- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07405060
Impacts and Mechanisms of Age and Muscle Fatigue on Postural Control and Force Control
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This study aims to investigate the effects of muscle fatigue on postural control and gait performance in healthy older adults (≥65 years) and young adults (20-40 years). Neuromuscular fatigue has been associated with postural instability, but its influence on gait and potential age-related differences remain unclear. Therefore, this study will compare fatigue-induced changes in motor performance between age groups and examine whether fatigue of the upper and lower extremities produces similar functional effects.
Healthy older adults and young adults will be recruited from the community. Eligible participants must be in good health, able to walk independently, demonstrate normal cognitive function, and provide informed consent. Individuals with neurological, cardiovascular, musculoskeletal, or other conditions that may affect motor performance will be excluded.
A repeated-measures design will be used. The study will involve two laboratory sessions separated by at least one week. Participants will undergo pre-test assessments, a fatiguing exercise protocol, and post-test assessments. Motor outcomes-including maximal voluntary isometric contraction, postural control, and gait performance-will be measured before and after the fatiguing exercises. Fatiguing exercises will consist of repeated cycles of maximal contractions with rest periods, while heart rate and perceived exertion are monitored to ensure safety. The protocol will terminate if exertion reaches a predefined threshold or heart rate exceeds the age-predicted maximum.
Surface electromyography and electrical stimulation will be used to assess neuromuscular function. Postural control will be evaluated using a force plate under multiple standing conditions, and gait parameters will be measured while participants walk at comfortable and fast speeds. Statistical analyses will use repeated-measures mixed-model ANOVAs to examine the effects of age group and fatigue on motor outcomes.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Chu-Ling Yen
- Phone Number: 3059 886-3-2118800
- Email: clyen@mail.cgu.edu.tw
Study Locations
-
-
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Taoyuan District, Taiwan
- Recruiting
- Chang Gung Memorial Hospital
-
Taoyuan District, Taiwan
- Recruiting
- Chang Gung University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- 20 to 40 years (young), and 60-85 years (old)
- walk independently
- able to follow commands (Mini Mental Status Exam (MMSE) scores greater than 21
- able and willing to provide informed consent.
Exclusion Criteria:
- pregnancy
- neurologic, psychiatric, cardiac, vascular, pulmonary, musculoskeletal, immune, integumentary disease or disorder which might influence this study
- any current loss of sensation in the arms, wrists, hands, fingers, hips, knees, ankles or toes
- any pain at the time of testing
- any restriction in range of motion of lower extremity.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
Healthy people
General healthy people aged 20-40 and 60-85 years.
|
We compare the young and the old groups
We compare the results before and after muscle fatigue
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Maximal force
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The maximal force of upper and lower extremity muscles
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Walking speed
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The time taken by participants to walk a standardized distance
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Step Length
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The linear distance between the two ankles, typically expressed in centimeter(cm).
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Cadence
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The number of steps taken per minute (SPM)
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Single Support Time
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The duration within the gait cycle when only one foot is in contact with the ground, typically measured in seconds or as a percentage of the total gait cycle.
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Double Support Time
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The portion of the gait cycle where both feet are in contact with the ground, indicating the transition phase between steps, expressed as a percentage of the gait cycle or in seconds.
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
Swing Time
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The portion of the gait cycle where the foot is not in contact with the ground, moving forward to the next step.
It is usually expressed as a percentage of the total gait cycle or in seconds.
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
COP Velocity in Balance Tasks
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The speed at which the COP moves, calculated over the duration of the balance task.
Higher velocities may reflect more dynamic balance adjustments or instability.
Unit:millimeter per second(mm/s)
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
|
COP Area in Balance Tasks
Time Frame: Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
The area covered by the COP trajectory during the balance task, providing an estimate of the sway envelope.
A larger area might indicate poorer balance control.
Unit:square millimeter(mm^2)
|
Baseline (pre-fatigue protocol) and immediately after the fatigue protocol
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Oxygenated hemoglobin
Time Frame: Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
Oxygenated hemoglobin is the amount of hemoglobin bound to oxygen, reflecting tissue oxygen availability.
It's expressed as the percentage.
|
Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
|
Total hemoglobin
Time Frame: Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
Total hemoglobin is the combined amount of oxygenated and deoxygenated hemoglobin, reflecting overall blood volume in the tissue.
|
Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
|
Deoxygenated hemoglobin
Time Frame: Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
Deoxygenated hemoglobin is the amount of hemoglobin not bound to oxygen, reflecting oxygen extraction by tissues.
It's expressed as the percentage.
|
Baseline (pre-fatigue protocol), during the fatigue protocol, and immediately after the fatigue protocol.
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Chu-Ling Yen, Chang Gung University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 202200723A3
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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