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

Primary Purpose

Knee Injuries

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Blood Flow Restriction
Standard rehabilitation
Sponsored by
Keller Army Community Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Injuries focused on measuring blood flow restriction, strength, muscle atrophy, post-operative therapy, knee

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Keller Army Community Hospital
  • Womack Army Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Blood Flow Restriction (BFR)

Standard rehabilitation (control group)

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Peak Torque (foot-pounds), best repetition out of 15 repetitions
Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second

Secondary Outcome Measures

Thigh circumference (centimeters)
Change 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 scale
Change in VAS for Pain
Lower Extremity Functional Scale (LEFS) Questionnaire
Change in LEFS Outcome Measure

Full Information

First Posted
January 20, 2017
Last Updated
August 19, 2020
Sponsor
Keller Army Community Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03035266
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
April 5, 2017 (Actual)
Primary Completion Date
March 12, 2020 (Actual)
Study Completion Date
March 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Keller Army Community Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Injuries
Keywords
blood flow restriction, strength, muscle atrophy, post-operative therapy, knee

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
InvestigatorOutcomes Assessor
Masking Description
Investigators recording thigh girth and isokinetic data will be blinded to group assignment.
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Blood Flow Restriction (BFR)
Arm Type
Experimental
Arm Description
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.
Arm Title
Standard rehabilitation (control group)
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Blood Flow Restriction
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard rehabilitation
Intervention Description
Standard of care for post-operative condition
Primary Outcome Measure Information:
Title
Peak Torque (foot-pounds), best repetition out of 15 repetitions
Description
Change in isokinetic peak torque knee extension and knee flexion at 180 degrees/sec and at 300 degrees/second
Time Frame
12 weeks and 6 months post operative
Secondary Outcome Measure Information:
Title
Thigh circumference (centimeters)
Description
Change in girth measurements of thigh: 10 cm from proximal patella 15 cm from proximal patella 33% length from proximal patella to inguinal crease
Time Frame
baseline, 6 weeks, 12 weeks, and 6 months
Title
Visual Analog Scale (VAS), 0 to 40 mm self report pain scale
Description
Change in VAS for Pain
Time Frame
baseline, 6 weeks, 12 weeks, and 6 months
Title
Lower Extremity Functional Scale (LEFS) Questionnaire
Description
Change in LEFS Outcome Measure
Time Frame
baseline, 6 weeks, 12 weeks, and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
John S Mason, DSc, DPT
Organizational Affiliation
Keller Army Community Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Keller Army Community Hospital
City
West Point
State/Province
New York
ZIP/Postal Code
10996
Country
United States
Facility Name
Womack Army Medical Center
City
Fort Bragg
State/Province
North Carolina
ZIP/Postal Code
28310
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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

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