FatigueNCT02122653
Evaluation and Training of Muscle Fitness in Pre-frail Individuals
A study testing Weight training and Electronic muscle stimulator in people with Fatigue, run by Chang Gung University at 1 site in Taiwan.
Trial summary
Muscle strength and endurance are important indexes of fitness. The muscle strength is the most important single predict factor of functional ability in aged frail individuals. Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Fatigue
- What is being tested?
- Weight training and Electronic muscle stimulator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2012to Jul 2013
- Phase
- Interventional
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Musculoskeletal injuries for knee. Osteoporosis. Diabetes.
Trial locations and contacts
1 site in 1 country.
About this study
Muscle strength and endurance are important indexes of fitness. The muscle strength is the most important single predict factor of functional ability in aged frail individuals. Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the contributions of the central and the peripheral factors to the deficits of muscle fitness and developing an effective muscle fitness training program for pre-frail individuals are very important.
The muscle weakness and fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Studies found the selective type II fiber atrophy in aged people and this finding was different from the type I atrophy in conventional immobilization models. It is possible that the activation failure leads to the recruitment failure of high threshold type II fibers at the pre-frail stage. Quantifying the weighting of central versus peripheral factors contributing to the exercise limitation in pre-frail people is important.
Read more
Most of the conventional strength and endurance training programs are based on the researches of young groups. These programs are not able to prevent people become frail. It is possibly that, due to the limitation of central fatigue, the pre-frail individuals stop exercise before the effective intensity being achieved. Almost no training program has been design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation at the pre-frail stage is very important for preventing people become frail.
Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method to be used in training. Combining afferent input with strength training might be able to overcome the central activation failure and help recruit high threshold motor unit in pre-frail individuals.
- Conditions
- Fatigue
- Being tested
- Weight training, Electronic muscle stimulator
- Keywords
- Fatigue, aging, transcranial magnetic stimulation, interpolated, twitch technique
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Weight trainingOther
Participants will perform 4 weeks of Weight training for lower extremities.
Electronic muscle stimulatorDevice
Participants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly.
| Study group | Role | What they receive |
|---|---|---|
| Older WT | Experimental | Older people with weight training Receives: Other: Weight training |
| Older WT and ES | Experimental | Older people with weight training combined electrical stimulation. Receives: Other: Weight training; Device: Electronic muscle stimulator |
| Young control group | No intervention | Young people with control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Muscle twitch force
Measure of changes in muscle twitch force by interpolation twitch technique.
Measured: Baseline, 4 weeks,8 weeks.
Muscle voluntary activity level
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
Measured: Baseline, 4 weeks,8 weeks.
The central activation and the excitability of motor cortex
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
Measured: Baseline, 4 weeks,8 weeks.
Muscle strength test for lower extremities.
Measure of changes in muscle strength test for lower extremities by clinical test.
Measured: Baseline, 4 weeks,8 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2014 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FatigueStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ya-Ju Chang, Chang Gung University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02122653
- Sponsor's protocol ID
- 10044
- Status last verified
- Apr 2014
- First submitted
- 23 Apr 2014
- Last updated
- 24 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Training of Muscle Fitness in Pre-frail Individuals
- ClinicalTrials.gov ID
- NCT02122653
- Acronym / sponsor ID
- 10044
- Conditions
- Fatigue
- Keywords
- Fatigue, aging, transcranial magnetic stimulation, interpolated, twitch technique
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Chang Gung UniversityUniversity, hospital or other
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 24 Apr 2014 (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.
Muscle strength and endurance are important indexes of fitness. The muscle strength is the most important single predict factor of functional ability in aged frail individuals. Frailty related muscle weakness and fatigue are adapted from the pre-frail stage. Finding the contributions of the central and the peripheral factors to the deficits of muscle fitness and developing an effective muscle fitness training program for pre-frail individuals are very important.
The muscle weakness and fatigue can be categorized into peripheral or central causes. The central fatigue and voluntary activation failure originate from the decrease in motivation or the reduction of the conduction within corticospinal tracts. Long term activation failure and central fatigue will cause disuse of muscle and result in peripheral weakness and peripheral fatigue. Studies found the selective type II fiber atrophy in aged people and this finding was different from the type I atrophy in conventional immobilization models. It is possible that the activation failure leads to the recruitment failure of high threshold type II fibers at the pre-frail stage. Quantifying the weighting of central versus peripheral factors contributing to the exercise limitation in pre-frail people is important.
Most of the conventional strength and endurance training programs are based on the researches of young groups. These programs are not able to prevent people become frail. It is possibly that, due to the limitation of central fatigue, the pre-frail individuals stop exercise before the effective intensity being achieved. Almost no training program has been design for enhancing the voluntary activation level and relief the central fatigue. Seeking an appropriate training program to enhance central activation at the pre-frail stage is very important for preventing people become frail.
Previous studies have shown that increasing afferent input by peripheral electrical stimulation (ES) at sensory threshold enhanced the plasticity of contralateral primary sensory cortex, the excitability of corticospinal tracts, and the functional performance in young adults. ES, which is easy to quantify the dose of afferent input, is a feasible method to be used in training. Combining afferent input with strength training might be able to overcome the central activation failure and help recruit high threshold motor unit in pre-frail individuals.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Older WT | Experimental | Other: Weight trainingOlder people with weight training |
| Older WT and ES | Experimental | Other: Weight training, Device: Electronic muscle stimulatorOlder people with weight training combined electrical stimulation. |
| Young control group | No intervention | –Young people with control group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (1 listed)
- Musculoskeletal injuries for knee. Osteoporosis. Diabetes.
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 |
|---|---|---|
| Weight trainingParticipants will perform 4 weeks of Weight training for lower extremities. | Other | Older WT, Older WT and ES |
| Electronic muscle stimulatorParticipants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly. | Device | Older WT and ES |
Primary outcome
Muscle twitch force
Time frame: Baseline, 4 weeks,8 weeks.
Measure of changes in muscle twitch force by interpolation twitch technique.
Muscle voluntary activity level
Time frame: Baseline, 4 weeks,8 weeks.
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
The central activation and the excitability of motor cortex
Time frame: Baseline, 4 weeks,8 weeks.
Measure of changes in the central activation and the excitability of motor cortex by Transcranial magnetic stimulation.
Muscle strength test for lower extremities.
Time frame: Baseline, 4 weeks,8 weeks.
Measure of changes in muscle strength test for lower extremities by clinical test.
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 Apr 2014.
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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.
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 study testing Weight training and Electronic muscle stimulator in people with Fatigue, run by Chang Gung University at 1 site in Taiwan.
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 0 inclusion and 1 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 Apr 2014. 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 Taiwan. 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.
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?
Muscle twitch force (time frame: Baseline, 4 weeks,8 weeks.). The study lists 4 primary outcomes in all. 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 Apr 2014.