NCT02061410

Brief Summary

The purpose of this study is to determine the effects of neuromuscular electrical stimulation (NMES) on neuromuscular and functional parameters in elderly with knee osteoarthritis. The hypothesis is that NAMES is able to strengthen the quadriceps muscle and to improve healthy status of elderly with knee osteoarthritis.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2006

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2008

Completed
5.3 years until next milestone

First Submitted

Initial submission to the registry

February 7, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 12, 2014

Completed
Last Updated

February 12, 2014

Status Verified

February 1, 2014

Enrollment Period

2.8 years

First QC Date

February 7, 2014

Last Update Submit

February 10, 2014

Conditions

Keywords

Elderly

Outcome Measures

Primary Outcomes (3)

  • Peak torque change

    Maximal isometric knee extensor torques were obtained on an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems). Participants were positioned on the dynamometer according to the manufacturer's recommendations. After a warm-up and a familiarization session, each subject executed three maximal isometric knee extensor contractions with the knee fixed at a flexion angle of 60o. Each contraction lasted for 5 s and a 2-min interval was observed between consecutive contractions.

    Baseline and 9th intervention week

  • Electromyographic activation change

    An eight channel EMG system (AMT-8, Bortec Biomedical Ltd., Canada) connected to a Windaq data acquisition system (Dataq Instruments Inc., USA) was used during the maximal isometric and concentric knee extensor contractions. EMG signals were obtained following the recommendations by Surface ElectroMyoGraphy for the Non-Invasive Assessment of Muscles with respect to skin preparation and electrode positioning. Passive bipolar electrodes (Meditrace - 100; Ag/AgCl; inter-electrode distance = 2.2 cm) were placed on the skin covering the rectus femoris, vastus lateralis and vastus medialis muscles. A reference electrode was placed on the medial surface of the tibia. EMG signals were digitized with a sampling frequency of 2000 Hz per channel with a 16 bits analogue-to-digital board DI-720 (Dataq Instruments Inc., USA) and stored for further analysis.

    Baseline and 9th intervention week

  • Muscle architecture change

    An ultrassound system (SSD 4000, 51 Hz, ALOKA Inc., Japan) with a linear array probe (60 mm, 7.5 MHz), was used to determine the thickness, fascicle length, and pennation angle of the vastus lateralis muscle. Ultrassound images were obtained at rest with the subject sitting on the chair of an isokinetic dynamometer (Biodex System 3; Biodex Medical Systems, Shirley, NY) with the hip and knee flexed at 85o and 90o, respectively. All images were captured in the sagittal plane of vastus lateralis (at midway between the lateral condyle of the femur and the greater trochanter). The ultrasound probe was positioned in the approximate direction of the vastus lateralis muscle fibers (long axis with respect to the limb).

    Baseline and 9th intervention week

Study Arms (1)

Neuromuscular Electrical Stimulation (NMES)

EXPERIMENTAL

The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.

Device: Neuromuscular Electrical Stimlation (NMES)

Interventions

The intervention was performed with subjects seated on a regular chair (hip and knee angles maintained at approximately 908), 3 times/week for a period of 8 weeks. NMES parameters included: rectangular biphasic symmetric current, pulse duration of 400 ms and stimulation frequency of 80 Hz.

Neuromuscular Electrical Stimulation (NMES)

Eligibility Criteria

Age50 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • women, minimum age of 50 years;
  • clinically diagnosed with knee OA;
  • no contraindications to execute maximal knee extension tests (e.g., cardiorespiratory complications);
  • no previous musculoskeletal or joint injuries besides knee OA;
  • no hip or knee surgery;
  • no neurological problems.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Exercise Research Laboratory, School of Physical Education, Federal University of Rio Grande do Sul

Porto Alegre, Rio Grande do Sul, Brazil

Location

MeSH Terms

Conditions

Osteoarthritis, Knee

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Study Officials

  • Marco A Vaz, PhD

    Federal University of Rio Grande do Sul

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

February 7, 2014

First Posted

February 12, 2014

Study Start

January 1, 2006

Primary Completion

November 1, 2008

Last Updated

February 12, 2014

Record last verified: 2014-02

Locations