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

NCT02802878 | Completed Results

• 1 other identifier: STUDY00003872
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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 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. 1.Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases quadriceps muscle rate of force development
2. 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. 3.Determine the extent to which NMES-VC-enhanced low-intensity resistance training increases physical function (20m walk, chair stand)

Conditions

Knee Osteoarthritis

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 12-week follow-up

Secondary Outcomes (4)

• Change in Maximal Isokinetic Knee Flexor Torque by Body Mass Assessed by Isokinetic Dynamometer.

  Baseline and 12-week follow-up

• Change in Knee Pain Assessed by a Knee Injury and Osteoarthritis Outcome Score

  Baseline and 12-week follow-up

• Change in 20-meter Walk Time

  Baseline and 12-week follow-up

• Change in 5-chair Stand Time

  Baseline and 12-week follow-up

Study Arms (2)

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.

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.

Device: Isokinetic Training with Isokinetic Dynamometer

Interventions

Hybrid Training using Electrodes and Joint Motion Sensors DEVICE

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.

Hybrid Training

Isokinetic Training with Isokinetic Dynamometer DEVICE

Low intensity exercises completed using isokinetic dynamometer (HUMAC NORM, Computer Sports Medicine Inc. (CSMi), Stoughton, MA) in isokinetic mode at approximately 40%1 RM.

Also known as: Resistance Training

Low Intensity Exercise

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• University of Kansas Medical Center: lead
• Kurume University: collaborator

Study Sites (1)

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Related Publications (37)

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MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Neil Segal
• Organization: University of Kansas Medical Center

segal-research@kumc.edu

913-945-8985

Study Officials

• Neil A Segal, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor and Faculty Physiatrist

Study Record Dates

• First Submitted: June 9, 2016
• First Posted: June 16, 2016
• Study Start: June 1, 2016
• Primary Completion: December 14, 2016
• Study Completion: December 14, 2016
• Last Updated: May 18, 2018
• Results First Posted: May 18, 2018

Record last verified: 2018-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)