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

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ClinicalTrials.gov Identifier: NCT03035266
Recruitment Status : Recruiting
First Posted : January 27, 2017
Last Update Posted : February 8, 2019
Sponsor:
Information provided by (Responsible Party):
John Mason, Keller Army Community Hospital

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.

Condition or disease Intervention/treatment Phase
Knee Injuries Device: Blood Flow Restriction Other: Standard rehabilitation Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel 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.
Masking: Double (Investigator, Outcomes Assessor)
Masking Description: Investigators recording thigh girth and isokinetic data will be blinded to group assignment.
Primary Purpose: Treatment
Official Title: The Effect of Blood Flow Restriction Training on Muscle Atrophy Following Knee Surgery; A Randomized Control Trial
Actual Study Start Date : April 5, 2017
Estimated Primary Completion Date : August 12, 2020
Estimated Study Completion Date : August 12, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Blood Flow Restriction (BFR)
All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation. One week following surgery, subjects randomized to the BFR group will begin combining BFR with all lower extremity strengthening exercises supervised in clinic up to 3 times per week for 12 weeks.
Device: Blood 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.

Active Comparator: Standard rehabilitation (control group)
All subjects will perform traditional post-operative rehabilitation until discharge from the hospital following surgery and continue until formal discharge from physical therapy upon completion of rehabilitation.
Other: Standard rehabilitation
Standard of care for post-operative condition




Primary Outcome Measures :
  1. Peak Torque (foot-pounds), best repetition out of 15 repetitions [ Time Frame: 12 weeks and 6 months post operative ]
    Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second


Secondary Outcome Measures :
  1. Thigh circumference (centimeters) [ Time Frame: baseline, 6 weeks, 12 weeks, and 6 months ]

    Change in girth measurements of thigh:

    10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease


  2. Visual Analog Scale (VAS), 0 to 40 mm self report pain scale [ Time Frame: baseline, 6 weeks, 12 weeks, and 6 months ]
    Change in VAS for Pain

  3. Lower Extremity Functional Scale (LEFS) Questionnaire [ Time Frame: baseline, 6 weeks, 12 weeks, and 6 months ]
    Change in LEFS Outcome Measure



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03035266


Contacts
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Contact: John S Mason, DSc, DPT 845-938-3067 john.s.mason14.mil@mail.mil
Contact: Michael S Crowell, DSc, DPT 845-938-3067 michael.s.crowell.mil@mail.mil

Locations
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United States, New York
Keller Army Community Hospital Recruiting
West Point, New York, United States, 10996
Contact: John S Mason, DSc, PT    845-938-3067      
Principal Investigator: John S Mason, DSc         
United States, North Carolina
Womack Army Medical Center Completed
Fort Bragg, North Carolina, United States, 28310
United States, Texas
William Beaumont Army Medical Center Withdrawn
Fort Bliss, Texas, United States, 79920
Sponsors and Collaborators
Keller Army Community Hospital
Investigators
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Principal Investigator: John S Mason, DSc, DPT Keller Army Community Hospital

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Responsible Party: John Mason, Assistant Chief, PT, Keller Army Community Hospital
ClinicalTrials.gov Identifier: NCT03035266     History of Changes
Other Study ID Numbers: 16KACH016
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: February 8, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by John Mason, Keller Army Community Hospital:
blood flow restriction
strength
muscle atrophy
post-operative therapy
knee

Additional relevant MeSH terms:
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Atrophy
Knee Injuries
Muscular Atrophy
Pathological Conditions, Anatomical
Leg Injuries
Wounds and Injuries
Neuromuscular Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms