Combined Application of Electrical Stimulation and Volitional Contractions for Muscle Strengthening and Knee Pain Inhibition (Seated Study)

April 17, 2018 updated by: Neil Segal, MD, MS, University of Kansas Medical Center

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:

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

42

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
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center

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

40 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  1. Female
  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:

  1. Knee injection within 6 weeks prior to the study
  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

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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.
Active Comparator: Low Intensity Exercise
40% 1-repetition maximum isokinetic training with HUMAC NORM in same repetitions/sets as experimental group.
Device: 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 Names:
  • Resistance Training

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and 12-week follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Maximal Isokinetic Knee Flexor 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 flexor torque, using an isokinetic dynamometer.
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
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.
Baseline and 12-week follow-up
Change in 20-meter Walk Time
Time Frame: Baseline and 12-week follow-up
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.
Baseline and 12-week follow-up
Change in 5-chair Stand Time
Time Frame: Baseline and 12-week follow-up
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.
Baseline and 12-week follow-up

Collaborators and Investigators

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

Sponsor

University of Kansas Medical Center

Collaborators

Kurume University

Investigators

  • Principal Investigator: Neil A Segal, MD, University of Kansas Medical Center

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

June 1, 2016

Primary Completion (Actual)

December 14, 2016

Study Completion (Actual)

December 14, 2016

Study Registration Dates

First Submitted

June 9, 2016

First Submitted That Met QC Criteria

June 13, 2016

First Posted (Estimate)

June 16, 2016

Study Record Updates

Last Update Posted (Actual)

May 18, 2018

Last Update Submitted That Met QC Criteria

April 17, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • STUDY00003872

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

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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