HealthyNCT06181071
Effectiveness of Distal and Proximal Muscle Fatigue for Healthy Young Adults
A study testing Distal Muscle Fatigue Protocol and Proximal Muscle Fatigue Protocol in people with Healthy and Young Adult, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
Trial summary
This is a study aiming to investigate the effects of acute muscle fatigue on muscle properties, balance and foot plantar pressure in healthy young adults (having no chronic diseases or orthopaedic diseases and physically active). Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy, Young Adult, Fatigue
- What is being tested?
- Distal Muscle Fatigue Protocol and Proximal Muscle Fatigue Protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2023to 18 Jan 2024
- 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 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- To be a healthy individual in the age range of 18-35,
- To be willing to participate in the study,
- To have a minimal active or highly active score on the International Physical Activity Questionnaire (Short Form),
- To have a body mass index (BMI) of 24.9 kg/m² or lower.
Who cannot join
- Having a history of injury and/or surgical operation related to the lower extremity,
- Having limited mobility in the lower extremity,
- Having any deformity related to the lower extremity,
- Having cardiovascular, vestibular, neurological, orthopedic, or skin-related diseases,
- Having any chronic disease that may affect balance,
- Having any acute/chronic musculoskeletal pain or systemic pain,
- Not to have given consent to participate in the study or to wish to withdraw from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
University of Health Sciences, Faculty of Health Sciences, Department of Physiotherapy and Rehabilitation Laboratory
Istanbul
About this study
Official title: Investigation of the Acute Effects of Distal and Proximal Muscle Fatigue on the Mechanical and Viscoelastic Properties of Lower Extremity, Foot Pressure Distribution, and Balance in Healthy Young Adults
This is a study aiming to investigate the effects of acute muscle fatigue on muscle properties, balance and foot plantar pressure in healthy young adults (having no chronic diseases or orthopaedic diseases and physically active). This study also aims to compare the effects of foot muscle fatigue and hip muscle fatigue on balance and foot plantar pressure.
The exercises for ankle muscle fatigue are heel rise with bending your knee and heel raise without bending your knees.
The exercise for hip muscle fatigue is a single-leg squat. Before and after completing these all exercises, the balance is evaluated with an isokinetic balance device, the foot plantar pressure is evaluated with a pedobarography device and finally, the muscle properties are evaluated with a myotonPro device. All assessment devices are non-invasive.
Read the detailed description
The International Physical Activity Questionnaire (Short form) will be used to assess individuals' physical activity levels. Prior to the distal and proximal fatigue protocols, the participants' maximum isometric muscle forces of the gastrocnemius, soleus, tibialis anterior, rectus femoris, and gluteus maximus muscles will be evaluated using a dynamometer.
Then, the mechanical and viscoelastic properties of these muscles and the iliotibial band will be assessed using the MyotonPro device, participants' static foot pressure on both feet will be evaluated through pedobarography, and individuals' dynamic balance and static balance will be evaluated on one foot using the Technobody isokinetic balance device.
The individuals included in the study will undergo exercises targeting the foot plantar flexor and dorsiflexor muscles on the first day, and exercises targeting the hip flexor and extensor muscles on the second day. The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer,
Heel raise exercises will be performed in 3 sets, with 30 seconds of free walking allowed for rest between sets. Individuals will initially complete 3 sets of this exercise without bending their knees. Then, they will perform the heel raise exercise with bent knees. The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer when the Modified Borg Scale indicates a level of 7 or above. If the muscle strength has decreased to 50% of the initial force, indicating fatigue, the exercise will be terminated.
Second day, a single-leg squat will be performed in 3 sets, with 30 seconds of free walking allowed for rest between sets.The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer when the Modified Borg Scale indicates a level of 7 or above. If the muscle strength has decreased to 50% of the initial force, indicating fatigue, the exercise will be terminated.
After the distal fatigue protocol, the viscoelastic properties of the gastrocnemius, soleus, and tibialis anterior muscles will be assessed using the MyotonPro device, while the plantar pressures will be evaluated through pedobarography. Additionally, static and dynamic balances will be measured using the Technobody device. Following the proximal fatigue protocol, the mechanical and viscoelastic properties of the gluteus maximus and rectus femoris muscles, along with the iliotibial band, will be examined using the MyotonPro device. Similarly, plantar pressures will be analyzed through pedobarography, and static and dynamic balances will be assessed using the Technobody device. The collected data will be recorded by the researcher.
- Conditions
- Healthy, Young Adult, Fatigue
- Being tested
- Distal Muscle Fatigue Protocol, Proximal Muscle Fatigue Protocol
- Keywords
- muscular fatigue, balance, elasticity, muscle tonus, foot plantar pressure
- Medical subject headings
- Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Distal Muscle Fatigue ProtocolOther
Initially, sociodemographic data, muscle viscoelastic properties, foot plantar pressure, and static and dynamic balance are assessed. Additionally, the strengths of the plantar flexor and dorsiflexor muscles are evaluated. After these assessments, the heel raise exercise will be implemented in this protocol. Firstly, dominant leg, the heel raise exercise will be performed for 3 sets with the knees in full extension until the individual reaches fatigue. Subsequently, the heel raise exercise will be conducted for another 3 sets with the knee in flexion until the individual reaches fatigue. Following these exercises, Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected.
Proximal Muscle Fatigue ProtocolOther
One week after the application of the distal muscle fatigue protocol, the same individuals will undergo the proximal fatigue protocol. In this protocol, individuals will perform, dominant leg, a single-leg squat exercise targeting the fatigue of the hip flexor and extensor muscles. Prior to this exercise, the viscoelastic properties of the muscles, foot plantar pressure, static and dynamic balances, as well as the strengths of the hip flexor and extensor muscles will be assessed. Then, individuals will perform the single-leg squat exercise, 3 sets. When the individual indicates fatigue, the set will conclude, allowing a 30-second rest between sets. Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected.
| Study group | Role | What they receive |
|---|---|---|
| Distal Fatigue of The Lower Extremity | Other | Distal muscle fatigue of the lower extremity involves the plantar and dorsiflexor muscles of the ankle. Receives: Other: Distal Muscle Fatigue Protocol; Other: Proximal Muscle Fatigue Protocol |
| Proximal Fatigue of The Lower Extremity | Other | Proximal muscle fatigue of the lower extremity involves hip flexor and extansor muscles. Receives: Other: Distal Muscle Fatigue Protocol; Other: Proximal Muscle Fatigue Protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myotonometric Assesment
Myotonometeric assessment is a non-invasive and novel method used to characterize the viscoelastic and biomechanical properties of muscles. The MyotonPro (Myoton Ltd, Myoton AS, Estonia) is an objective assessment tool that has been validated for inter-rater and intra-rater reliability, enabling the evaluation of mechanical and viscoelastic properties such as muscle tone, stiffness, and elasticity. The MyotonPro device is positioned perpendicular to the skin surface when the muscles are in a relaxed position. The device's probe applies an initial pressure of approximately 0.18 N to the skin surface, compressing the underlying tissue. Subsequently, a mechanical force of 0.4 N is applied for 15 ms to the compressed tissue beneath the skin.
Measured: Day 1 and Day 8
Isokinetic Balance Assesment
The TecnoBody Prokin PK 252 device, which is one of the objective methods used for the assessment of static and dynamic balance, allows the acquisition of numerical data at the end of the evaluation. Equipped with an isokinetic balance system, this device consists of a screen monitor and a sloped platform on which the individuals being evaluated stand. This platform has air pistons that provide a 15-degree tilt in all directions. These air pistons come into play, especially during the assessment of dynamic balance. The settings of the platform can be adjusted according to the evaluator's decision, thanks to the servo motors associated with the device.
Measured: Day 1 and Day 8
Secondary outcomes (1)
Foot Plantar Pressure Distribution Assesment
The analysis of foot plantar pressure distrubition is conducted using the objective and valid method of pedobarography. The Sensor Medica device, specifically the FreeStep v.1.0.3 88 software (Sensor Medica, Guidonia Montecelio, Rome, Italy), has been utilized for the analysis of pressure distributions. This device features a FreeMed Maxi Baropodometric Platform made of aluminum. The FreeStep software is employed for pressure analysis. Through this platform and the FreeStep software, foot plantar pressure distrubition can be assessed both statically and dynamically.
Measured: Day 1 and Day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Dec 2023
- Study start1 Dec 2023
- Primary completion10 Jan 2024
- Study completion18 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Saglik Bilimleri UniversitesiThe 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 N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gülenay Yıldırım, Saglik Bilimleri Universitesi
- Investigators
- Gulenay Yildirim, Principal investigator, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06181071
- Sponsor's protocol ID
- SaglikBilimleri22-114
- Status last verified
- Dec 2023
- First submitted
- 11 Dec 2023
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of the Acute Effects of Distal and Proximal Muscle Fatigue on the Mechanical and Viscoelastic Properties of Lower Extremity, Foot Pressure Distribution, and Balance in Healthy Young Adults
- ClinicalTrials.gov ID
- NCT06181071
- Acronym / sponsor ID
- SaglikBilimleri22-114
- Conditions
- Healthy, Young Adult, Fatigue
- Keywords
- muscular fatigue, balance, elasticity, muscle tonus, foot plantar pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Saglik Bilimleri UniversitesiUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Jan 2024 (actual)
- Study completion
- 18 Jan 2024 (actual)
- First posted
- 26 Dec 2023 (actual)
- 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.
This is a study aiming to investigate the effects of acute muscle fatigue on muscle properties, balance and foot plantar pressure in healthy young adults (having no chronic diseases or orthopaedic diseases and physically active). This study also aims to compare the effects of foot muscle fatigue and hip muscle fatigue on balance and foot plantar pressure.
The exercises for ankle muscle fatigue are heel rise with bending your knee and heel raise without bending your knees.
The exercise for hip muscle fatigue is a single-leg squat. Before and after completing these all exercises, the balance is evaluated with an isokinetic balance device, the foot plantar pressure is evaluated with a pedobarography device and finally, the muscle properties are evaluated with a myotonPro device. All assessment devices are non-invasive.
Detailed description
The International Physical Activity Questionnaire (Short form) will be used to assess individuals' physical activity levels. Prior to the distal and proximal fatigue protocols, the participants' maximum isometric muscle forces of the gastrocnemius, soleus, tibialis anterior, rectus femoris, and gluteus maximus muscles will be evaluated using a dynamometer.
Then, the mechanical and viscoelastic properties of these muscles and the iliotibial band will be assessed using the MyotonPro device, participants' static foot pressure on both feet will be evaluated through pedobarography, and individuals' dynamic balance and static balance will be evaluated on one foot using the Technobody isokinetic balance device.
The individuals included in the study will undergo exercises targeting the foot plantar flexor and dorsiflexor muscles on the first day, and exercises targeting the hip flexor and extensor muscles on the second day. The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer,
Heel raise exercises will be performed in 3 sets, with 30 seconds of free walking allowed for rest between sets. Individuals will initially complete 3 sets of this exercise without bending their knees. Then, they will perform the heel raise exercise with bent knees. The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer when the Modified Borg Scale indicates a level of 7 or above. If the muscle strength has decreased to 50% of the initial force, indicating fatigue, the exercise will be terminated.
Second day, a single-leg squat will be performed in 3 sets, with 30 seconds of free walking allowed for rest between sets.The researcher will measure the voluntary maximum isometric muscle strength using a dynamometer when the Modified Borg Scale indicates a level of 7 or above. If the muscle strength has decreased to 50% of the initial force, indicating fatigue, the exercise will be terminated.
After the distal fatigue protocol, the viscoelastic properties of the gastrocnemius, soleus, and tibialis anterior muscles will be assessed using the MyotonPro device, while the plantar pressures will be evaluated through pedobarography. Additionally, static and dynamic balances will be measured using the Technobody device. Following the proximal fatigue protocol, the mechanical and viscoelastic properties of the gluteus maximus and rectus femoris muscles, along with the iliotibial band, will be examined using the MyotonPro device. Similarly, plantar pressures will be analyzed through pedobarography, and static and dynamic balances will be assessed using the Technobody device. The collected data will be recorded by the researcher.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Distal Fatigue of The Lower Extremity | Other | Other: Distal Muscle Fatigue Protocol, Other: Proximal Muscle Fatigue ProtocolDistal muscle fatigue of the lower extremity involves the plantar and dorsiflexor muscles of the ankle. |
| Proximal Fatigue of The Lower Extremity | Other | Other: Distal Muscle Fatigue Protocol, Other: Proximal Muscle Fatigue ProtocolProximal muscle fatigue of the lower extremity involves hip flexor and extansor muscles. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- To be a healthy individual in the age range of 18-35,
- To be willing to participate in the study,
- To have a minimal active or highly active score on the International Physical Activity Questionnaire (Short Form),
- To have a body mass index (BMI) of 24.9 kg/m² or lower.
Key exclusion criteria (7 listed)
- Having a history of injury and/or surgical operation related to the lower extremity,
- Having limited mobility in the lower extremity,
- Having any deformity related to the lower extremity,
- Having cardiovascular, vestibular, neurological, orthopedic, or skin-related diseases,
- Having any chronic disease that may affect balance,
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 |
|---|---|---|
| Distal Muscle Fatigue ProtocolInitially, sociodemographic data, muscle viscoelastic properties, foot plantar pressure, and static and dynamic balance are assessed. Additionally, the strengths of the plantar flexor and dorsiflexor muscles are evaluated. After these assessments, the heel raise exercise will be implemented in this protocol. Firstly, dominant leg, the heel raise exercise will be performed for 3 sets with the knees in full extension until the individual reaches fatigue. Subsequently, the heel raise exercise will be conducted for another 3 sets with the knee in flexion until the individual reaches fatigue. Following these exercises, Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected. | Other | Distal Fatigue of The Lower Extremity, Proximal Fatigue of The Lower Extremity |
| Proximal Muscle Fatigue ProtocolOne week after the application of the distal muscle fatigue protocol, the same individuals will undergo the proximal fatigue protocol. In this protocol, individuals will perform, dominant leg, a single-leg squat exercise targeting the fatigue of the hip flexor and extensor muscles. Prior to this exercise, the viscoelastic properties of the muscles, foot plantar pressure, static and dynamic balances, as well as the strengths of the hip flexor and extensor muscles will be assessed. Then, individuals will perform the single-leg squat exercise, 3 sets. When the individual indicates fatigue, the set will conclude, allowing a 30-second rest between sets. Then, the strengths of the hip flexor and extensor muscles will be re-evaluated. If the individual reports a value of 7 or higher on the modified Borg scale, the viscoelastic properties of the muscles, foot plantar pressure, and static and dynamic balance will be reassessed when a 50% decrease in the initial strength is detected. | Other | Distal Fatigue of The Lower Extremity, Proximal Fatigue of The Lower Extremity |
Primary outcome
Myotonometric Assesment
Time frame: Day 1 and Day 8
Myotonometeric assessment is a non-invasive and novel method used to characterize the viscoelastic and biomechanical properties of muscles. The MyotonPro (Myoton Ltd, Myoton AS, Estonia) is an objective assessment tool that has been validated for inter-rater and intra-rater reliability, enabling the evaluation of mechanical and viscoelastic properties such as muscle tone, stiffness, and elasticity. The MyotonPro device is positioned perpendicular to the skin surface when the muscles are in a relaxed position. The device's probe applies an initial pressure of approximately 0.18 N to the skin surface, compressing the underlying tissue. Subsequently, a mechanical force of 0.4 N is applied for 15 ms to the compressed tissue beneath the skin.
Isokinetic Balance Assesment
Time frame: Day 1 and Day 8
The TecnoBody Prokin PK 252 device, which is one of the objective methods used for the assessment of static and dynamic balance, allows the acquisition of numerical data at the end of the evaluation. Equipped with an isokinetic balance system, this device consists of a screen monitor and a sloped platform on which the individuals being evaluated stand. This platform has air pistons that provide a 15-degree tilt in all directions. These air pistons come into play, especially during the assessment of dynamic balance. The settings of the platform can be adjusted according to the evaluator's decision, thanks to the servo motors associated with the device.
1 secondary outcome
Foot Plantar Pressure Distribution Assesment
Time frame: Day 1 and Day 8
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 22 Aug 2025.
- Individual participant dataSharing planned: No
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Gulenay Yildirim principal investigator
Saglik Bilimleri Universitesi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Distal Muscle Fatigue Protocol and Proximal Muscle Fatigue Protocol in people with Healthy and Young Adult, run by Saglik Bilimleri Universitesi at 1 site in Turkey (Türkiye).
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 4 inclusion and 7 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 22 Aug 2025. 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 Turkey (Türkiye). 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?
Myotonometric Assesment (time frame: Day 1 and Day 8). The study lists 2 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 22 Aug 2025.