Combined Application of Electrical Stimulation and Volitional Contractions for Muscle Strengthening and Knee Pain Inhibition (Seated Study)
NCT ID: NCT02802878
Last Updated: 2018-05-18
Study Results
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View full resultsBasic Information
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COMPLETED
NA
42 participants
INTERVENTIONAL
2016-06-30
2016-12-14
Brief Summary
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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:
1. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development
2. 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")
3. Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Hybrid Training
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.
Hybrid Training using Electrodes and Joint Motion Sensors
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.
Low Intensity Exercise
40% 1-repetition maximum isokinetic training with HUMAC NORM in same repetitions/sets as experimental group.
Isokinetic Training with Isokinetic Dynamometer
Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.
Interventions
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Hybrid Training using Electrodes and Joint Motion Sensors
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 Dynamometer
Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Age 40-85 years
3. One or more of the following:
1. 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
2. History of knee injury or surgery
3. Body Mass Index (BMI) greater than or equal to 25 kg/m2
4. BMI less than 45 kg/m2
Exclusion Criteria
2. Resistance training at any time in the last 3 months prior to the study
3. Bilateral knee replacement
4. Lower limb amputation
5. Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
6. Back, hip or knee problems that affect walking ability or ability to exercise
7. Unable to walk without a cane or walker
8. Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
9. Multiple sclerosis or other neurodegenerative disorder
10. Known neuropathy
11. Self-report of Diabetes
12. Currently being treated for cancer or having untreated cancer
13. Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
14. Peripheral Vascular Disease
15. History of myocardial infarction or stroke in the last year
16. Chest pain during exercise or at rest
17. Use of supplemental oxygen
18. Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
19. Staff concern for participant health (such as history of dizziness/faintness or current restrictions on activity)
20. Unable to attend 12 or more sessions during the study
21. Implanted cardiac pacemaker, spinal cord stimulator, baclofen or morphine pump or other implanted electrical device.
22. Dermatitis or skin sensitivity.
23. Pregnancy
40 Years
85 Years
FEMALE
No
Sponsors
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Kurume University
OTHER
University of Kansas Medical Center
OTHER
Responsible Party
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Neil Segal, MD, MS
Professor and Faculty Physiatrist
Principal Investigators
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Neil A Segal, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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University of Kansas Medical Center
Kansas City, Kansas, United States
Countries
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References
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Other Identifiers
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STUDY00003872
Identifier Type: -
Identifier Source: org_study_id
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