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

NCT03035266 | Completed

• 1 other identifier: 16KACH016
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 2

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.

Conditions

Knee Injuries

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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

  12 weeks and 6 months post operative

Secondary Outcomes (3)

• Thigh circumference (centimeters)

  baseline, 6 weeks, 12 weeks, and 6 months

• Visual Analog Scale (VAS), 0 to 40 mm self report pain scale

  baseline, 6 weeks, 12 weeks, and 6 months

• Lower Extremity Functional Scale (LEFS) Questionnaire

  baseline, 6 weeks, 12 weeks, and 6 months

Study Arms (2)

Blood Flow Restriction (BFR)

EXPERIMENTAL

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.

Other: Blood Flow Restriction

Standard rehabilitation (control group)

ACTIVE COMPARATOR

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

Interventions

Blood Flow Restriction OTHER

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.

Blood Flow Restriction (BFR)

Standard rehabilitation OTHER

Standard of care for post-operative condition

Standard rehabilitation (control group)

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Keller Army Community Hospital: lead

Study Sites (2)

Keller Army Community Hospital

West Point, New York, 10996, United States

Location

Womack Army Medical Center

Fort Bragg, North Carolina, 28310, United States

Location

MeSH Terms

Conditions

Knee Injuries; Muscular Atrophy

Interventions

Blood Flow Restriction Therapy

Condition Hierarchy (Ancestors)

Leg Injuries; Wounds and Injuries; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities

Study Officials

• John S Mason, DSc, DPT

  Keller Army Community Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Investigators recording thigh girth and isokinetic data will be blinded to group assignment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Chief, PT

Model Details: 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.

Study Record Dates

• First Submitted: January 20, 2017
• First Posted: January 27, 2017
• Study Start: April 5, 2017
• Primary Completion: March 12, 2020
• Study Completion: March 12, 2020
• Last Updated: August 21, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)