Combined NMES and BFR Training After TKA (COMBO)

February 18, 2022 updated by: University of Colorado, Denver

Combined Neuromuscular Electrical Stimulation and Blood Flow Restriction Training After Total Knee Arthroplasty

The purpose of this feasibility study is to determine the initial efficacy of early combined Neuromuscular Electrical Stimulation (NMES) and Blood Flow Restriction (BFR) in addition to standard rehabilitation in 15 subjects after Total Knee Arthroplasty (TKA). The second aim is to determine the feasibility and patient perceptions of combined NMES and BFR by assessing: 1) adherence, 2) satisfaction and 3) safety.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

It's estimated that almost 3.5 million Total Knee Arthroplasties (TKA) will be performed annually by 2030. Despite initiating rehabilitation within 48 hours of surgery, up to a 60% strength loss is noted in the quadriceps one month after TKA. This weakness persists for years after surgery and is associated with decreased gait speed, balance, stair climbing ability and is associated with an increased risk for falls. Approximately 85% of the strength loss after TKA is explained by the combination of voluntary muscle activation deficits and muscle atrophy. Immediately postoperatively, strength loss is primarily due to activation deficits, and as time progresses, muscle atrophy becomes the major contributing factor. Early in the postoperative period, Neuromuscular Electrical Stimulation (NMES) has been shown to diminish activation deficits and improve function after TKA. Blood Flow Restriction (BFR) is a proposed strength training alternative for people who are unable to tolerate traditional strength training at 70-80% of their 1 repetition maximum (1RM), such as those who have just had surgery. Performing low intensity exercise (20-30% of 1RM) with BFR has been shown to achieve similar muscle mass and strength gains when compared to high intensity resistance training. BFR has been studied in people with TKA, but it has been used later in the recovery period (>6 weeks postoperative) when the greatest strength losses have already occurred. The goal of this study is to address both factors of postoperative quadriceps weakness, activation deficit and atrophy, through the use of early NMES and BFR in addition to standard postoperative rehabilitation in an attempt to minimize strength loss and improve functional outcomes.

AIM 1: To determine the initial efficacy of combined neuromuscular electrical stimulation and blood flow restriction training (COMBO) on strength (primary outcome), activation, pain, range of motion, and function compared to historical controls.

Hypothesis 1.1: The COMBO group will have greater attenuation of early postoperative strength losses and improved pain, ROM, and function compared to historical controls.

AIM 2: To determine the feasibility of COMBO by assessing 1) adherence, 2) satisfaction, and 3) safety

Hypothesis 2.1: An 80% adherence rate to the intervention will be observed.

Hypothesis 2.2: Study participants will indicate acceptability of COMBO with a satisfaction survey median score of at least 4/5 ("somewhat satisfied").

Hypothesis 2.3: There will be no intervention-related Adverse Events or Serious Adverse Events during the 8-week protocol.

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Anschutz Medical Campus

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

48 years to 83 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Scheduled to undergo primary unilateral total knee arthroplasty secondary to end-stage osteoarthritis

Exclusion Criteria:

  • BMI > 40 kgm2
  • Current smoker or history of drug abuse
  • Comorbid conditions that substantially limit physical function or would interfere with the participant's ability to successfully complete rehabilitation (e.g. neurologic, vascular, cardiac problems, or ongoing medical treatments)
  • Unstable orthopedic conditions that limit function
  • Uncontrolled diabetes (hemoglobin A1c level > 8.0)
  • Pregnancy
  • Preoperative ROM less than 10-120 degrees
  • Demand cardiac pacemaker or unstable arrhythmia
  • Prior history of DVT/PE
  • Thrombophilia or other clotting disorders
  • Sickle cell trait/anemia
  • History of peripheral vascular disease
  • Patient report of easy bruising

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: COMBO
Neuromuscular Electrical Stimulation and Blood Flow Restriction (COMBO) in addition to standard postoperative rehabilitation.
Procedure: Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction

Subjects will begin a standardized protocol on post-op day 2. Outpatient visits will be 2x/wk for weeks 0-4 and then 1x/wk for weeks 5-8.

Subjects will utilize NMES on the quadriceps in the home setting 2x/day for the first 3-4 weeks during isometric contractions at their highest tolerated intensity. Total treatment will begin at 10 minutes.

At the end of post-op week 2, subjects will be exposed in clinic to BFR on the surgical limb increasing to 80% limb occlusion pressure over weeks 3-4 as tolerated. Initially, BFR and NMES will be performed simultaneously. BFR will then be progressed using active exercises. After completing a safety checklist, subjects will be issued a home BFR unit for use 2x/week (3x total including clinic visit) at which time NMES will be discontinued. BFR exercise intensity will be progressed as tolerated to maintain 20-30% of 1RM.

Other Names:
  • NMES
  • Blood Flow Restriction
  • Occlusion Training
  • BFR
  • Neuromuscular Electrical Stimulation

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quadriceps Strength From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle using an electromechanical dynamometer.
Baseline, 4 weeks and 8 weeks after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quadriceps Activation From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses voluntary activation of the quadriceps using the doublet interpolation technique, where a supramaximal stimulus is applied during a maximal voluntary isometric contraction and again immediately afterward, while the quadriceps muscle is at rest.
Baseline, 4 weeks and 8 weeks after surgery
Change in Knee Range of Motion (ROM) From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses the mobility of the knee joint. Knee ROM will be measured in the supine position both actively and passively using a long-arm goniometer.
Baseline, 4 weeks and 8 weeks after surgery
Change in Timed Up and Go (TUG) From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Evaluates mobility through the time required to rise from an arm chair, walk 3 meters, turn and walk back to the arm chair, and return to a seated position.
Baseline, 4 weeks and 8 weeks after surgery
Change in 30-Second Sit-to-Stand Test (30-STS) From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses lower body strength and the fatigue effect caused by the number of sit-to-stand repetitions that can performed in 30 seconds.
Baseline, 4 weeks and 8 weeks after surgery
Change in Stair Climbing Test From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses lower body strength, power and balance as measured through the time required to ascend and descend a flight of stairs. Measures a higher level of function that minimizes the possibility of a ceiling effect.
Baseline, 4 weeks and 8 weeks after surgery
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline to 8 Weeks
Time Frame: Baseline, 4 weeks and 8 weeks after surgery
Assesses self-reported physical function. Scales assess pain, stiffness, and physical function in patients with hip and / or knee osteoarthritis. Total score range is 0-96. Total score is computed by summing three subscales: pain (range 0-20), stiffness (range 0-8), and functional limitations (range 0-68), then dividing by total points possible. Higher scores indicate worse pain, stiffness, and functional limitations.
Baseline, 4 weeks and 8 weeks after surgery
Adherence to the Intervention as measured by home exercise program logs
Time Frame: 4 weeks and 8 weeks after surgery
Assesses the adherence of subjects and informs feasibility of intervention. Measured by home exercise program logs.
4 weeks and 8 weeks after surgery
Satisfaction with Rehabilitation Program as measured by a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied".
Time Frame: 8 weeks after surgery
Assesses the satisfaction of subjects using a 5-point Likert scale ranging from "very unsatisfied" to "very satisfied" in each of the following rehabilitation program components: overall rehabilitation program, BFR, NMES, and home exercise program. Informs feasibility of intervention.
8 weeks after surgery
Safety of COMBO program as measured by adverse events reported per IRB procedures.
Time Frame: 4 weeks and 8 weeks after surgery
Assess safety of intervention as measured by adverse events related to the COMBO program reported per IRB procedures. Adverse events will be documented at all clinic and testing sessions.
4 weeks and 8 weeks after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Colorado, Denver

Collaborators

Delphi Medical Innovations Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2019

Primary Completion (Actual)

February 3, 2022

Study Completion (Actual)

February 3, 2022

Study Registration Dates

First Submitted

April 13, 2020

First Submitted That Met QC Criteria

April 13, 2020

First Posted (Actual)

April 15, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2022

Last Update Submitted That Met QC Criteria

February 18, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 19-1433

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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