RunnersNCT06269224
Examining Factors Influencing Thoracolumbar Mobility in Runners
An observational study of Runners and Mobility, run by Hacettepe University at 1 site in Turkey (Türkiye).
Trial summary
The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. Read more about this study
- Who is it for?
- Ages 30 to 45 years
- What is being tested?
- Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners.
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2022to 1 Jan 2024
- 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 30 to 45 years
- All sexes
- No healthy volunteers
- Adult
Study population: The participants were recreational runners who run between 20 to 50 km weekly. The first group consisted of 35 runners who had been running for the last two years (RTY) while the second group had 35 runners who had been running for the last six months (RSM). The third group was composed of 35 sedentary individuals identified using the Sedentary Behavior Questionnaire.
Who may be able to join
- The participants were within the age range of 30 to 45.
Who cannot join
- The history of lower extremity or lumbar-related surgery within the last year and a body mass index (BMI) exceeding the normal threshold of 24.5 kg/m².
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examining Factors Influencing Thoracolumbar Mobility in Amateur Runners and Sedentary Individuals
The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running.
Read the detailed description
Context: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. Objective: To compare the TL mobility of individuals at different running levels and sedentary individuals. Design: Cross-sectional. Participants: The first group consisted of 35 runners who had been running for the last two years (RTY) while the second group had 35 runners who had been running for the last six months (RSM). The third group had 35 sedentary individuals. Main Outcomes Measures: Sports-related and sociodemographic information was recorded. The Myoton device was used over the Latissimus Dorsi (LD) muscle on both dominant and nondominant sides to measure muscle tone (Hz), elasticity, and stiffness (N/m) values. Trunk flexibility and flexibility of lumbar extensor muscles were measured with tape measurement (cm). The trunk range of motion (ROM, ˚) was measured using goniometer. Thoracolumbar Fascia Length Test and Modified Schober Test were used for thoracolumbar (TLF) fascia flexibility. Analysis of variance was used for statistical analysis. SPSS version 17.0 was used for all statistical analyses. The primary outcome was defined as lumbar extensor tightness. Numeric data obtained from the subjects were presented as mean, standard deviation (mean±SD) and percentage (%). The primary outcome was defined as lumbar extensor tightness. The sample size for each group was calculated to be 30 with a power of 80% and a significance level of 0.05. Considering potential dropouts, 35 participants were included in each group. The groups were not homogenous. As a nonparametric test, the 'Kruskal-Wallis test' was employed for the three-group comparison. The Mann-Whitney U test was used for the two-group comparison. Statistical significance was set at P < .05.
- Conditions
- Runners, Mobility, Fascia, Range of Motion
- Being tested
- Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners.
- Keywords
- running, Latissimus Dorsi, Tone, Elasticity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners.Other
The Myoton device was used over the Latissimus Dorsi (LD) muscle on both dominant and nondominant sides to measure muscle tone (Hz), elasticity, and stiffness (N/m) values. Trunk flexibility and flexibility of lumbar extensor muscles were measured with tape measurement (cm). The trunk range of motion (ROM, ˚) was measured using goniometer. Thoracolumbar Fascia Length Test and Modified Schober Test were used for thoracolumbar (TLF) fascia flexibility. The weekly training distance (km), duration (h) and daily water consumption (lt) rates were recorded. The percentage of individuals experiencing lower extremity injuries and lower back pain within the RSM group was calculated.
| Study group | Role | What they receive |
|---|---|---|
| There are 3 groups. 2 groups consist of runners and 1 group consists of sedentary individuals. | Participants were recreational runners who run between 20 to 50 km weekly; one group consisted of 35 runners who had been RTY, the second group consisted of 35 runners who had been running for RSM; the third group was composed of 35 sedentary individuals identified using the Sedentary Behavior Questionnaire. Participants were within the age range of 30 to 45. Exclusion criteria encompassed a history of lower extremity or lumbar-related surgery within the last year and a body mass index (BMI) exceeding the normal threshold of 24.5 kg/m². Receives: Other: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myoton Assessment
The passive mechanical properties of the muscle (Tone, Stiffness, and Elasticity) were measured using the Myoton-3 myotonometer medical device (Myoton Ltd., Estonia, EU) (ICC: 0.80-0.93). The patients were positioned prone with a thin rolled towel placed under their foreheads and their arms in a 180˚ flexion position for a fifteen-minute period of rest. In our study, a point 5 cm below the lower tip of the scapula was identified along the imaginary line of the LD muscle. The probe was at a 90˚ angle to the skin. The measurements were repeated ten times at one-second intervals and the average values were recorded. These values were then calculated for dominant and nondominant sides.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2024
- Study start1 Sep 2022
- Primary completion1 Jan 2023
- Study completion1 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RunnersStudies of the same condition, open and under way.
- More trials run by Hacettepe UniversityThe 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
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hacettepe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kübra Sarıoğlu, Hacettepe University
- Investigators
- Hacettepe University, Study director, university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06269224
- Sponsor's protocol ID
- HU-FTR-KS-01
- Status last verified
- Feb 2024
- First submitted
- 11 Feb 2024
- Last updated
- 22 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: I don't study for a doctorate. I want the data to remain private. But I will share my results. I think it will be enough to give my opinion in the discussion part.
Study at a glance
From the registry record, last updated by the sponsor on 22 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examining Factors Influencing Thoracolumbar Mobility in Amateur Runners and Sedentary Individuals
- ClinicalTrials.gov ID
- NCT06269224
- Acronym / sponsor ID
- HU-FTR-KS-01
- Conditions
- Runners, Mobility, Fascia, Range of Motion
- Keywords
- running, Latissimus Dorsi, Tone, Elasticity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Hacettepe UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (actual)
- Primary completion
- 1 Jan 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 21 Feb 2024 (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.
The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running.
Detailed description
Context: The presence of to is thoracolumbar (TL) mobility a significant aspect in the context of running. Most of the factors may be related to certain kinematic parameters of the lumbopelvic-hip complex during running. Objective: To compare the TL mobility of individuals at different running levels and sedentary individuals. Design: Cross-sectional. Participants: The first group consisted of 35 runners who had been running for the last two years (RTY) while the second group had 35 runners who had been running for the last six months (RSM). The third group had 35 sedentary individuals. Main Outcomes Measures: Sports-related and sociodemographic information was recorded. The Myoton device was used over the Latissimus Dorsi (LD) muscle on both dominant and nondominant sides to measure muscle tone (Hz), elasticity, and stiffness (N/m) values. Trunk flexibility and flexibility of lumbar extensor muscles were measured with tape measurement (cm). The trunk range of motion (ROM, ˚) was measured using goniometer. Thoracolumbar Fascia Length Test and Modified Schober Test were used for thoracolumbar (TLF) fascia flexibility. Analysis of variance was used for statistical analysis. SPSS version 17.0 was used for all statistical analyses. The primary outcome was defined as lumbar extensor tightness. Numeric data obtained from the subjects were presented as mean, standard deviation (mean±SD) and percentage (%). The primary outcome was defined as lumbar extensor tightness. The sample size for each group was calculated to be 30 with a power of 80% and a significance level of 0.05. Considering potential dropouts, 35 participants were included in each group. The groups were not homogenous. As a nonparametric test, the 'Kruskal-Wallis test' was employed for the three-group comparison. The Mann-Whitney U test was used for the two-group comparison. Statistical significance was set at P < .05.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| There are 3 groups. 2 groups consist of runners and 1 group consists of sedentary individuals. | – | Other: Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners.Participants were recreational runners who run between 20 to 50 km weekly; one group consisted of 35 runners who had been RTY, the second group consisted of 35 runners who had been running for RSM; the third group was composed of 35 sedentary individuals identified using the Sedentary Behavior Questionnaire. Participants were within the age range of 30 to 45. Exclusion criteria encompassed a history of lower extremity or lumbar-related surgery within the last year and a body mass index (BMI) exceeding the normal threshold of 24.5 kg/m². |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- The participants were recreational runners who run between 20 to 50 km weekly. The first group consisted of 35 runners who had been running for the last two years (RTY) while the second group had 35 runners who had been running for the last six months (RSM). The third group was composed of 35 sedentary individuals identified using the Sedentary Behavior Questionnaire.
Key inclusion criteria (1 listed)
- The participants were within the age range of 30 to 45.
Key exclusion criteria (1 listed)
- The history of lower extremity or lumbar-related surgery within the last year and a body mass index (BMI) exceeding the normal threshold of 24.5 kg/m².
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 |
|---|---|---|
| Participants were recreational runners who run between 20 to 50 km weekly; each one has 35 runners.The Myoton device was used over the Latissimus Dorsi (LD) muscle on both dominant and nondominant sides to measure muscle tone (Hz), elasticity, and stiffness (N/m) values. Trunk flexibility and flexibility of lumbar extensor muscles were measured with tape measurement (cm). The trunk range of motion (ROM, ˚) was measured using goniometer. Thoracolumbar Fascia Length Test and Modified Schober Test were used for thoracolumbar (TLF) fascia flexibility. The weekly training distance (km), duration (h) and daily water consumption (lt) rates were recorded. The percentage of individuals experiencing lower extremity injuries and lower back pain within the RSM group was calculated. | Other | There are 3 groups. 2 groups consist of runners and 1 group consists of sedentary individuals. |
Primary outcome
Myoton Assessment
Time frame: 1 month
The passive mechanical properties of the muscle (Tone, Stiffness, and Elasticity) were measured using the Myoton-3 myotonometer medical device (Myoton Ltd., Estonia, EU) (ICC: 0.80-0.93). The patients were positioned prone with a thin rolled towel placed under their foreheads and their arms in a 180˚ flexion position for a fifteen-minute period of rest. In our study, a point 5 cm below the lower tip of the scapula was identified along the imaginary line of the LD muscle. The probe was at a 90˚ angle to the skin. The measurements were repeated ten times at one-second intervals and the average values were recorded. These values were then calculated for dominant and nondominant sides.
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 Feb 2024.
- Individual participant dataSharing planned: No. I don't study for a doctorate. I want the data to remain private. But I will share my results. I think it will be enough to give my opinion in the discussion part.
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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.
Hacettepe University study director
university
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 Runners and Mobility, run by Hacettepe 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 22 Feb 2024. 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?
Myoton Assessment (time frame: 1 month). 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 Feb 2024.