HealthyNCT05366959
The Relationship Between Trunk Muscle Endurance and Physical Activity, Low Back Pain and Fatigue in Young Adults
An observational study of Healthy, run by Kirsehir Ahi Evran Universitesi at 1 site in Turkey (Türkiye).
Trial summary
The trunk is a kinetic link that facilitates the transmission of force and angular moments between the lower and upper extremities, provides proximal stability for distal mobility, and maintains balance by keeping the body weight within the support surface.While trunk muscle strength is important for maintaining daily… Read more about this study
- Who is it for?
- Ages 18 to 24 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Trunk Muscle Endurance test, Fatigue Severity Scale and Roland Moris Scale
- How many people
- 201 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2022to 5 May 2022
- 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 18 to 24 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Our research is a cross-sectional study conducted on 201 healthy young adult university student volunteers aged 18-24.
Who may be able to join
- -Voluntarily agree to participate in the research
Who cannot join
- History of musculoskeletal surgery in the last 1 year
- Diagnosis of lumbar disc herniation, spondylolisthesis, knee ligament and connective tissue damage
- Scoliosis
- Pregnancy
- Malignancy and inflammatory disease
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ahi Evran University
Kırşehir, City Centre, 40100
About this study
The trunk is a kinetic link that facilitates the transmission of force and angular moments between the lower and upper extremities, provides proximal stability for distal mobility, and maintains balance by keeping the body weight within the support surface.While trunk muscle strength is important for maintaining daily living activities, trunk muscle endurance plays an important role in preventing injuries by stabilizing the spine during long-term physical activity and sports activities (2).Decreased trunk muscle endurance can result in fatigue and low back pain. Low back pain is a major public health problem worldwide. In modern industrial society, the number of low back pain patients is increasing due to sedentary lifestyles, lack of exercise and working conditions.The lifetime prevalence of low back pain has been reported as 84%.80% of low back pain is nonspecific, that is, muscle weakness and ligament-related reasons for unknown reasons(3,4).Increasing the endurance of the waist muscles with exercise is used in the treatment of low back pain. From this point of view, while planning our study, we wanted to evaluate whether the decrease in trunk muscles is associated with low back pain and fatigue in young adults.
Read the detailed description
Our research will be carried out in healthy youngs adult volunteers between the ages of 18-24.It is a non-invasive cross-sectional observational study without a control group.
No device will be used.The following measurement and evaluation methods will be applied to all individuals who voluntarily agree to participate in the research.First, demographic data will be collected with the Patient Evaluation Form. For trunk endurance measurement, McGill Trunk Muscle Endurance Tests, Modified Biering-Sorensen test and Lateral bridge test will be used.These tests measure muscle strength in seconds with examination as described below and do not require a device.Fatigue severity scale and Roland Morris Disability Form will be filled to evaluate fatigue and lumbar network.Physical Activity level will be measured with the International Physical Activity Scale.
- Conditions
- Healthy
- Being tested
- Trunk Muscle Endurance test, Fatigue Severity Scale, Roland Moris Scale, Physical Activity Levels
- Keywords
- Trunk muscle endurance, Low back pain, Fatigue, Physical Activity
- Medical subject headings
- Low Back Pain, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trunk Muscle Endurance testOther
Trunk flexors endurance test: Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated and the time it maintains this position will be recorded in seconds.
Modified "Biering-Sorensen" test: With this test, the endurance of trunk extensors is evaluated. The subjects are positioned in the prone position with the pelvis, hips and knees on the bed. The subjects are asked to extend their upper body straight forward from the edge of the table and the time they maintain this position will be recorded in seconds.
Lateral bridge test: During the test, the subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position, and the time they held the position would be recorded in seconds. The test will be done on both sides.
Fatigue Severity ScaleOther
"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.
Roland Moris ScaleOther
The "Roland Moris Scale" will be used to evaluate the participants for low back pain assessment. The Roland Morris Inquiry Form was designed to evaluate the functional disability of the patient. The total score ranges from 0 (no disability) to 24 (severe disability). The higher the total score, the lower the patient's functionality. It is a questionnaire filled by the patient, which evaluates the functionality of 24 items questioning the patient's mobility, self-care and sleep status. Each item marked as 'Yes' is given 1 point, and answers marked as 'No' are given 0 points. Turkish validity and reliability was established.
Physical Activity LevelsOther
The physical activity level of the participants will be measured with the International Physical activity scale: MET values will be calculated according to this scale, which has Turkish validity and reliability.
What is being measured
The primary outcome is the main question the study is designed to answer.
Trunc Muscle endurance -Trunk flexors endurance test
Trunk flexors endurance test: Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated and the time it maintains this position will be recorded in seconds.
Measured: 0 (baseline)
Trunc Muscle endurance -Modified "Biering-Sorensen" test:
Modified "Biering-Sorensen" test: With this test, the endurance of trunk extensors is evaluated. The subjects are positioned in the prone position with the pelvis, hips and knees on the bed. The subjects are asked to extend their upper body straight forward from the edge of the table and the time they maintain this position will be recorded in seconds.
Measured: 0 (baseline)
Trunc Muscle endurance -Lateral bridge test.
Lateral bridge test: During the test, the subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position, and the time they held the position would be recorded in seconds. The test will be done on both sides.
Measured: 0 (baseline)
Roland Morris Scale
The "Roland Moris Scale" will be used to evaluate the participants for low back pain assessment. The Roland Morris Inquiry Form was designed to evaluate the functional disability of the patient. The total score ranges from 0 (no disability) to 24 (severe disability). The higher the total score, the lower the patient's functionality. It is a questionnaire filled by the patient, which evaluates the functionality of 24 items questioning the patient's mobility, self-care and sleep status. Each item marked as 'Yes' is given 1 point, and answers marked as 'No' are given 0 points. Turkish validity and reliability was established.
Measured: 0 (baseline)
Fatigue Severity Scale
"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.
Measured: 0 (baseline)
physical activity level
The physical activity level of the participants will be measured with the International Physical activity scale: MET values will be calculated according to this scale, which has Turkish validity and reliability.
Measured: 0 (baseline)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 May 2022
- Study start1 Jan 2022
- Primary completion15 Apr 2022
- Study completion5 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Kirsehir Ahi Evran 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kirsehir Ahi Evran Universitesi
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Basak Cigdem Karacay, Kirsehir Ahi Evran Universitesi
- Investigators
- Basak Cigdem Karacay, Asisst Prof, Study director, Kirsehir Ahi Evran Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05366959
- Sponsor's protocol ID
- 4
- Status last verified
- May 2022
- First submitted
- 5 May 2022
- Last updated
- 10 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
.Abaraogu UO, Ugwa WO. Selected anthropometrics, spinal posture, and trunk muscle endurance as correlated factors of static balance among adolescent and young adult males. Turk J Phys Med Rehab. 2016;1:9-15.
Martinez-Romero MT, Ayala F, Aparicio-Sarmiento A, De Ste Croix M, Sainz De Baranda P. Reliability of five trunk flexion and extension endurance field-based tests in high school-aged adolescents: ISQUIOS programme. J Sports Sci. 2021 Aug;39(16):1860-1872. doi: 10.1080/02640414.2021.1903706. Epub 2021 Mar 28.
PubMed 33775212Koumantakis GA, Malkotsis A, Pappas S, Manetta M, Anastopoulos T, Kakouris A, Kiourtsidakis E. Lumbopelvic sagittal standing posture associations with anthropometry, physical activity levels and trunk muscle endurance in healthy adults. Hong Kong Physiother J. 2021 Dec;41(2):127-137. doi: 10.1142/S1013702521500128. Epub 2021 May 4.
PubMed 34177201Abdelraouf OR, Abdel-Aziem AA. THE RELATIONSHIP BETWEEN CORE ENDURANCE AND BACK DYSFUNCTION IN COLLEGIATE MALE ATHLETES WITH AND WITHOUT NONSPECIFIC LOW BACK PAIN. Int J Sports Phys Ther. 2016 Jun;11(3):337-44.
PubMed 27274419
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Trunk Muscle Endurance and Physical Activity, Low Back Pain and Fatigue in Young Adults
- ClinicalTrials.gov ID
- NCT05366959
- Acronym / sponsor ID
- 4
- Conditions
- Healthy
- Keywords
- Trunk muscle endurance, Low back pain, Fatigue, Physical Activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Kirsehir Ahi Evran UniversitesiUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 5 May 2022 (actual)
- First posted
- 10 May 2022 (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 trunk is a kinetic link that facilitates the transmission of force and angular moments between the lower and upper extremities, provides proximal stability for distal mobility, and maintains balance by keeping the body weight within the support surface.While trunk muscle strength is important for maintaining daily living activities, trunk muscle endurance plays an important role in preventing injuries by stabilizing the spine during long-term physical activity and sports activities (2).Decreased trunk muscle endurance can result in fatigue and low back pain. Low back pain is a major public health problem worldwide. In modern industrial society, the number of low back pain patients is increasing due to sedentary lifestyles, lack of exercise and working conditions.The lifetime prevalence of low back pain has been reported as 84%.80% of low back pain is nonspecific, that is, muscle weakness and ligament-related reasons for unknown reasons(3,4).Increasing the endurance of the waist muscles with exercise is used in the treatment of low back pain. From this point of view, while planning our study, we wanted to evaluate whether the decrease in trunk muscles is associated with low back pain and fatigue in young adults.
Detailed description
Our research will be carried out in healthy youngs adult volunteers between the ages of 18-24.It is a non-invasive cross-sectional observational study without a control group.
No device will be used.The following measurement and evaluation methods will be applied to all individuals who voluntarily agree to participate in the research.First, demographic data will be collected with the Patient Evaluation Form. For trunk endurance measurement, McGill Trunk Muscle Endurance Tests, Modified Biering-Sorensen test and Lateral bridge test will be used.These tests measure muscle strength in seconds with examination as described below and do not require a device.Fatigue severity scale and Roland Morris Disability Form will be filled to evaluate fatigue and lumbar network.Physical Activity level will be measured with the International Physical Activity Scale.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 24 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Our research is a cross-sectional study conducted on 201 healthy young adult university student volunteers aged 18-24.
Key inclusion criteria (1 listed)
- -Voluntarily agree to participate in the research
Key exclusion criteria (5 listed)
- History of musculoskeletal surgery in the last 1 year
- Diagnosis of lumbar disc herniation, spondylolisthesis, knee ligament and connective tissue damage
- Scoliosis
- Pregnancy
- Malignancy and inflammatory disease
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 |
|---|---|---|
| Trunk Muscle Endurance testTrunk flexors endurance test: Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated and the time it maintains this position will be recorded in seconds. Modified "Biering-Sorensen" test: With this test, the endurance of trunk extensors is evaluated. The subjects are positioned in the prone position with the pelvis, hips and knees on the bed. The subjects are asked to extend their upper body straight forward from the edge of the table and the time they maintain this position will be recorded in seconds. Lateral bridge test: During the test, the subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position, and the time they held the position would be recorded in seconds. The test will be done on both sides. | Other | – |
| Fatigue Severity Scale"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established. | Other | – |
| Roland Moris ScaleThe "Roland Moris Scale" will be used to evaluate the participants for low back pain assessment. The Roland Morris Inquiry Form was designed to evaluate the functional disability of the patient. The total score ranges from 0 (no disability) to 24 (severe disability). The higher the total score, the lower the patient's functionality. It is a questionnaire filled by the patient, which evaluates the functionality of 24 items questioning the patient's mobility, self-care and sleep status. Each item marked as 'Yes' is given 1 point, and answers marked as 'No' are given 0 points. Turkish validity and reliability was established. | Other | – |
| Physical Activity LevelsThe physical activity level of the participants will be measured with the International Physical activity scale: MET values will be calculated according to this scale, which has Turkish validity and reliability. | Other | – |
Primary outcome
Trunc Muscle endurance -Trunk flexors endurance test
Time frame: 0 (baseline)
Trunk flexors endurance test: Participants will be positioned with trunk flexed to 60º, knees and hips to 90º flexion. The evaluator fixes the feet on the ground by supporting them from the toes. When the 60º trunk flexion is broken, the test will be terminated and the time it maintains this position will be recorded in seconds.
Trunc Muscle endurance -Modified "Biering-Sorensen" test:
Time frame: 0 (baseline)
Modified "Biering-Sorensen" test: With this test, the endurance of trunk extensors is evaluated. The subjects are positioned in the prone position with the pelvis, hips and knees on the bed. The subjects are asked to extend their upper body straight forward from the edge of the table and the time they maintain this position will be recorded in seconds.
Trunc Muscle endurance -Lateral bridge test.
Time frame: 0 (baseline)
Lateral bridge test: During the test, the subjects were asked to lie on their side, raise their bodies on their forearms and toes and maintain this position, and the time they held the position would be recorded in seconds. The test will be done on both sides.
Roland Morris Scale
Time frame: 0 (baseline)
The "Roland Moris Scale" will be used to evaluate the participants for low back pain assessment. The Roland Morris Inquiry Form was designed to evaluate the functional disability of the patient. The total score ranges from 0 (no disability) to 24 (severe disability). The higher the total score, the lower the patient's functionality. It is a questionnaire filled by the patient, which evaluates the functionality of 24 items questioning the patient's mobility, self-care and sleep status. Each item marked as 'Yes' is given 1 point, and answers marked as 'No' are given 0 points. Turkish validity and reliability was established.
Fatigue Severity Scale
Time frame: 0 (baseline)
"Fatigue Severity Scale" was used to evaluate the fatigue level of the participants. This scale consists of a 7-point Likert scale. 1 point means strongly disagree, 7 means strongly agree. High scores are associated with increased fatigue. Evaluates the effects of fatigue on physical function, motivation, family and social life. Turkish validity and reliability was established.
physical activity level
Time frame: 0 (baseline)
The physical activity level of the participants will be measured with the International Physical activity scale: MET values will be calculated according to this scale, which has Turkish validity and reliability.
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 10 May 2022.
- Background.Abaraogu UO, Ugwa WO. Selected anthropometrics, spinal posture, and trunk muscle endurance as correlated factors of static balance among adolescent and young adult males. Turk J Phys Med Rehab. 2016;1:9-15.
- Background: PubMed 33775212Martinez-Romero MT, Ayala F, Aparicio-Sarmiento A, De Ste Croix M, Sainz De Baranda P. Reliability of five trunk flexion and extension endurance field-based tests in high school-aged adolescents: ISQUIOS programme. J Sports Sci. 2021 Aug;39(16):1860-1872. doi: 10.1080/02640414.2021.1903706. Epub 2021 Mar 28.
- Background: PubMed 34177201Koumantakis GA, Malkotsis A, Pappas S, Manetta M, Anastopoulos T, Kakouris A, Kiourtsidakis E. Lumbopelvic sagittal standing posture associations with anthropometry, physical activity levels and trunk muscle endurance in healthy adults. Hong Kong Physiother J. 2021 Dec;41(2):127-137. doi: 10.1142/S1013702521500128. Epub 2021 May 4.
- Background: PubMed 27274419Abdelraouf OR, Abdel-Aziem AA. THE RELATIONSHIP BETWEEN CORE ENDURANCE AND BACK DYSFUNCTION IN COLLEGIATE MALE ATHLETES WITH AND WITHOUT NONSPECIFIC LOW BACK PAIN. Int J Sports Phys Ther. 2016 Jun;11(3):337-44.
- Individual participant dataSharing planned: No
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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.
Basak Cigdem Karacay, Asisst Prof study director
Kirsehir Ahi Evran Universitesi
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 Healthy, run by Kirsehir Ahi Evran 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 1 inclusion and 5 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 10 May 2022. 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?
Trunc Muscle endurance -Trunk flexors endurance test (time frame: 0 (baseline)). The study lists 6 primary outcomes in all. 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 NCT05366959, which also lists 4 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 10 May 2022.