Lower-limb Muscle Mass and Balance PerformanceLMBPNCT07365605
Lower-Limb Muscle Mass and Balance Performance
An observational study of Lower-limb Muscle Mass and Balance Performance, run by Uludag University at 1 site in Turkey (Türkiye).
Trial summary
This study will examine the interaction between lower-limb muscle mass and balance performance in moderately physically active young men. Body composition parameters, including appendicular skeletal muscle mass, leg muscle mass, and the ratio of lower-limb muscle mass to body weight (LMM/BW), will be assessed using… Read more about this study
- Who is it for?
- Ages 20 to 32 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Lower-limb Muscle Mass and Balance Performance
- How many people
- 150 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Feb 2026to 3 Jun 2026
- Phase
- Observational
- 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 20 to 32 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Eskisehir, TURKEY
Who may be able to join
- Inclusion criteria required that participants (i) were between 20 and 30 years of age; (ii) had no lower-limb injuries that could affect test performance; (iii) were moderately physically active; and (iv) had not used ergogenic aids or stimulant substances for at least six months prior to the study.
Who cannot join
- Exclusion criteria included the presence of back, neck, leg, foot, or upper-limb pain within the previous six months, as well as a history of major orthopedic surgery involving the lower extremities or trunk.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Aeromedical Research And Training Center (ARTC)
Eskişehir
About this study
Official title: INTERACTION BETWEEN MUSCLE MASS AND BALANCE PERFORMANCE: A LOWER-LIMB-FOCUSED ANALYSIS
This study will examine the interaction between lower-limb muscle mass and balance performance in moderately physically active young men. Body composition parameters, including appendicular skeletal muscle mass, leg muscle mass, and the ratio of lower-limb muscle mass to body weight (LMM/BW), will be assessed using bioelectrical impedance analysis. Balance performance will be evaluated using a center-of-pressure-based static balance test, with classifications derived from sway path length and sway area parameters.
Participants will be grouped according to balance performance metrics, and muscle mass indicators will be compared between balance-based groups. Correlation analyses will also be conducted to explore associations between muscle mass variables and balance outcomes across the entire sample. It is anticipated that normalized muscle mass indicators, particularly LMM/BW, will demonstrate greater discriminative sensitivity than absolute muscle mass measures in relation to balance performance. The findings are expected to contribute to a more precise understanding of how relative lower-limb muscular capacity relates to postural control in young, physically active populations.
Read the detailed description
This study will employ a cross-sectional observational design to investigate the relationship between lower-limb muscle mass and balance performance in moderately physically active young men. The primary focus will be to determine whether normalized muscle mass indicators, particularly the ratio of lower-limb muscle mass to body weight (LMM/BW), demonstrate greater sensitivity in explaining balance-performance differences than absolute muscle mass measures.
A cohort of healthy male participants aged 20-30 years will be recruited. All participants will be moderately physically active and free from musculoskeletal injuries, neurological disorders, or medical conditions that could affect balance performance. After providing written informed consent, participants will undergo standardized anthropometric and body composition assessments using bioelectrical impedance analysis to obtain appendicular skeletal muscle mass, leg muscle mass, total muscle mass, body fat percentage, and LMM/BW.
Balance performance will be evaluated using a center-of-pressure-based static balance test performed on a stabilometric platform. Participants will complete a 30-second quiet standing task, during which sway path length and sway area will be recorded as primary balance outcomes. These parameters will be used to classify participants into balance-performance-based groups in order to examine the discriminative capacity of different balance metrics with respect to muscle mass variables.
Between-group comparisons of muscle mass indicators will be conducted to identify differences associated with balance performance classifications. In addition, correlation analyses will be performed across the entire sample to assess the strength and direction of associations between muscle mass variables and balance outcomes. Effect size estimates will be calculated to support the interpretation of observed differences.
The study is expected to clarify whether relative lower-limb muscular capacity provides a more functionally meaningful explanation of balance performance than absolute muscle mass in young, physically active populations. The findings may contribute to improved methodological approaches in balance assessment and support the use of normalized muscle mass indicators in sports science, exercise physiology, and preventive health contexts.
- Keywords
- Balance performance, Relative muscle mass, Lower-limb muscles, Postural stability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Lower Balance Performance Group (LBP) | This cohort will include moderately physically active young men who exhibit higher sway path length values during a 30-second center-of-pressure-based static balance test, indicating lower balance performance. Participants in this group will have no musculoskeletal, neurological, or medical conditions affecting postural control. This cohort will be used to examine muscle mass characteristics associated with relatively poorer balance performance. | |
| Higher Balance Performance Group (HBP) | This cohort will include moderately physically active young men who exhibit lower sway path length values during a 30-second center-of-pressure-based static balance test, indicating higher balance performance. Participants in this group will be free from conditions that may influence balance outcomes. This cohort will be used to evaluate muscle mass characteristics associated with relatively better balance performance. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Balance performance assessed by center-of-pressure sway path length
Balance performance will be quantified using center-of-pressure sway path length recorded during a 30-second quiet standing test on a stabilometric platform. Sway path length will represent the total displacement of the center of pressure over the trial duration, with higher values indicating poorer balance performance. This measure will serve as the primary balance outcome for group classification and for association analyses with lower-limb muscle mass indicators.
Measured: Day 1 (Assessed during a single laboratory testing session)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start26 Feb 2026
- Primary completion30 May 2026
- Study completion3 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Lower-limb Muscle Mass and Balance PerformanceStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uludag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ramiz ARABACI, Uludag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07365605
- Sponsor's protocol ID
- E-87914409-050.04-117156
- Acronym
- LMBP
- Status last verified
- Feb 2026
- First submitted
- 16 Jan 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study will use a cross-sectional observational design to examine the relationship between lower-limb muscle mass and balance performance in moderately physically active young men. Participants will complete standardized body composition assessments and a center-of-pressure-based static balance test during a single laboratory visit. Based on sway path length values, participants will be classified into lower and higher balance performance groups. Comparisons of muscle mass indicators, including absolute and normalized measures, will be conducted between balance-performance-based groups. In addition, associations between muscle mass variables and balance outcomes will be analyzed across the full sample to evaluate the relative explanatory value of different muscle mass indicators. The study plan is intended to determine whether normalized lower-limb muscle mass measures provide greater sensitivity for explaining balance performance differences than absolute muscle mass measures.
Publications
Lesinski M, Hortobagyi T, Muehlbauer T, Gollhofer A, Granacher U. Effects of Balance Training on Balance Performance in Healthy Older Adults: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1721-38. doi: 10.1007/s40279-015-0375-y.
PubMed 26325622Granacher, U., Gollhofer, A., & Hortobágyi, T. (2013). Effects of strength training on balance ability in older adults: A systematic review and meta-analysis. Sports Medicine, 43(6), 515-529. https://doi.org/10.1007/s40279-013-0045-y
Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
PubMed 30312372Calbet JA, Radegran G, Boushel R, Saltin B. On the mechanisms that limit oxygen uptake during exercise in acute and chronic hypoxia: role of muscle mass. J Physiol. 2009 Jan 15;587(2):477-90. doi: 10.1113/jphysiol.2008.162271. Epub 2008 Dec 1.
PubMed 19047206Bohannon RW, Bubela DJ, Magasi SR, Wang YC, Gershon RC. Sit-to-stand test: Performance and determinants across the age-span. Isokinet Exerc Sci. 2010;18(4):235-240. doi: 10.3233/IES-2010-0389.
PubMed 25598584
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INTERACTION BETWEEN MUSCLE MASS AND BALANCE PERFORMANCE: A LOWER-LIMB-FOCUSED ANALYSIS
- ClinicalTrials.gov ID
- NCT07365605
- Acronym / sponsor ID
- LMBP / E-87914409-050.04-117156
- Keywords
- Balance performance, Relative muscle mass, Lower-limb muscles, Postural stability
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Uludag UniversityUniversity, hospital or other
- Study start
- 26 Feb 2026 (actual)
- Primary completion
- 30 May 2026 (actual)
- Study completion
- 3 Jun 2026 (actual)
- First posted
- 26 Jan 2026 (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 study will examine the interaction between lower-limb muscle mass and balance performance in moderately physically active young men. Body composition parameters, including appendicular skeletal muscle mass, leg muscle mass, and the ratio of lower-limb muscle mass to body weight (LMM/BW), will be assessed using bioelectrical impedance analysis. Balance performance will be evaluated using a center-of-pressure-based static balance test, with classifications derived from sway path length and sway area parameters.
Participants will be grouped according to balance performance metrics, and muscle mass indicators will be compared between balance-based groups. Correlation analyses will also be conducted to explore associations between muscle mass variables and balance outcomes across the entire sample. It is anticipated that normalized muscle mass indicators, particularly LMM/BW, will demonstrate greater discriminative sensitivity than absolute muscle mass measures in relation to balance performance. The findings are expected to contribute to a more precise understanding of how relative lower-limb muscular capacity relates to postural control in young, physically active populations.
Detailed description
This study will employ a cross-sectional observational design to investigate the relationship between lower-limb muscle mass and balance performance in moderately physically active young men. The primary focus will be to determine whether normalized muscle mass indicators, particularly the ratio of lower-limb muscle mass to body weight (LMM/BW), demonstrate greater sensitivity in explaining balance-performance differences than absolute muscle mass measures.
A cohort of healthy male participants aged 20-30 years will be recruited. All participants will be moderately physically active and free from musculoskeletal injuries, neurological disorders, or medical conditions that could affect balance performance. After providing written informed consent, participants will undergo standardized anthropometric and body composition assessments using bioelectrical impedance analysis to obtain appendicular skeletal muscle mass, leg muscle mass, total muscle mass, body fat percentage, and LMM/BW.
Balance performance will be evaluated using a center-of-pressure-based static balance test performed on a stabilometric platform. Participants will complete a 30-second quiet standing task, during which sway path length and sway area will be recorded as primary balance outcomes. These parameters will be used to classify participants into balance-performance-based groups in order to examine the discriminative capacity of different balance metrics with respect to muscle mass variables.
Between-group comparisons of muscle mass indicators will be conducted to identify differences associated with balance performance classifications. In addition, correlation analyses will be performed across the entire sample to assess the strength and direction of associations between muscle mass variables and balance outcomes. Effect size estimates will be calculated to support the interpretation of observed differences.
The study is expected to clarify whether relative lower-limb muscular capacity provides a more functionally meaningful explanation of balance performance than absolute muscle mass in young, physically active populations. The findings may contribute to improved methodological approaches in balance assessment and support the use of normalized muscle mass indicators in sports science, exercise physiology, and preventive health contexts.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lower Balance Performance Group (LBP) | – | –This cohort will include moderately physically active young men who exhibit higher sway path length values during a 30-second center-of-pressure-based static balance test, indicating lower balance performance. Participants in this group will have no musculoskeletal, neurological, or medical conditions affecting postural control. This cohort will be used to examine muscle mass characteristics associated with relatively poorer balance performance. |
| Higher Balance Performance Group (HBP) | – | –This cohort will include moderately physically active young men who exhibit lower sway path length values during a 30-second center-of-pressure-based static balance test, indicating higher balance performance. Participants in this group will be free from conditions that may influence balance outcomes. This cohort will be used to evaluate muscle mass characteristics associated with relatively better balance performance. |
Who may qualify
- Ages
- 20 to 32 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Eskisehir, TURKEY
Key inclusion criteria (1 listed)
- Inclusion criteria required that participants (i) were between 20 and 30 years of age; (ii) had no lower-limb injuries that could affect test performance; (iii) were moderately physically active; and (iv) had not used ergogenic aids or stimulant substances for at least six months prior to the study.
Key exclusion criteria (1 listed)
- Exclusion criteria included the presence of back, neck, leg, foot, or upper-limb pain within the previous six months, as well as a history of major orthopedic surgery involving the lower extremities or trunk.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Balance performance assessed by center-of-pressure sway path length
Time frame: Day 1 (Assessed during a single laboratory testing session)
Balance performance will be quantified using center-of-pressure sway path length recorded during a 30-second quiet standing test on a stabilometric platform. Sway path length will represent the total displacement of the center of pressure over the trial duration, with higher values indicating poorer balance performance. This measure will serve as the primary balance outcome for group classification and for association analyses with lower-limb muscle mass indicators.
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 8 Jun 2026.
- Background: PubMed 26325622Lesinski M, Hortobagyi T, Muehlbauer T, Gollhofer A, Granacher U. Effects of Balance Training on Balance Performance in Healthy Older Adults: A Systematic Review and Meta-analysis. Sports Med. 2015 Dec;45(12):1721-38. doi: 10.1007/s40279-015-0375-y.
- BackgroundGranacher, U., Gollhofer, A., & Hortobágyi, T. (2013). Effects of strength training on balance ability in older adults: A systematic review and meta-analysis. Sports Medicine, 43(6), 515-529. https://doi.org/10.1007/s40279-013-0045-y
- Background: PubMed 30312372Cruz-Jentoft AJ, Bahat G, Bauer J, Boirie Y, Bruyere O, Cederholm T, Cooper C, Landi F, Rolland Y, Sayer AA, Schneider SM, Sieber CC, Topinkova E, Vandewoude M, Visser M, Zamboni M; Writing Group for the European Working Group on Sarcopenia in Older People 2 (EWGSOP2), and the Extended Group for EWGSOP2. Sarcopenia: revised European consensus on definition and diagnosis. Age Ageing. 2019 Jan 1;48(1):16-31. doi: 10.1093/ageing/afy169.
- Background: PubMed 19047206Calbet JA, Radegran G, Boushel R, Saltin B. On the mechanisms that limit oxygen uptake during exercise in acute and chronic hypoxia: role of muscle mass. J Physiol. 2009 Jan 15;587(2):477-90. doi: 10.1113/jphysiol.2008.162271. Epub 2008 Dec 1.
- Background: PubMed 25598584Bohannon RW, Bubela DJ, Magasi SR, Wang YC, Gershon RC. Sit-to-stand test: Performance and determinants across the age-span. Isokinet Exerc Sci. 2010;18(4):235-240. doi: 10.3233/IES-2010-0389.
- Individual participant dataSharing planned: No. This study will use a cross-sectional observational design to examine the relationship between lower-limb muscle mass and balance performance in moderately physically active young men. Participants will complete standardized body composition assessments and a center-of-pressure-based static balance test during a single laboratory visit. Based on sway path length values, participants will be classified into lower and higher balance performance groups. Comparisons of muscle mass indicators, including absolute and normalized measures, will be conducted between balance-performance-based groups. In addition, associations between muscle mass variables and balance outcomes will be analyzed across the full sample to evaluate the relative explanatory value of different muscle mass indicators. The study plan is intended to determine whether normalized lower-limb muscle mass measures provide greater sensitivity for explaining balance performance differences than absolute muscle mass measures.
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?
An observational study of Lower-limb Muscle Mass and Balance Performance, run by Uludag University 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 1 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 8 Jun 2026. 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?
Balance performance assessed by center-of-pressure sway path length (time frame: Day 1 (Assessed during a single laboratory testing session)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07365605, which also lists 5 linked publications.
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 8 Jun 2026.