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The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery

The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03035266
Enrollment
22
Registered
2017-01-27
Start date
2017-04-05
Completion date
2020-03-12
Last updated
2020-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Knee Injuries

Keywords

blood flow restriction, strength, muscle atrophy, post-operative therapy, knee

Brief summary

The investigators will compare differences in quadriceps strength, leg girth, and functional outcome scores between two groups of patients after weeks 6 and 12 as well as 6 months following meniscus or articular cartilage repair/restoration requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0° degrees of knee extension. One group will receive BFR with standard post-operative rehabilitation for 12 weeks followed by the standard protocol progression for the remainder of the treatment program. The other group will receive standard post-operative rehabilitation without BFR for the duration of treatment program.

Detailed description

The aim is to compare strength, patient reported outcomes, and functional outcomes of post-operative therapy with and without adjunctive BFR training. To accomplish this task the investigators will compare differences in thigh girth between two groups of patients after the first 6 weeks and 12 weeks as well as 6 months following meniscus or articular cartilage repair requiring 6 weeks of non-weight bearing or limited weight bearing status in a brace at 0˚ degrees of extension. In addition, isokinetic testing of the quadriceps and hamstrings will be performed at 12 weeks and 6 months post-operatively. Lower extremity girth measurements after knee surgery can be performed with good to excellent intra- and inter-rater reliability. Quadriceps strength measured with isokinetic testing is related to performance measures such as jumping. Limb circumference measurement, limb CSA measurement, and isokinetic strength testing are commonly utilized in BFR studies as outcome measures.One group will receive BFR for 12 weeks in addition to standard post-operative rehabilitation and the other group will receive standard post-operative rehabilitation without BFR.

Interventions

OTHERBlood Flow Restriction

Delfi's Personalized Tourniquet System for Blood Flow Restriction has been specifically designed to safely regulate and control tourniquet pressure. Occlusion pressures will be set at 80% of total occlusive pressure as determined by the Doppler sensor. Each subject will perform 4 sets of each exercise (1 set of 30 repetitions followed by 3 sets of 15 repetitions). The pressure will remain through completion of the final set, but not to exceed 5 minutes. One minute rest without tourniquet application will be performed between 5 minute cycles. Sets and repetitions will remain constant for each subject; however, resistance will be incrementally increased after the subject is able to complete all 75 repetitions without loss of proper form.

OTHERStandard rehabilitation

Standard of care for post-operative condition

Sponsors

Keller Army Community Hospital
Lead SponsorFED

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)

Masking description

Investigators recording thigh girth and isokinetic data will be blinded to group assignment.

Intervention model description

This is a prospective, randomized control trial. After consenting, subjects will be randomized to one of two groups by using a computer generated random number.

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No

Inclusion criteria

* Military healthcare beneficiaries between the age of 18 and 50 years. * Must intend to remain on station at location of surgery for 6 months from date of surgery. * Meniscus repair or cartilage restoration technique to include microfracture, osteochondral autograft transfer system, osteochondral allograft transplantation, and autologous chondrocyte implantation following standard post-operative protocol guidelines requiring a 6 week period of non-weight bearing or limited weight bearing in a brace at 0˚ degrees of extension.

Exclusion criteria

* Concomitant ligamentous repair/reconstruction * Known pregnancy * Any medical condition for which aerobic exercise is contraindicated * Additional back, hip, or knee surgery in the previous 12 months * History of vascular or cardiac impairment

Design outcomes

Primary

MeasureTime frameDescription
Peak Torque (foot-pounds), best repetition out of 15 repetitions12 weeks and 6 months post operativeChange in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second

Secondary

MeasureTime frameDescription
Thigh circumference (centimeters)baseline, 6 weeks, 12 weeks, and 6 monthsChange in girth measurements of thigh: 10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease
Visual Analog Scale (VAS), 0 to 40 mm self report pain scalebaseline, 6 weeks, 12 weeks, and 6 monthsChange in VAS for Pain
Lower Extremity Functional Scale (LEFS) Questionnairebaseline, 6 weeks, 12 weeks, and 6 monthsChange in LEFS Outcome Measure

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026