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The Effect of Neuromuscular Electrical Stimulation (NMES)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00765739
First received: October 2, 2008
Last updated: January 23, 2013
Last verified: January 2013
History of Changes
  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 Fiber Atrophy, Type II
 Other: Neuromuscular electrical stimulation
Other: voluntary strengthening exercise
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:

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

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 ]
Enrollment: 23
Study Start Date: October 2008
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Show Detailed Description

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00765739

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

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00765739     History of Changes
Other Study ID Numbers: NMES1
Study First Received: October 2, 2008
Last Updated: January 23, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
muscle fibers
aging

ClinicalTrials.gov processed this record on February 26, 2015