- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02122653
Evaluation and Training of Muscle Fitness in Pre-frail Individuals
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 Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Taoyuan, Taiwan, 333
- Chang Gung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Health subjects:
Exclusion Criteria:
Musculoskeletal injuries for knee. Osteoporosis. Diabetes.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Older WT
Older people with weight training
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Participants will perform 4 weeks of Weight training for lower extremities.
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Experimental: Older WT and ES
Older people with weight training combined electrical stimulation.
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Participants will perform 4 weeks of Weight training for lower extremities.
Participants will perform 4 weeks of electrical stimulation for Quadriceps muscle belly.
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No Intervention: Young control group
Young people with control group
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Muscle twitch force
Time Frame: Baseline, 4 weeks,8 weeks.
|
Measure of changes in muscle twitch force by interpolation twitch technique.
|
Baseline, 4 weeks,8 weeks.
|
Muscle voluntary activity level
Time Frame: Baseline, 4 weeks,8 weeks.
|
Measure of changes in muscle voluntary activity level by interpolation twitch technique.
|
Baseline, 4 weeks,8 weeks.
|
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.
|
Baseline, 4 weeks,8 weeks.
|
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.
|
Baseline, 4 weeks,8 weeks.
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 10044 (Registry Identifier: DAIDS-ES)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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