Clinical trial NCT03035266: The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery
Official title: The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Knee Injuries
Keywords: blood flow restriction
strength
muscle atrophy
post-operative therapy
knee
Lead sponsor: Keller Army Community Hospital
Sponsor class: FED
First posted: 2017-01-27
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Peak Torque (foot-pounds), best repetition out of 15 repetitions
timeFrame: 12 weeks and 6 months post operative
Secondary outcomes:
measure: Thigh circumference (centimeters)
timeFrame: baseline, 6 weeks, 12 weeks, and 6 months
measure: Visual Analog Scale (VAS), 0 to 40 mm self report pain scale
timeFrame: baseline, 6 weeks, 12 weeks, and 6 months
measure: Lower Extremity Functional Scale (LEFS) Questionnaire
timeFrame: baseline, 6 weeks, 12 weeks, and 6 months
Other outcomes:
Locations:
city: West Point
country: United States
facility: Keller Army Community Hospital
state: New York
city: Fort Bragg
country: United States
facility: Womack Army Medical Center
state: North Carolina
Study officials:
affiliation: Keller Army Community Hospital
name: John S Mason, DSc, DPT
role: PRINCIPAL_INVESTIGATOR
References: