NCT04285879

Blood Flow Restriction Training (BFR) in an Adolescent Population

Completed NA Results posted Last updated 17 July 2024

What this trial tests

NA trial testing Blood Flow Restriction using Delfi Personalized Tourniquet System in Blood Flow Restriction in 47 participants. Completed in 16 October 2023.

Timeline

15 December 2020

Primary endpoint
15 January 2023

16 October 2023

Quick facts

Lead sponsor	Connecticut Children's Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	47
Start date	15 December 2020
Primary completion	15 January 2023
Estimated completion	16 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Blood Flow Restriction using Delfi Personalized Tourniquet System

Conditions studied

• Blood Flow Restriction — all drugs for Blood Flow Restriction →
• ACL Tear — all drugs for ACL Tear →
• ACL Injury — all drugs for ACL Injury →

Sponsor

Connecticut Children's Medical Center

Who can join

Adults 12 to 18, any sex, with Blood Flow Restriction or ACL Tear. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Isometric Quad Strength Peak Torque Primary · 3 month and return to sport post-operative strength (6-8 months post-op)

Isometric strength testing to measure peak torque quadriceps strength (unit: nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

3 month isometric

Group	Value	95% CI
BFR Exercise Group	1.83	± .35
Non-BFR Exercise Group	1.31	± 0.63

return to sport isometric (between approximately 6-8 months post-op)

Group	Value	95% CI
BFR Exercise Group	2.45	± 0.64
Non-BFR Exercise Group	2.1	± 0.6

Isometric Quad Strength Limb Symmetry Index Primary · 3 month and return to sport isometric quad strength limb symmetry

Quadriceps limb symmetry index is calculated by taking the values from outcome 1. \[ ( peak torque quadriceps involved limb (nm-kg)/ peak torque quadriceps uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage. 100% would equal perfect symmetry. Should involve limb demonstrate greater strength then uninvolved limb symmetry scores would be greater then 100%

3 month post-op

Group	Value	95% CI
BFR Exercise Group	68.02	± 13.94
Non-BFR Exercise Group	60.72	± 17.54

Return to sport (@ 6-8 months post-op)

Group	Value	95% CI
BFR Exercise Group	89.53	± 27.74
Non-BFR Exercise Group	80.97	± 10.69

Isometric Hamstring Strength Peak Torque Primary · at 3 months post-op and return to sport (between approximately 6-8 months post-op)

Isometric strength testing to measure peak torque hamstring strength (unit:nm/kg) as reported by isokinetic dynamometer on involved and uninvolved limb.

3 months post-op

Group	Value	95% CI
BFR Exercise Group	1.20	± 0.51
Non-BFR Exercise Group	1.61	± 0.36

return to sport (between approximately 6-8 months post-op)

Group	Value	95% CI
BFR Exercise Group	1.53	± 0.30
Non-BFR Exercise Group	1.3	± 0.41

Isometric Hamstring Strength Limb Symmetry Index Primary · 3 months post op and return to sport (between approximately 6-8 months post-op)

Hamstring limb symmetry index is calculated by taking the values from outcome 3 \[ ( peak torque hamstring involved limb (nm-kg) / peak torque hamstring uninvolved limb (nm-kg))\*100\] as reported by isokinetic dynamometer. This value is expressed as a percentage.100% would equal symmetry. For patients that demonstrate a stronger involved limb then uninvolved limb symmetry will be reported as greater then 100%

3 months post-op

Group	Value	95% CI
BFR Exercise Group	108.32	± 21.41
Non-BFR Exercise Group	80.3	± 14.71

return to sport (between approximately 6-8 months post-op)

Group	Value	95% CI
BFR Exercise Group	96.74	± 11.68
Non-BFR Exercise Group	85.61	± 16.21

Pedi-IKDC (International Knee Documentation Committee) Secondary · at 3 months post-op and return to sport (between approximately 6-8 months post-op)

Patient Reported Outcome Measure- Scores range from 0 points (lowest level of function or highest level of symptoms) to 100 points (highest level of function and lowest level of symptoms).

3 months

Group	Value	95% CI
BFR Exercise Group	68.91	± 9.68
Non-BFR Exercise Group	71.82	± 16.78

return to sport (between approximately 6-8 months post-op)

Group	Value	95% CI
BFR Exercise Group	89.42	± 7.94
Non-BFR Exercise Group	80.90	± 8.04

Sponsor's own description

While there are a number studies that have reported on the use of BFR in the adult population, there is limited information about the use of BFR in the adolescent population. This study aims to evaluate the use of BFR training in conjunction with traditional ACL (anterior cruciate ligament) reconstruction rehabilitation in adolescents.

The purpose of this study is to evaluate the addition of BFR-based exercise to traditional methods of physical therapy. Does the use of BFR-based exercise improve strength, hypertrophy, functional and patient reported outcomes after ACL Reconstruction in the adolescent population?

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Early- and Late-Stage Benefits of Blood Flow Restriction Training on Knee Strength in Adolescents After Anterior Cruciate Ligament Reconstruction.
   Roman DP, Burland JP, Fredericks A, Giampetruzzi N, et al · · 2023 · cited 7× · PMID 38035209 · DOI 10.1177/23259671231213034