Total Knee ArthroplastyCOMBONCT04347343
Combined NMES and BFR Training After TKA
A study testing Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction in people with Total Knee Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Nov 2019to 3 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo primary unilateral total knee arthroplasty secondary to end-stage osteoarthritis
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Colorado Anschutz Medical Campus
Aurora, Colorado, 80045
About this study
Official title: 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.
Read the 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.
- Conditions
- Total Knee Arthroplasty
- Being tested
- Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction
- Keywords
- Blood Flow Restriction, Neuromuscular Electrical Stimulation, BFR, NMES, Rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow RestrictionProcedure or surgery
Also called Blood Flow Restriction, Occlusion Training, BFR, Neuromuscular Electrical Stimulation
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.
| Study group | Role | What they receive |
|---|---|---|
| COMBO | Experimental | Neuromuscular Electrical Stimulation and Blood Flow Restriction (COMBO) in addition to standard postoperative rehabilitation. Receives: Procedure: Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quadriceps Strength From Baseline to 8 Weeks
Assesses the maximal voluntary isometric contraction strength of the quadriceps muscle using an electromechanical dynamometer.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Secondary outcomes (9)
Change in Quadriceps Activation From Baseline to 8 Weeks
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.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Change in Knee Range of Motion (ROM) From Baseline to 8 Weeks
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.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Change in Timed Up and Go (TUG) From Baseline to 8 Weeks
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.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Change in 30-Second Sit-to-Stand Test (30-STS) From Baseline to 8 Weeks
Assesses lower body strength and the fatigue effect caused by the number of sit-to-stand repetitions that can performed in 30 seconds.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Change in Stair Climbing Test From Baseline to 8 Weeks
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.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Change in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) From Baseline to 8 Weeks
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.
Measured: Baseline, 4 weeks and 8 weeks after surgery
Adherence to the Intervention as measured by home exercise program logs
Assesses the adherence of subjects and informs feasibility of intervention. Measured by home exercise program logs.
Measured: 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".
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.
Measured: 8 weeks after surgery
Safety of COMBO program as measured by adverse events reported per IRB procedures.
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.
Measured: 4 weeks and 8 weeks after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start22 Nov 2019
- Primary completion3 Feb 2022
- Study completion3 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Total Knee ArthroplastyStudies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Delphi Medical Innovations Inc.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04347343
- Sponsor's protocol ID
- 19-1433
- Acronym
- COMBO
- Status last verified
- Feb 2022
- First submitted
- 13 Apr 2020
- Last updated
- 7 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 15866968Stevens 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.
PubMed 12919862Bade 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.
PubMed 20710093Huang 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.
PubMed 8653948Rantanen 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.
PubMed 9715919Skelton 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.
PubMed 7825481Moreland 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.
PubMed 15209650Brown 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.
PubMed 7493219Connelly 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.
PubMed 9402571Moxley 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.
PubMed 10469937Mizner 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.
PubMed 16108583Stevens-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.
PubMed 22095207Yue 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.
PubMed 29530519Demircioglu 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.
PubMed 26355656Hughes 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.
PubMed 28259850
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combined Neuromuscular Electrical Stimulation and Blood Flow Restriction Training After Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04347343
- Acronym / sponsor ID
- COMBO / 19-1433
- Conditions
- Total Knee Arthroplasty
- Keywords
- Blood Flow Restriction, Neuromuscular Electrical Stimulation, BFR, NMES, Rehabilitation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Delphi Medical Innovations Inc.
- Study start
- 22 Nov 2019 (actual)
- Primary completion
- 3 Feb 2022 (actual)
- Study completion
- 3 Feb 2022 (actual)
- First posted
- 15 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COMBO | Experimental | Procedure: Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow RestrictionNeuromuscular Electrical Stimulation and Blood Flow Restriction (COMBO) in addition to standard postoperative rehabilitation. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Scheduled to undergo primary unilateral total knee arthroplasty secondary to end-stage osteoarthritis
Key exclusion criteria (13 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow RestrictionAlso: Blood Flow Restriction, Occlusion Training, BFR, Neuromuscular Electrical StimulationSubjects 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. | Procedure or surgery | COMBO |
Primary outcome
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.
9 secondary outcomes
Change in Quadriceps Activation From Baseline to 8 Weeks
Time frame: 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
Change in Timed Up and Go (TUG) From Baseline to 8 Weeks
Time frame: 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
Change in Stair Climbing Test From Baseline to 8 Weeks
Time frame: 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
Adherence to the Intervention as measured by home exercise program logs
Time frame: 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
Safety of COMBO program as measured by adverse events reported per IRB procedures.
Time frame: 4 weeks and 8 weeks after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2022.
- Background: PubMed 15866968Mizner 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.
- Background: PubMed 12919862Stevens 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.
- Background: PubMed 20710093Bade 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.
- Background: PubMed 8653948Huang 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.
- Background: PubMed 9715919Rantanen 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.
- Background: PubMed 7825481Skelton 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.
- Background: PubMed 15209650Moreland 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.
- Background: PubMed 7493219Brown 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.
- Background: PubMed 9402571Connelly 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.
- Background: PubMed 10469937Moxley 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.
- Background: PubMed 16108583Mizner 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.
- Background: PubMed 22095207Stevens-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Standard Rehabilitation + Neuromuscular Electrical Stimulation and Blood Flow Restriction in people with Total Knee Arthroplasty, run by University of Colorado, Denver at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quadriceps Strength From Baseline to 8 Weeks (time frame: Baseline, 4 weeks and 8 weeks after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04347343, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2022.