The Effect of Neuromuscular Electrical Stimulation (NMES) - Full Text View

Sponsored by:	University of Pittsburgh
Information provided by:	University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00765739

Purpose

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	Intervention	Phase
Muscle Fibers Atrophy in Elderly	Other: Neuromuscular electrical stimulation Other: voluntary strengthening exercise	Phase II

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind (Outcomes Assessor), Parallel Assignment
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

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:

Cross sectional area of type II muscle fibers [ Time Frame: Base line and 3 months follow up ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Quadriceps muscle power output [ Time Frame: baseline and 3 month follow up ] [ Designated as safety issue: No ]
Functional performance [ Time Frame: baseline and 3 month follow up ] [ Designated as safety issue: No ]
Quadriceps muscle cross sectional area [ Time Frame: baseline and 3 month follow up ] [ Designated as safety issue: No ]

Estimated Enrollment:	50
Study Start Date:	October 2008
Estimated Study Completion Date:	March 2010
Estimated Primary Completion Date:	October 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental The group who will get NMES	Other: Neuromuscular electrical stimulation neuromuscular electrical stimulation that produce 40% of the maximum voluntary contraction
2: Active Comparator 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

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Eligibility

Ages Eligible for Study:	65 Years to 80 Years
Genders Eligible for Study:	Both
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

No Contacts or Locations Provided

More Information

Responsible Party:	university of pittsburgh ( G. Kelley Fitzgerald, PT, PhD, OCS )
Study ID Numbers:	NMES1
Study First Received:	October 2, 2008
Last Updated:	October 2, 2008
ClinicalTrials.gov Identifier:	NCT00765739
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Pittsburgh:

muscle fibers
aging

Study placed in the following topic categories:

Pathological Conditions, Anatomical
Hypertrophy
Atrophy

ClinicalTrials.gov processed this record on January 13, 2009