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.
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
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.
- Conditions
- Muscle Fiber Atrophy, Type II
- 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 group | Role | What they receive |
|---|---|---|
| 1 | Experimental | The group who will get neuromuscular electrical stimulation (NMES) Receives: Other: Neuromuscular electrical stimulation |
| 2 | Active comparator | The 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.
Cross sectional area of type II muscle fibers
Measured: Base line and 3 months follow up
Secondary outcomes (3)
Quadriceps muscle power output
Measured: baseline and 3 month follow up
Functional performance
Measured: baseline and 3 month follow up
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.
- First posted3 Oct 2008 (estimated)
- Study startOct 2008
- Primary completionAug 2012
- Study completionAug 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Muscle Fiber Atrophy, Type IIStudies of the same condition, open and under way.
- More trials run by University of PittsburghThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University of Pittsburgh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00765739
- Acronym / sponsor ID
- NMES / NMES1
- Conditions
- Muscle Fiber Atrophy, Type II
- Keywords
- muscle fibers, aging
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University of PittsburghUniversity, hospital or other
- Study start
- Oct 2008
- Primary completion
- Aug 2012 (actual)
- Study completion
- Aug 2012 (actual)
- First posted
- 3 Oct 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Neuromuscular electrical stimulationThe group who will get neuromuscular electrical stimulation (NMES) |
| 2 | Active comparator | Other: voluntary strengthening exerciseThe group who will do the voluntary muscle contraction |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- 65-80 years old, are walking independently without assistive devices.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuromuscular electrical stimulationneuromuscular electrical stimulation that produce 40% of the maximum voluntary contraction | Other | 1 |
| voluntary strengthening exercisecontracting the quadriceps muscle voluntarily to produce 40% of maximum voluntary contraction | Other | 2 |
Primary outcome
Cross sectional area of type II muscle fibers
Time frame: Base line and 3 months follow up
3 secondary outcomes
Quadriceps muscle power output
Time frame: baseline and 3 month follow up
Functional performance
Time frame: baseline and 3 month follow up
Quadriceps muscle cross sectional area
Time frame: baseline and 3 month follow up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2013.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.