AgingPhase 1NCT00059436
Mental Effort and Muscle Strength
A Phase 1 study testing Mental effort in muscle strengthening in people with Aging and Muscle Strength, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effect of mental effort on improving muscle strength. Read more about this study
- Who is it for?
- Ages 65 years and olderHealthy volunteers can take part
- Conditions the study is for
- Aging, Muscle Strength
- What is being tested?
- Mental effort in muscle strengthening
- Type of treatment
- Lifestyle or therapy programme
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Oct 1999to Sep 2004
- Phase
- Phase 1
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Older adult
Who may be able to join
- Healthy individuals free of neurological impairment
Who cannot join
- Already involved in regular physical training
- Neuromuscular disorders
- Medications known to affect neuromuscular system (other than moderate alcohol or caffeine)
- Left-hand dominant
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mental-effort Effect on Large Muscle Strengthening
The purpose of this study is to determine the effect of mental effort on improving muscle strength.
Read the detailed description
Training that involves heavy loads or resistance strengthens muscles. Recent data suggest that substantial voluntary strength gains can be achieved with training involving low resistance and strong mental effort. In contrast, individuals who train with the same low intensity contractions but with low mental effort show no improvement in strength.
This study will evaluate the relationship between mental effort muscle strength improvements by comparing the improvement in muscle strength in participants who have trained with different levels of mental effort. In addition to evaluating muscle strength, this study will also examine the neural mechanisms underlying muscle strength improvements.
Four groups of volunteers (65 years old and over) will participate in a training program directed at elbow-flexor muscles. One group will be trained with an intensity near the level of maximal voluntary contraction (MVC group); a second group will be trained with high mental effort, low muscle intensity contractions (HME group); a third group will be trained with low mental effort, low muscle intensity elbow-flexion contractions (LME group); and the fourth (control) group will not be trained but will participate in the strength tests. Training will be performed every weekday for 12 weeks. Participants will be evaluated by functional MRI (fMRI), EEG-derived motor activity-related cortical potential (MRCP), surface EMG signals, and the MRI T2 relaxation time.
Preliminary analysis of results shows that the HME group gained more than 13% strength, the LME group showed a statistically insignificant 6% change, and the no-practice control group did not show any change in elbow flexor muscle strength. We expect the MVC group to have the highest strength gains among the four groups.
- Conditions
- Aging, Muscle Strength
- Being tested
- Mental effort in muscle strengthening
- Keywords
- Muscle strengthening, Skeletal muscle Contractions, Rehabilitative exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mental effort in muscle strengtheningBehavioural
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2003 (estimated)
- Study startOct 1999
- Primary completionSep 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AgingStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Sponsor and investigators
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
- Sponsor type
- US National Institutes of Health
- Investigators
- Guang H. Yue, Ph.D., Principal investigator, Cleveland Clinic Foundation, Biomedical Engineering
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00059436
- Sponsor's protocol ID
- 1R01HD036725
- Status last verified
- May 2011
- First submitted
- 25 Apr 2003
- Last updated
- 26 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mental-effort Effect on Large Muscle Strengthening
- ClinicalTrials.gov ID
- NCT00059436
- Acronym / sponsor ID
- 1R01HD036725
- Conditions
- Aging, Muscle Strength
- Keywords
- Muscle strengthening, Skeletal muscle Contractions, Rehabilitative exercise
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)US National Institutes of Health
- Study start
- Oct 1999
- Primary completion
- Sep 2004 (actual)
- First posted
- 28 Apr 2003 (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 study is to determine the effect of mental effort on improving muscle strength.
Detailed description
Training that involves heavy loads or resistance strengthens muscles. Recent data suggest that substantial voluntary strength gains can be achieved with training involving low resistance and strong mental effort. In contrast, individuals who train with the same low intensity contractions but with low mental effort show no improvement in strength.
This study will evaluate the relationship between mental effort muscle strength improvements by comparing the improvement in muscle strength in participants who have trained with different levels of mental effort. In addition to evaluating muscle strength, this study will also examine the neural mechanisms underlying muscle strength improvements.
Four groups of volunteers (65 years old and over) will participate in a training program directed at elbow-flexor muscles. One group will be trained with an intensity near the level of maximal voluntary contraction (MVC group); a second group will be trained with high mental effort, low muscle intensity contractions (HME group); a third group will be trained with low mental effort, low muscle intensity elbow-flexion contractions (LME group); and the fourth (control) group will not be trained but will participate in the strength tests. Training will be performed every weekday for 12 weeks. Participants will be evaluated by functional MRI (fMRI), EEG-derived motor activity-related cortical potential (MRCP), surface EMG signals, and the MRI T2 relaxation time.
Preliminary analysis of results shows that the HME group gained more than 13% strength, the LME group showed a statistically insignificant 6% change, and the no-practice control group did not show any change in elbow flexor muscle strength. We expect the MVC group to have the highest strength gains among the four groups.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
Key inclusion criteria (1 listed)
- Healthy individuals free of neurological impairment
Key exclusion criteria (4 listed)
- Already involved in regular physical training
- Neuromuscular disorders
- Medications known to affect neuromuscular system (other than moderate alcohol or caffeine)
- Left-hand dominant
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 |
|---|---|---|
| Mental effort in muscle strengthening | Behavioural | – |
Primary outcome
Not reported in the source record.
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 26 Sep 2016.
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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.
Guang H. Yue, Ph.D. principal investigator
Cleveland Clinic Foundation, Biomedical Engineering
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mental effort in muscle strengthening in people with Aging and Muscle Strength, run by Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) 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 4 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 26 Sep 2016. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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.
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 26 Sep 2016.