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The Effect of Neuromuscular Electrical Stimulation (NMES) (NMES)

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ClinicalTrials.gov Identifier: NCT00765739
Recruitment Status : Completed
First Posted : October 3, 2008
Last Update Posted : January 24, 2013
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
The purpose of this project is to test the effectiveness of neuromuscular electrical stimulation (NMES) that produces 40 % of maximum voluntary contraction (MVC) in increasing muscle size and improvement in muscle force output within the thigh muscle of elderly people.

Condition or disease Intervention/treatment Phase
Muscle Fiber Atrophy, Type II Other: Neuromuscular electrical stimulation Other: voluntary strengthening exercise Phase 2

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Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 23 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Neuromuscular Electrical Stimulation (NMES) in Inducing Muscle Hypertrophy and Improvement in Muscle Torque Output Within the Quadriceps Muscle of Elderly People
Study Start Date : October 2008
Primary Completion Date : August 2012
Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dietary Fiber
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1
The group who will get neuromuscular electrical stimulation (NMES)
Other: Neuromuscular electrical stimulation
neuromuscular electrical stimulation that produce 40% of the maximum voluntary contraction
Active Comparator: 2
The group who will do the voluntary muscle contraction
Other: voluntary strengthening exercise
contracting the quadriceps muscle voluntarily to produce 40% of maximum voluntary contraction


Outcome Measures

Primary Outcome Measures :
  1. Cross sectional area of type II muscle fibers [ Time Frame: Base line and 3 months follow up ]

Secondary Outcome Measures :
  1. Quadriceps muscle power output [ Time Frame: baseline and 3 month follow up ]
  2. Functional performance [ Time Frame: baseline and 3 month follow up ]
  3. Quadriceps muscle cross sectional area [ Time Frame: baseline and 3 month follow up ]

Eligibility Criteria

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Ages Eligible for Study:   65 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 65-80 years old, are walking independently without assistive devices.

Exclusion Criteria:

  • Uncontrolled hypertension (defined as the following: 1) if not taking BP medication and resting systolic BP is greater than 140 or diastolic greater than 90, or 2) if taking BP medication and resting systolic BP greater than 160 or diastolic greater than 100).
  • History of cardiovascular disease
  • History of neurological disorders that effect lower extremity function (stroke, peripheral neuropathy, Parkinson's disease, multiple sclerosis)
  • One cortico-steroid injection to the quadriceps or patellar tendon in the past month or 3 within the past year.
  • History of quadriceps tendon rupture, patellar tendon rupture, or patellar fracture, which could place them at risk of re-injury during quadriceps strength testing.
  • Current pain in the knee or in the thigh muscles.
  • Diagnosis of inflammatory arthritis (Rheumatoid arthritis, gout, or psoriatic arthritis)
  • Muscle diseases such as muscular dystrophy.
  • Currently been participating in a regular exercise program more than 1x/week.
  • Been using anticoagulants and platelet inhibitors
  • History of chronic and significant respiratory disease or shortness of breath
  • Visual impairments to the extent that they can not accurately see the monitor screen during training program.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00765739


Locations
United States, Pennsylvania
School of Health and Rehabilitation Sciences
Pittsburgh, Pennsylvania, United States, 15260
Sponsors and Collaborators
University of Pittsburgh
More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00765739     History of Changes
Other Study ID Numbers: NMES1
First Posted: October 3, 2008    Key Record Dates
Last Update Posted: January 24, 2013
Last Verified: January 2013

Keywords provided by University of Pittsburgh:
muscle fibers
aging

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical