Combined NMES and BFR Training After TKA

NCT04347343 | Completed

• 1 other identifier: 19-1433
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Total Knee Arthroplasty

Keywords

Blood Flow Restriction; Neuromuscular Electrical Stimulation; BFR; NMES; Rehabilitation

Outcome Measures

Primary Outcomes (1)

• Change in Quadriceps Strength From Baseline to 8 Weeks

  Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle using an electromechanical dynamometer.

  Baseline, 4 weeks and 8 weeks after surgery

Secondary Outcomes (9)

• Change in Quadriceps Activation From Baseline to 8 Weeks

  Baseline, 4 weeks and 8 weeks after surgery

• Change in Knee Range of Motion (ROM) From Baseline to 8 Weeks

  Baseline, 4 weeks and 8 weeks after surgery

• Change in Timed Up and Go (TUG) From Baseline to 8 Weeks

  Baseline, 4 weeks and 8 weeks after surgery

• Change in 30-Second Sit-to-Stand Test (30-STS) From Baseline to 8 Weeks

  Baseline, 4 weeks and 8 weeks after surgery

• Change in Stair Climbing Test From Baseline to 8 Weeks

  Baseline, 4 weeks and 8 weeks after surgery

Study Arms (1)

COMBO

EXPERIMENTAL

Neuromuscular Electrical Stimulation and Blood Flow Restriction (COMBO) in addition to standard postoperative rehabilitation.

Procedure: Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction

Interventions

Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction PROCEDURE

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.

Also known as: Blood Flow Restriction, Occlusion Training, BFR, Neuromuscular Electrical Stimulation, NMES

COMBO

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Delphi Medical Innovations Inc.: collaborator

Study Sites (1)

University of Colorado Anschutz Medical Campus

Aurora, Colorado, 80045, United States

Location

Related Publications (18)

• Mizner RL, Petterson SC, Stevens JE, Vandenborne K, Snyder-Mackler L. Early quadriceps strength loss after total knee arthroplasty. The contributions of muscle atrophy and failure of voluntary muscle activation. J Bone Joint Surg Am. 2005 May;87(5):1047-53. doi: 10.2106/JBJS.D.01992.

  PMID: 15866968 BACKGROUND

• Stevens JE, Mizner RL, Snyder-Mackler L. Quadriceps strength and volitional activation before and after total knee arthroplasty for osteoarthritis. J Orthop Res. 2003 Sep;21(5):775-9. doi: 10.1016/S0736-0266(03)00052-4.

  PMID: 12919862 BACKGROUND

• Bade MJ, Kohrt WM, Stevens-Lapsley JE. Outcomes before and after total knee arthroplasty compared to healthy adults. J Orthop Sports Phys Ther. 2010 Sep;40(9):559-67. doi: 10.2519/jospt.2010.3317.

  PMID: 20710093 BACKGROUND

• Huang CH, Cheng CK, Lee YT, Lee KS. Muscle strength after successful total knee replacement: a 6- to 13-year followup. Clin Orthop Relat Res. 1996 Jul;(328):147-54. doi: 10.1097/00003086-199607000-00023.

  PMID: 8653948 BACKGROUND

• Rantanen T, Guralnik JM, Izmirlian G, Williamson JD, Simonsick EM, Ferrucci L, Fried LP. Association of muscle strength with maximum walking speed in disabled older women. Am J Phys Med Rehabil. 1998 Jul-Aug;77(4):299-305. doi: 10.1097/00002060-199807000-00008.

  PMID: 9715919 BACKGROUND

• Skelton DA, Greig CA, Davies JM, Young A. Strength, power and related functional ability of healthy people aged 65-89 years. Age Ageing. 1994 Sep;23(5):371-7. doi: 10.1093/ageing/23.5.371.

  PMID: 7825481 BACKGROUND

• Moreland JD, Richardson JA, Goldsmith CH, Clase CM. Muscle weakness and falls in older adults: a systematic review and meta-analysis. J Am Geriatr Soc. 2004 Jul;52(7):1121-9. doi: 10.1111/j.1532-5415.2004.52310.x.

  PMID: 15209650 BACKGROUND

• Brown M, Sinacore DR, Host HH. The relationship of strength to function in the older adult. J Gerontol A Biol Sci Med Sci. 1995 Nov;50 Spec No:55-9. doi: 10.1093/gerona/50a.special_issue.55.

  PMID: 7493219 BACKGROUND

• Connelly DM, Vandervoort AA. Effects of detraining on knee extensor strength and functional mobility in a group of elderly women. J Orthop Sports Phys Ther. 1997 Dec;26(6):340-6. doi: 10.2519/jospt.1997.26.6.340.

  PMID: 9402571 BACKGROUND

• Moxley Scarborough D, Krebs DE, Harris BA. Quadriceps muscle strength and dynamic stability in elderly persons. Gait Posture. 1999 Sep;10(1):10-20. doi: 10.1016/s0966-6362(99)00018-1.

  PMID: 10469937 BACKGROUND

• Mizner RL, Petterson SC, Snyder-Mackler L. Quadriceps strength and the time course of functional recovery after total knee arthroplasty. J Orthop Sports Phys Ther. 2005 Jul;35(7):424-36. doi: 10.2519/jospt.2005.35.7.424.

  PMID: 16108583 BACKGROUND

• Stevens-Lapsley JE, Balter JE, Wolfe P, Eckhoff DG, Kohrt WM. Early neuromuscular electrical stimulation to improve quadriceps muscle strength after total knee arthroplasty: a randomized controlled trial. Phys Ther. 2012 Feb;92(2):210-26. doi: 10.2522/ptj.20110124. Epub 2011 Nov 17.

  PMID: 22095207 BACKGROUND

• Yue C, Zhang X, Zhu Y, Jia Y, Wang H, Liu Y. Systematic Review of Three Electrical Stimulation Techniques for Rehabilitation After Total Knee Arthroplasty. J Arthroplasty. 2018 Jul;33(7):2330-2337. doi: 10.1016/j.arth.2018.01.070. Epub 2018 Feb 6.

  PMID: 29530519 BACKGROUND

• Demircioglu DT, Paker N, Erbil E, Bugdayci D, Emre TY. The effect of neuromuscular electrical stimulation on functional status and quality of life after knee arthroplasty: a randomized controlled study. J Phys Ther Sci. 2015 Aug;27(8):2501-6. doi: 10.1589/jpts.27.2501. Epub 2015 Aug 21.

  PMID: 26355656 BACKGROUND

• Hughes L, Paton B, Rosenblatt B, Gissane C, Patterson SD. Blood flow restriction training in clinical musculoskeletal rehabilitation: a systematic review and meta-analysis. Br J Sports Med. 2017 Jul;51(13):1003-1011. doi: 10.1136/bjsports-2016-097071. Epub 2017 Mar 4.

  PMID: 28259850 BACKGROUND

• Tennent DJ, Hylden CM, Johnson AE, Burns TC, Wilken JM, Owens JG. Blood Flow Restriction Training After Knee Arthroscopy: A Randomized Controlled Pilot Study. Clin J Sport Med. 2017 May;27(3):245-252. doi: 10.1097/JSM.0000000000000377.

  PMID: 27749358 BACKGROUND

• Gaunder CL, Hawkinson MP, Tennent DJ, Tubb CC. Occlusion training: pilot study for postoperative lower extremity rehabilitation following primary total knee arthroplasty. US Army Med Dep J. 2017 Jul-Sep;(2-17):39-43.

  PMID: 28853118 BACKGROUND

• Kittelson AJ, Stackhouse SK, Stevens-Lapsley JE. Neuromuscular electrical stimulation after total joint arthroplasty: a critical review of recent controlled studies. Eur J Phys Rehabil Med. 2013 Dec;49(6):909-20. Epub 2013 Nov 28.

  PMID: 24285026 BACKGROUND

MeSH Terms

Interventions

Blood Flow Restriction Therapy

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 13, 2020
• First Posted: April 15, 2020
• Study Start: November 22, 2019
• Primary Completion: February 3, 2022
• Study Completion: February 3, 2022
• Last Updated: March 7, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)