Knee OsteoarthritisNCT02802878
Combined Application of Electrical Stimulation and Volitional Contractions for Muscle Strengthening and Knee Pain Inhibition (Seated Study)
A study testing Hybrid Training using Electrodes and Joint Motion Sensors and Isokinetic Training with Isokinetic Dynamometer in people with Knee Osteoarthritis, run by University of Kansas Medical Center at 1 site in United States.
Trial summary
The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular electrical stimulation with volitional contraction (NMES-VC) training program to improve quadriceps strength and activation, while not adversely affecting knee-related pain, activities of daily living or quality of life in women… Read more about this study
- Who is it for?
- Ages 40 to 85 years, women only
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- Hybrid Training using Electrodes and Joint Motion Sensors and Isokinetic Training with Isokinetic Dynamometer
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2016to 14 Dec 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 40 to 85 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female
- Age 40-85 years
- One or more of the following:
- Knee symptoms (pain, aching, or stiffness) on most of the last 30 days; categorically defined, so all severity of symptoms ok, but must have knee symptoms on most days
- History of knee injury or surgery
- Body Mass Index (BMI) greater than or equal to 25 kg/m2
- BMI less than 45 kg/m2
Who cannot join
- Knee injection within 6 weeks prior to the study
- Resistance training at any time in the last 3 months prior to the study
- Bilateral knee replacement
- Lower limb amputation
- Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
- Back, hip or knee problems that affect walking ability or ability to exercise
Show all 23Show fewer
- Unable to walk without a cane or walker
- Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
- Multiple sclerosis or other neurodegenerative disorder
- Known neuropathy
- Self-report of Diabetes
- Currently being treated for cancer or having untreated cancer
- Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
- Peripheral Vascular Disease
- History of myocardial infarction or stroke in the last year
- Chest pain during exercise or at rest
- Use of supplemental oxygen
- Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
- Staff concern for participant health (such as history of dizziness/faintness or current restrictions on activity)
- Unable to attend 12 or more sessions during the study
- Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or other implanted electrical device.
- Dermatitis or skin sensitivity.
- Pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Kansas Medical Center
Kansas City, Kansas, 66160
About this study
Official title: Determining the Effects of the Combined Application of Electrical Stimulation and Volitional Contractions on Muscle Strength and Knee Pain and Function in Women With or at Risk for Knee Osteoarthritis
The purpose of this study is to assess the efficacy of a 12-week low-load neuromuscular electrical stimulation with volitional contraction (NMES-VC) training program to improve quadriceps strength and activation, while not adversely affecting knee-related pain, activities of daily living or quality of life in women with knee pain. The primary outcome will be change in maximal isokinetic knee extensor torque.
The investigators will test the following hypotheses. In comparison with low-load (40%) resistance training without electrical stimulation, a 12-week NMES-VC training program will:
Read more
Hypothesis 1: Increase maximal isokinetic knee extensor torque
Secondary questions and response variables
Hypothesis 2: Not adversely affect knee pain or quality of life, assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA:
- Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development
- Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated (using numeric rating scale survey "level of pain you experienced during the hybrid training or 40% isokinetic exercise")
- Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)
Read the detailed description
Arthritis is the most common cause of disability in the United States. Approximately 42.1% of women and 31.2% of men over the age of 60 have knee osteoarthritis (KOA). KOA is associated with pain, quadriceps weakness, swelling, instability, decline of range of motion, physical function, and quality of life (QOL). The presence of KOA significantly decreases QOL, while quadriceps strengthening has the ability to improve QOL. However, one challenge with strengthening is that knee pain influences muscle strength and physical function. Not only quadriceps strengthening but also reduction of knee pain may be necessary to reduce functional limitations from KOA. However, at this time, there is insufficient evidence regarding effective training to not only increase quadriceps strength but also reduce knee pain and improve neural function. Thus, there is a need for interventional studies to build on observational findings to evaluate the relationships of neural function, knee muscle strength, knee pain, and physical function.
The critical barrier to studying whether quadriceps strengthening is protective against worsening physical function is the lack of an effective strengthening program for people at elevated risk for KOA. Factors that place older adults at elevated risk for symptomatic KOA, (e.g. sedentary lifestyle, obesity, knee pain, knee injury or surgery), may also contribute to reduced tolerance of high load quadriceps strengthening programs. If a well-tolerated and effective means of strengthening could be identified, it may also have additional benefits in reducing knee pain, improving physical function and avoiding disability in individuals with or at risk of KOA.
Neuromuscular electrical stimulation (NMES) is widely used to strengthen muscles and improve function in people who cannot exercise at medium-high intensity. For KOA, NMES is effective for enhancing quadriceps strength, knee pain, physical function. Therefore, NMES could contribute to decreased neural inhibition from knee pain and promote muscle function (e.g. muscle strength, power, contraction speed, and co-contraction). Recently, it was reported that the combined application of NMES and volitional contractions (NMES-VC) is effective for making up for a limitation of NMES. NMES-VC could help to improve motor recovery. The results of recent studies suggest that a hybrid training system that utilizes both volitional contractions and NMES simultaneously, might be an effective method that can improve physical function by strengthening muscles and relieving knee pain in people at risk for incident or progressive symptomatic KOA.
This line of research could have a significant positive impact on public health, by leading to the introduction of an inexpensive means of well-tolerated and safe exercise that can be completed in community rehabilitative environments. Successful completion of this initial investigation will enable pursuit of research to determine whether NMES-VC is effective in quadriceps strengthening and pain relief while improving neural function in symptomatic and progressive KOA. Reduction of this primary cause of disability through cost-effective preventive exercise has a high potential to reduce the burden of disease and disablement, thereby improving the quality of life for older adults and significantly reducing the costs to individuals and society.
The specific aim of the proposed research is to assess the efficacy of a twelve-week, efficient and tolerable, low-intensity exercise program with NMES-VC for improving quadriceps strength, knee pain and physical function in women with risk factors for incident symptomatic or progressive KOA. This specific aim will be achieved through a randomized, controlled trial, comparing low intensity exercise with and without NMES-VC. This research is novel in that it will be the first to use a low load regimen that will minimize the potential for adverse loading on the knee joint while still having a high likelihood to lead to clinically meaningful strength gains, pain relief and physical function improvement in older adults at elevated risk for symptomatic or progressive KOA.
- Conditions
- Knee Osteoarthritis
- Being tested
- Hybrid Training using Electrodes and Joint Motion Sensors, Isokinetic Training with Isokinetic Dynamometer
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hybrid Training using Electrodes and Joint Motion SensorsDevice
Electrodes (Sekisui Plastics Co., Tokyo, Japan) will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and on the posterior thigh over the motor points of the medial and lateral hamstrings. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM).
A joint motion sensor (Mutoh Engineering Inc., Tokyo, Japan) will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group.
Isokinetic Training with Isokinetic DynamometerDevice
Also called Resistance Training
Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.
| Study group | Role | What they receive |
|---|---|---|
| Hybrid Training | Experimental | The hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals.
Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group. Receives: Device: Hybrid Training using Electrodes and Joint Motion Sensors |
| Low Intensity Exercise | Active comparator | 40% 1-repetition maximum isokinetic training with HUMAC NORM in same repetitions/sets as experimental group. Receives: Device: Isokinetic Training with Isokinetic Dynamometer |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer.
Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque at 60°/sec, using an isokinetic dynamometer. These testing procedures will then be repeated for the other side.
Measured: Baseline and 12-week follow-up
Secondary outcomes (4)
Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer.
Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee flexor torque, using an isokinetic dynamometer.
Measured: Baseline and 12-week follow-up
Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score
The Knee Injury and Osteoarthritis Outcome Score (KOOS) Pain subscale was used at baseline and follow-up to assess participant outcomes. The pain subscale is made up of 9 questions and was scored from zero to 100, with zero corresponding to extreme knee problems and 100 corresponding to no knee problems.
Measured: Baseline and 12-week follow-up
Change in 20-meter Walk Time
A timed 20-meter walk was completed as a measure of lower limb physical performance. Participants were instructed to walk along a 20-meters straight, uninterrupted course as quickly as they could. Timing started when the participant initiated foot movement and stopped when both feet crossed the 20-meter mark. Times for two trials were recorded and the averaged.
Measured: Baseline and 12-week follow-up
Change in 5-chair Stand Time
The chair stand test is a validated measure of physical performance in adults with knee osteoarthritis. Participants were instructed to stand from a chair (seat height 44.45 cm) 5 times as quickly as they could without using their arms. Two trials were timed and averaged.
Measured: Baseline and 12-week follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2016 (estimated)
- Study startJun 2016
- Primary completion14 Dec 2016
- Study completion14 Dec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (37)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by University of Kansas Medical CenterThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Kurume University
- Responsible party
- Principal investigator, Neil Segal, MD, MS, University of Kansas Medical Center
- Investigators
- Neil A Segal, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02802878
- Sponsor's protocol ID
- STUDY00003872
- Status last verified
- Apr 2018
- First submitted
- 9 Jun 2016
- Last updated
- 18 May 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
PubMed 19407734Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.
PubMed 17013996Segal NA, Glass NA, Felson DT, Hurley M, Yang M, Nevitt M, Lewis CE, Torner JC. Effect of quadriceps strength and proprioception on risk for knee osteoarthritis. Med Sci Sports Exerc. 2010 Nov;42(11):2081-8. doi: 10.1249/MSS.0b013e3181dd902e.
PubMed 20351594Segal NA, Torner JC, Felson D, Niu J, Sharma L, Lewis CE, Nevitt M. Effect of thigh strength on incident radiographic and symptomatic knee osteoarthritis in a longitudinal cohort. Arthritis Rheum. 2009 Sep 15;61(9):1210-7. doi: 10.1002/art.24541.
PubMed 19714608van Dijk GM, Dekker J, Veenhof C, van den Ende CH; Carpa Study Group. Course of functional status and pain in osteoarthritis of the hip or knee: a systematic review of the literature. Arthritis Rheum. 2006 Oct 15;55(5):779-85. doi: 10.1002/art.22244.
PubMed 17013827McAlindon TE, Cooper C, Kirwan JR, Dieppe PA. Determinants of disability in osteoarthritis of the knee. Ann Rheum Dis. 1993 Apr;52(4):258-62. doi: 10.1136/ard.52.4.258.
PubMed 8484690Palmieri RM, Tom JA, Edwards JE, Weltman A, Saliba EN, Mistry DJ, Ingersoll CD. Arthrogenic muscle response induced by an experimental knee joint effusion is mediated by pre- and post-synaptic spinal mechanisms. J Electromyogr Kinesiol. 2004 Dec;14(6):631-40. doi: 10.1016/j.jelekin.2004.06.002.
PubMed 15491837Heroux ME, Tremblay F. Corticomotor excitability associated with unilateral knee dysfunction secondary to anterior cruciate ligament injury. Knee Surg Sports Traumatol Arthrosc. 2006 Sep;14(9):823-33. doi: 10.1007/s00167-006-0063-4. Epub 2006 Feb 25.
PubMed 16502299Palmieri RM, Ingersoll CD, Edwards JE, Hoffman MA, Stone MB, Babington JP, Cordova ML, Krause BA. Arthrogenic muscle inhibition is not present in the limb contralateral to a simulated knee joint effusion. Am J Phys Med Rehabil. 2003 Dec;82(12):910-6. doi: 10.1097/01.PHM.0000098045.04883.02.
PubMed 14627927Muraki S, Akune T, Oka H, Ishimoto Y, Nagata K, Yoshida M, Tokimura F, Nakamura K, Kawaguchi H, Yoshimura N. Incidence and risk factors for radiographic knee osteoarthritis and knee pain in Japanese men and women: a longitudinal population-based cohort study. Arthritis Rheum. 2012 May;64(5):1447-56. doi: 10.1002/art.33508.
PubMed 22135156Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001.
PubMed 9230035Aguiar GC, Do Nascimento MR, De Miranda AS, Rocha NP, Teixeira AL, Scalzo PL. Effects of an exercise therapy protocol on inflammatory markers, perception of pain, and physical performance in individuals with knee osteoarthritis. Rheumatol Int. 2015 Mar;35(3):525-31. doi: 10.1007/s00296-014-3148-2. Epub 2014 Oct 10.
PubMed 25300730Vincent KR, Vincent HK. Resistance exercise for knee osteoarthritis. PM R. 2012 May;4(5 Suppl):S45-52. doi: 10.1016/j.pmrj.2012.01.019.
PubMed 22632702Glass NA, Torner JC, Frey Law LA, Wang K, Yang T, Nevitt MC, Felson DT, Lewis CE, Segal NA. The relationship between quadriceps muscle weakness and worsening of knee pain in the MOST cohort: a 5-year longitudinal study. Osteoarthritis Cartilage. 2013 Sep;21(9):1154-9. doi: 10.1016/j.joca.2013.05.016.
PubMed 23973125Sattler M, Dannhauer T, Hudelmaier M, Wirth W, Sanger AM, Kwoh CK, Hunter DJ, Eckstein F; OAI investigators. Side differences of thigh muscle cross-sectional areas and maximal isometric muscle force in bilateral knees with the same radiographic disease stage, but unilateral frequent pain - data from the osteoarthritis initiative. Osteoarthritis Cartilage. 2012 Jun;20(6):532-40. doi: 10.1016/j.joca.2012.02.635. Epub 2012 Mar 3.
PubMed 22395037
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determining the Effects of the Combined Application of Electrical Stimulation and Volitional Contractions on Muscle Strength and Knee Pain and Function in Women With or at Risk for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT02802878
- Acronym / sponsor ID
- STUDY00003872
- Conditions
- Knee Osteoarthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Collaborators
- Kurume University
- Study start
- Jun 2016
- Primary completion
- 14 Dec 2016 (actual)
- Study completion
- 14 Dec 2016 (actual)
- First posted
- 16 Jun 2016 (estimated)
- Results
- Posted 18 May 2018
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 study is to assess the efficacy of a 12-week low-load neuromuscular electrical stimulation with volitional contraction (NMES-VC) training program to improve quadriceps strength and activation, while not adversely affecting knee-related pain, activities of daily living or quality of life in women with knee pain. The primary outcome will be change in maximal isokinetic knee extensor torque.
The investigators will test the following hypotheses. In comparison with low-load (40%) resistance training without electrical stimulation, a 12-week NMES-VC training program will:
Hypothesis 1: Increase maximal isokinetic knee extensor torque
Secondary questions and response variables
Hypothesis 2: Not adversely affect knee pain or quality of life, assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire
Additional hypotheses in women with risk factors for incident symptomatic or progressive KOA:
- Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development
- Determine the extent to which NMES-VC enhanced low-intensity exercise is tolerated (using numeric rating scale survey "level of pain you experienced during the hybrid training or 40% isokinetic exercise")
- Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)
Detailed description
Arthritis is the most common cause of disability in the United States. Approximately 42.1% of women and 31.2% of men over the age of 60 have knee osteoarthritis (KOA). KOA is associated with pain, quadriceps weakness, swelling, instability, decline of range of motion, physical function, and quality of life (QOL). The presence of KOA significantly decreases QOL, while quadriceps strengthening has the ability to improve QOL. However, one challenge with strengthening is that knee pain influences muscle strength and physical function. Not only quadriceps strengthening but also reduction of knee pain may be necessary to reduce functional limitations from KOA. However, at this time, there is insufficient evidence regarding effective training to not only increase quadriceps strength but also reduce knee pain and improve neural function. Thus, there is a need for interventional studies to build on observational findings to evaluate the relationships of neural function, knee muscle strength, knee pain, and physical function.
The critical barrier to studying whether quadriceps strengthening is protective against worsening physical function is the lack of an effective strengthening program for people at elevated risk for KOA. Factors that place older adults at elevated risk for symptomatic KOA, (e.g. sedentary lifestyle, obesity, knee pain, knee injury or surgery), may also contribute to reduced tolerance of high load quadriceps strengthening programs. If a well-tolerated and effective means of strengthening could be identified, it may also have additional benefits in reducing knee pain, improving physical function and avoiding disability in individuals with or at risk of KOA.
Neuromuscular electrical stimulation (NMES) is widely used to strengthen muscles and improve function in people who cannot exercise at medium-high intensity. For KOA, NMES is effective for enhancing quadriceps strength, knee pain, physical function. Therefore, NMES could contribute to decreased neural inhibition from knee pain and promote muscle function (e.g. muscle strength, power, contraction speed, and co-contraction). Recently, it was reported that the combined application of NMES and volitional contractions (NMES-VC) is effective for making up for a limitation of NMES. NMES-VC could help to improve motor recovery. The results of recent studies suggest that a hybrid training system that utilizes both volitional contractions and NMES simultaneously, might be an effective method that can improve physical function by strengthening muscles and relieving knee pain in people at risk for incident or progressive symptomatic KOA.
This line of research could have a significant positive impact on public health, by leading to the introduction of an inexpensive means of well-tolerated and safe exercise that can be completed in community rehabilitative environments. Successful completion of this initial investigation will enable pursuit of research to determine whether NMES-VC is effective in quadriceps strengthening and pain relief while improving neural function in symptomatic and progressive KOA. Reduction of this primary cause of disability through cost-effective preventive exercise has a high potential to reduce the burden of disease and disablement, thereby improving the quality of life for older adults and significantly reducing the costs to individuals and society.
The specific aim of the proposed research is to assess the efficacy of a twelve-week, efficient and tolerable, low-intensity exercise program with NMES-VC for improving quadriceps strength, knee pain and physical function in women with risk factors for incident symptomatic or progressive KOA. This specific aim will be achieved through a randomized, controlled trial, comparing low intensity exercise with and without NMES-VC. This research is novel in that it will be the first to use a low load regimen that will minimize the potential for adverse loading on the knee joint while still having a high likelihood to lead to clinically meaningful strength gains, pain relief and physical function improvement in older adults at elevated risk for symptomatic or progressive KOA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hybrid Training | Experimental | Device: Hybrid Training using Electrodes and Joint Motion SensorsThe hybrid training system combines the applications of neuromuscular electrical stimulation (NMES) with voluntary contractions (NMES-VC). Training will be performed in a seated position with feet not touching the ground, and will involve each knee flexing and extending alternately. The joint range of motion will be restricted to a 90º arc from approximately 10º to 100º of flexion. Each session will consist of 5 sets of 10 repetitions, 3-second knee flexion and extension contractions on each leg. Sets will be separated by 30-sec rest intervals. Electrodes will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and over the medial and lateral hamstrings on the posterior thigh. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group. |
| Low Intensity Exercise | Active comparator | Device: Isokinetic Training with Isokinetic Dynamometer40% 1-repetition maximum isokinetic training with HUMAC NORM in same repetitions/sets as experimental group. |
Who may qualify
- Ages
- 40 to 85 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Female
- Age 40-85 years
- One or more of the following:
- BMI less than 45 kg/m2
Key exclusion criteria (23 listed)
- Knee injection within 6 weeks prior to the study
- Resistance training at any time in the last 3 months prior to the study
- Bilateral knee replacement
- Lower limb amputation
- Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
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 |
|---|---|---|
| Hybrid Training using Electrodes and Joint Motion SensorsElectrodes (Sekisui Plastics Co., Tokyo, Japan) will be placed on the anterior thigh over the motor points of the bilateral vastus medialis and lateralis, and on the posterior thigh over the motor points of the medial and lateral hamstrings. Electrical stimulation intensity will be set to approximately 40% of 1 repetition maximum (RM). A joint motion sensor (Mutoh Engineering Inc., Tokyo, Japan) will trigger stimulation of the antagonist once it senses the initiation of volitional contraction of the agonist muscle group. | Device | Hybrid Training |
| Isokinetic Training with Isokinetic DynamometerAlso: Resistance TrainingLow intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM. | Device | Low Intensity Exercise |
Primary outcome
Change in Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer.
Time frame: Baseline and 12-week follow-up
Participants will be familiarized with strength testing equipment and counseled on proper lifting technique. They will undergo testing to determine their peak isokinetic knee extensor torque at 60°/sec, using an isokinetic dynamometer. These testing procedures will then be repeated for the other side.
4 secondary outcomes
Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer.
Time frame: Baseline and 12-week follow-up
Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score
Time frame: Baseline and 12-week follow-up
Change in 20-meter Walk Time
Time frame: Baseline and 12-week follow-up
Change in 5-chair Stand Time
Time frame: Baseline and 12-week follow-up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19407734Centers for Disease Control and Prevention (CDC). Prevalence and most common causes of disability among adults--United States, 2005. MMWR Morb Mortal Wkly Rep. 2009 May 1;58(16):421-6.
- Background: PubMed 17013996Dillon CF, Rasch EK, Gu Q, Hirsch R. Prevalence of knee osteoarthritis in the United States: arthritis data from the Third National Health and Nutrition Examination Survey 1991-94. J Rheumatol. 2006 Nov;33(11):2271-9. Epub 2006 Oct 1.
- Background: PubMed 20351594Segal NA, Glass NA, Felson DT, Hurley M, Yang M, Nevitt M, Lewis CE, Torner JC. Effect of quadriceps strength and proprioception on risk for knee osteoarthritis. Med Sci Sports Exerc. 2010 Nov;42(11):2081-8. doi: 10.1249/MSS.0b013e3181dd902e.
- Background: PubMed 19714608Segal NA, Torner JC, Felson D, Niu J, Sharma L, Lewis CE, Nevitt M. Effect of thigh strength on incident radiographic and symptomatic knee osteoarthritis in a longitudinal cohort. Arthritis Rheum. 2009 Sep 15;61(9):1210-7. doi: 10.1002/art.24541.
- Background: PubMed 17013827van Dijk GM, Dekker J, Veenhof C, van den Ende CH; Carpa Study Group. Course of functional status and pain in osteoarthritis of the hip or knee: a systematic review of the literature. Arthritis Rheum. 2006 Oct 15;55(5):779-85. doi: 10.1002/art.22244.
- Background: PubMed 8484690McAlindon TE, Cooper C, Kirwan JR, Dieppe PA. Determinants of disability in osteoarthritis of the knee. Ann Rheum Dis. 1993 Apr;52(4):258-62. doi: 10.1136/ard.52.4.258.
- Background: PubMed 15491837Palmieri RM, Tom JA, Edwards JE, Weltman A, Saliba EN, Mistry DJ, Ingersoll CD. Arthrogenic muscle response induced by an experimental knee joint effusion is mediated by pre- and post-synaptic spinal mechanisms. J Electromyogr Kinesiol. 2004 Dec;14(6):631-40. doi: 10.1016/j.jelekin.2004.06.002.
- Background: PubMed 16502299Heroux ME, Tremblay F. Corticomotor excitability associated with unilateral knee dysfunction secondary to anterior cruciate ligament injury. Knee Surg Sports Traumatol Arthrosc. 2006 Sep;14(9):823-33. doi: 10.1007/s00167-006-0063-4. Epub 2006 Feb 25.
- Background: PubMed 14627927Palmieri RM, Ingersoll CD, Edwards JE, Hoffman MA, Stone MB, Babington JP, Cordova ML, Krause BA. Arthrogenic muscle inhibition is not present in the limb contralateral to a simulated knee joint effusion. Am J Phys Med Rehabil. 2003 Dec;82(12):910-6. doi: 10.1097/01.PHM.0000098045.04883.02.
- Background: PubMed 22135156Muraki S, Akune T, Oka H, Ishimoto Y, Nagata K, Yoshida M, Tokimura F, Nakamura K, Kawaguchi H, Yoshimura N. Incidence and risk factors for radiographic knee osteoarthritis and knee pain in Japanese men and women: a longitudinal population-based cohort study. Arthritis Rheum. 2012 May;64(5):1447-56. doi: 10.1002/art.33508.
- Background: PubMed 9230035Slemenda C, Brandt KD, Heilman DK, Mazzuca S, Braunstein EM, Katz BP, Wolinsky FD. Quadriceps weakness and osteoarthritis of the knee. Ann Intern Med. 1997 Jul 15;127(2):97-104. doi: 10.7326/0003-4819-127-2-199707150-00001.
- Background: PubMed 25300730Aguiar GC, Do Nascimento MR, De Miranda AS, Rocha NP, Teixeira AL, Scalzo PL. Effects of an exercise therapy protocol on inflammatory markers, perception of pain, and physical performance in individuals with knee osteoarthritis. Rheumatol Int. 2015 Mar;35(3):525-31. doi: 10.1007/s00296-014-3148-2. Epub 2014 Oct 10.
- 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.
Neil A Segal, MD principal investigator
University of Kansas Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hybrid Training using Electrodes and Joint Motion Sensors and Isokinetic Training with Isokinetic Dynamometer in people with Knee Osteoarthritis, run by University of Kansas Medical Center 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 7 inclusion and 23 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 18 May 2018. 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?
Yes. Results are posted in the registry (first posted 18 May 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Maximal Isokinetic Knee Extensor Torque by Body Mass Assessed by Isokinetic Dynamometer. (time frame: Baseline and 12-week follow-up). 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 NCT02802878, which also lists 37 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 18 May 2018.