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Muscle Fiber Atrophy, Type IIPhase 2NMESNCT00765739

The Effect of Neuromuscular Electrical Stimulation (NMES)

A Phase 2 study testing Neuromuscular electrical stimulation and voluntary strengthening exercise in people with Muscle Fiber Atrophy, Type II, run by University of Pittsburgh at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 to 80 yearsHealthy volunteers can take part
Conditions the study is for
Muscle Fiber Atrophy, Type II
What is being tested?
Neuromuscular electrical stimulation and voluntary strengthening exercise
Could I receive a placebo?
No, everyone receives an active treatment
How many people
23 participants
Where
1 siteUnited States
Study dates
Oct 2008to Aug 2012
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 to 80 years
  • All sexes
  • Healthy volunteers accepted
  • Older adult

Who may be able to join

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

Who cannot join

  • 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.
Show all 12Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • School of Health and Rehabilitation Sciences

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

About this study

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

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.

Read the detailed description

Declines in whole skeletal muscle strength and size are features commonly associated with aging. Aging reduces the number of fibers in the whole muscle, which explains the loss of muscle mass. Frontera et al studied muscle strength, cross sectional area, and contractile properties of skinned parts of single fibers of the quadriceps muscle. He found that the strength and the whole muscle cross sectional area of knee extensors were significantly higher in young men compared to old subjects, but there were no differences between old and young subjects when the whole muscle strength was adjusted to the whole muscle cross sectional area (specific tension). He also found that muscle fibers from young men were stronger than muscle fibers from old men expressing the same myosin heavy chain isoform even after adjusting for size. Therefore they concluded that abnormality in the quantity and/or function of the contractile or regulatory proteins could explain the reduction in the ability of muscle fibers to generate force.

Along with the loss of muscle fibers, atrophy of the fibers also has been attributed to the aging process. This atrophy has been found to be selective to type II muscle fibers. Lexel et al found in a study done on the cross sections of the whole vastus lateralis muscle from 20 men (19-84 years of age) that the mean Cross Sectional Area (CSA) of type II fibers from muscles of older individuals was on average 35 % smaller while the mean CSA of type I was approximately 6 % smaller than that of young individuals.

Aging and muscles Maintaining muscle strength and size with aging has become a significant issue for elderly trying to keep up independent living and good quality of life. Several studies on old men and women have proven the effectiveness of the resistance exercises in reversing sarcopenia related problems . However in order to increase the size of type II muscle fibers we need to apply high intensity exercises (80 % of 1 RM), or by applying low resistance exercise that is very intense and is done with a large number of repetitions.

The use of electrical stimulation is well documented to improve quadriceps femoris muscle torque output. Numerous experiments have been done to characterize the pattern of activation of muscle fibers during electrically stimulated muscle contraction, and the results show that the recruitment of motor units during electrically induced muscle contraction is non selective. In other words, both type I and II fibers may have equal chance of being recruited during electrically induced muscle contraction. It has been found that NMES is more likely to activate type II muscle fibers at relatively low force levels compared to voluntary exercise. If this is found to be true, then we may have an alternative intervention to improve muscle strength and muscle hypertrophy for elderly individuals who could not perform high intensity exercises to achieve these same benefits. This alternative approach might result in improved overall physical function for these individuals.

The quadriceps muscle has been proposed to be treated because there is significant relationship between quadriceps muscle strength and dynamic stability during chair rise and gait at preferred speed in functionally limited elderly individuals

Methods This study is a two group, repeated measures, randomized clinical trial. Baseline measurements of quadriceps muscle cross-sectional area, type II muscle fiber cross-sectional area, quadriceps power output, the timed up and go test, the SPPB, stair climbing test and ramp up power test will be obtained from subjects prior to the interventions. Following the baseline assessments subjects will be randomly assigned to either the NMES group or the comparable isometric strengthening exercise group. A set of sequentially numbered envelopes will be created and a document indicating the intervention assignment will be placed in the sequentially numbered envelopes. Upon completion of the baseline assessment, the study coordinator will take the next envelope in the sequence and open the envelope. The study coordinator will assign the subject to a group based on the randomized group assignment information obtained from the sealed envelop. During the intervention period of the study subjects will receive either NMES or isometric strengthening exercise 3 times a week for 12 weeks. Each session will last from 15-30 minutes. Post training outcome measures will be taken at the end of the 12 week intervention period.

Being tested
Neuromuscular electrical stimulation, voluntary strengthening exercise
Keywords
muscle fibers, aging

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Neuromuscular electrical stimulationOther

    neuromuscular electrical stimulation that produce 40% of the maximum voluntary contraction

  • voluntary strengthening exerciseOther

    contracting the quadriceps muscle voluntarily to produce 40% of maximum voluntary contraction

Study groups in NCT00765739
Study groupRoleWhat they receive
1ExperimentalThe group who will get neuromuscular electrical stimulation (NMES)
Receives: Other: Neuromuscular electrical stimulation
2Active comparatorThe group who will do the voluntary muscle contraction
Receives: Other: voluntary strengthening exercise

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cross sectional area of type II muscle fibers

    Measured: Base line and 3 months follow up

Secondary outcomes (3)
  1. Quadriceps muscle power output

    Measured: baseline and 3 month follow up

  2. Functional performance

    Measured: baseline and 3 month follow up

  3. Quadriceps muscle cross sectional area

    Measured: baseline and 3 month follow up

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Oct 2008 (estimated)
  2. Study startOct 2008
  3. Primary completionAug 2012
  4. Study completionAug 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
23 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00765739
Sponsor's protocol ID
NMES1
Acronym
NMES
Status last verified
Jan 2013
First submitted
2 Oct 2008
Last updated
24 Jan 2013
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Neuromuscular electrical stimulation and voluntary strengthening exercise in people with Muscle Fiber Atrophy, Type II, run by University of Pittsburgh at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Jan 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cross sectional area of type II muscle fibers (time frame: Base line and 3 months follow up). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2013.

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