

Last Update Submit

September 22, 2026

Conditions

Keywords

low-intensity resistance exerciseRehabilitationVascular occlusionTendon morphologyIsometric contractionUltrasonography

Outcome Measures

Primary Outcomes (1)

  • Change in Patellar Tendon Thickness

    Patellar tendon thickness was assessed by B-mode ultrasonography at 25%, 50%, and 75% of the tendon length, from the inferior pole of the patella to the tibial tuberosity.

    Baseline and immediately post-intervention

Secondary Outcomes (2)

  • Change in Vastus Medialis Muscle Thickness

    Baseline and immediately post-intervention

  • Change in Knee-Extension Maximal Voluntary Isometric Contraction (MVIC)

    Baseline and immediately post-intervention

Study Arms (3)

High-Intensity Isometric Exercise (HI)

EXPERIMENTAL

Participants performed five 30-second isometric knee-extension contractions at 70% of maximal voluntary isometric contraction (MVIC), with 60 seconds of rest between sets.

Behavioral: High-Intensity Isometric Exercise

Low-Intensity Isometric Exercise With Blood Flow Restriction (LI-BFR)

EXPERIMENTAL

Participants performed five 30-second isometric knee-extension contractions at 30% of MVIC with a pneumatic cuff inflated to 80% of the individual arterial occlusion pressure (AOP) during each contraction. The cuff was deflated during the 60-second rest periods between sets.

Behavioral: Low-Intensity Isometric Exercise With Blood Flow Restriction

Low-Intensity Isometric Exercise With Sham Blood Flow Restriction (LI-Sham)

EXPERIMENTAL

Participants performed five 30-second isometric knee-extension contractions at 30% of MVIC with a pneumatic cuff inflated to 20 mmHg during each contraction. The cuff was deflated during the 60-second rest periods between sets.

Behavioral: Low-Intensity Isometric Exercise With Sham Blood Flow Restriction

Interventions

Participants performed five 30-second isometric knee-extension contractions at 30% of MVIC with a pneumatic cuff inflated to 80% of the individual arterial occlusion pressure (AOP) during each contraction. The cuff was deflated during the 60-second rest periods between sets.

Low-Intensity Isometric Exercise With Blood Flow Restriction (LI-BFR)

Participants performed five 30-second isometric knee-extension contractions at 30% of MVIC with a pneumatic cuff inflated to 20 mmHg during each contraction. The cuff was deflated during the 60-second rest periods between sets.

Low-Intensity Isometric Exercise With Sham Blood Flow Restriction (LI-Sham)

Participants performed five 30-second isometric knee-extension contractions at 70% of maximal voluntary isometric contraction (MVIC), with 60 seconds of rest between sets.

High-Intensity Isometric Exercise (HI)

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • \- Healthy men and women aged 18-40 years.

You may not qualify if:

  • Current musculoskeletal injury.
  • Cardiovascular disease.
  • Inability to complete the study protocol.
  • Diagnosis of patellar tendinopathy within the previous 6 months.
  • Contraindications to blood flow restriction, including pregnancy, thrombosis, excessive varicose veins, or a prosthesis in the region to be occluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Valencia

Valencia, Valencia, 46010, Spain

Location

Study Officials

  • Yasser Alakhdar Mohmara

    University of Valencia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Principal Investigator

Study Record Dates

First Submitted

September 22, 2026

First Posted

September 29, 2026

Study Start

October 13, 2025

Primary Completion

April 24, 2026

Study Completion

April 24, 2026

Last Updated

September 29, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

Locations