NCT05366959

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
201

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2022

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 15, 2022

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

May 5, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 5, 2022

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 10, 2022

Completed
Last Updated

May 10, 2022

Status Verified

May 1, 2022

Enrollment Period

3 months

First QC Date

May 5, 2022

Last Update Submit

May 5, 2022

Conditions

Keywords

Trunk muscle enduranceLow back painFatiguePhysical Activity

Outcome Measures

Primary Outcomes (6)

  • 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.

    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.

    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.

    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.

    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.

    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.

    0 (baseline)

Interventions

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 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.

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.

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.

Eligibility Criteria

Age18 Years - 24 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Our research is a cross-sectional study conducted on 201 healthy young adult university student volunteers aged 18-24.

You may qualify if:

  • Voluntarily agree to participate in the research

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ahi Evran University

Kırşehir, City Centre, 40100, Turkey (Türkiye)

Location

Related Publications (4)

  • .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
  • 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.

    PMID: 33775212BACKGROUND
  • Koumantakis 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.

    PMID: 34177201BACKGROUND
  • Abdelraouf 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.

    PMID: 27274419BACKGROUND

MeSH Terms

Conditions

Low Back PainFatigueMotor Activity

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Basak Cigdem Karacay, Asisst Prof

    Kirsehir Ahi Evran Universitesi

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 5, 2022

First Posted

May 10, 2022

Study Start

January 1, 2022

Primary Completion

April 15, 2022

Study Completion

May 5, 2022

Last Updated

May 10, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations