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

NCT02802878 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2018-05-18

Study results available
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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. 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)

Conditions

Interventions

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.

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.

Sponsors & Collaborators

  • Kurume University

    collaborator OTHER

  • University of Kansas Medical Center

    lead OTHER

Principal Investigators

  • Neil A Segal, MD · University of Kansas Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Max Age
85 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-06-30
Primary Completion
2016-12-14
Completion
2016-12-14

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02802878 on ClinicalTrials.gov