NCT07130812

Brief Summary

The purpose of this graduate student research study is to compare the effects of low-load blood flow restriction training (LL-BFR) and heavy-load training (HLT) in high-volume rowers with mild low back pain or recurrent low back pain (LBP), aiming to determine whether LL-BFR offers a safer yet equally effective alternative to HLT for enhancing performance and reducing risk of re-injury.

Trial Health

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Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for not_applicable low-back-pain

Timeline
Completed

Started Sep 2025

Shorter than P25 for not_applicable low-back-pain

Geographic Reach
1 country

1 active site

Status
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

First Submitted

Initial submission to the registry

August 13, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 19, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

September 29, 2025

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

October 6, 2025

Status Verified

August 1, 2025

Enrollment Period

6 months

First QC Date

August 13, 2025

Last Update Submit

September 30, 2025

Conditions

Keywords

blood flow restriction

Outcome Measures

Primary Outcomes (1)

  • Hamstring and quadricep muscular fatigue assessment via Noraxon Electromyography

    change between baseline and 10 weeks

Study Arms (2)

Blood Flow Restriction Group

ACTIVE COMPARATOR

Using blood flow restriction, participants partake in aerobic (rowing) and anaerobic (squats/deadlifts) exercises.

Other: blood flow restriction

Non Blood Flow Restriction Group

ACTIVE COMPARATOR

Participants partake in aerobic and anaerobic exercises without blood flow restrictions. The participants will use heavier loads in the anaerobic exercises.

Other: Heavy load resistance training

Interventions

The SAGA blood flow restriction tourniquet system will be used for each training sessions for the rowers within the light load restriction group. The 4 inch-wide tourniquet will be applied to both upper thighs during the strength and endurance exercises. Tourniquet setting will be determined as the pressure needed to achieve 40-80% arterial occlusion to the extremity (as measured by the SAGA BFR unit). The SAGA units provides a consistent amount of pressure to the extremity throughout the ROM of the exercise. The settings will be determined at baseline and then recalibrated weekly.

Blood Flow Restriction Group

For the resistance prescription, rowers will do strengthening exercises at 70-80% 1 RM. Exercises will be performed in series following 6 sets by 5 reps, with 120 seconds of rest between sets for each exercise.

Non Blood Flow Restriction Group

Eligibility Criteria

Age13 Years - 20 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Aged 13-20 years old
  • Currently active rower (training ≥3 days/week or 12 hours/week)
  • Mild LBP with a low reactivity (\<3/10) or recurring LBP within the past 18 months that has affected attendance to team practices/races.
  • Able to complete a 2,000-meter rowing erg test

You may not qualify if:

  • Have severe or acute back pain that limits basic movement or requires medical treatment
  • History of spinal surgery or structural spine conditions (scoliosis requiring bracing/surgery)
  • Have a contraindication to BFR training, identified via BFR safety screening form:
  • Peripheral vascular disease (PVD)
  • History of vascular surgery in arms or legs
  • Skin grafts on arms or legs
  • Arteriovenous fistula in limbs
  • Cognitive or physical impairment that limits participation
  • Hypertension or high blood pressure (uncontrolled or undiagnosed)
  • Bleeding disorders (e.g., hemophilia)
  • Blood clotting disorders (e.g., lupus, factor-V Leiden)
  • Past history of DVT or pulmonary embolism (PE)
  • Surgery in the past 12 weeks
  • Recent limb immobilization (e.g., cast, boot) in the last 4 weeks
  • History of stroke or transient ischemic attack (TIA)
  • +10 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Loma Linda University

Loma Linda, California, 92350, United States

RECRUITING

MeSH Terms

Conditions

Low Back Pain

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy Modalities

Study Officials

  • Everett Lohman, Dsc

    Loma Linda University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Everett Lohman, DSc

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 13, 2025

First Posted

August 19, 2025

Study Start

September 29, 2025

Primary Completion

April 1, 2026

Study Completion

April 1, 2026

Last Updated

October 6, 2025

Record last verified: 2025-08

Locations