- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05511896
Effects of a 60-min Repeated Trunk Flexion Protocol on Trunk Neuromuscular Properties.
October 18, 2022 updated by: MatejVoglar, University of Primorska
Effects of Repeated Trunk Flexion on Trunk Neuromuscular Properties.
An interventional study on the effects of repeated trunk flexion exposure on trunk neuromuscular properties.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
An interventional study will include 16 healthy young adults.
All participants will complete a 60-min protocol of intermittent trunk flexion.
Measurements of trunk neuromuscular properties will be performed prior to and following the 60-min protocol.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Primorska
-
Izola, Primorska, Slovenia, 6310
- University of Primorska, Faculty of Health Sciences
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 40 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Physically active at least 3 hours a week
Exclusion Criteria:
- Low back pain in the past 6 months
- History of chronic low back pain
- History of spinal or pelvic operation
- Hypermobility, more than 4 points on Beighton scale
- Cardiovascular or systemic diseases
- Pregnancy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Intermittent trunk flexion
60-min intermittent trunk flexion protocol.
|
A 60-min intermittent trunk flexion protocol.
Participants will sit on a standard height sit, with their knees bent at approximately 90° with their hands crossed on their chest.
They will perform 40 sets of 60 s of maintaining a flexed position, interspersed with 30 s of rest.
Participants will achieve the flexed position by tilting the pelvis posteriorly and leaning forward.
During rest, participants will sit up straight without leaning on the support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in muscle stiffness
Time Frame: 90 minutes
|
Muscle stiffness will be measured in prone lying using ultrasound-based shear wave elastography.
Erector spinae and multifidus muscle stiffness will be expressed as the shear modulus value in kilopasquals.
|
90 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in range of motion
Time Frame: 90 minutes
|
Trunk flexion range of motion will be evaluated using inertial measuring units during bending in standing position.
|
90 minutes
|
Change in length of the spine
Time Frame: 90 minutes
|
The length of spine will be measured on a custom-developed stadiometer, with the participants in a seated position.
|
90 minutes
|
Change in muscle activity
Time Frame: 90 minutes
|
Muscle activity will be measured using electromyography during standing.
|
90 minutes
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
September 1, 2022
Primary Completion (Actual)
October 1, 2022
Study Completion (Actual)
October 15, 2022
Study Registration Dates
First Submitted
August 19, 2022
First Submitted That Met QC Criteria
August 19, 2022
First Posted (Actual)
August 23, 2022
Study Record Updates
Last Update Posted (Actual)
October 19, 2022
Last Update Submitted That Met QC Criteria
October 18, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- SWE_Flexion1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Coded individual data will be uploaded on public scientific data repository.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Occupational Exposure
-
Oslo University HospitalCompleted
-
Ohio State UniversityUniversity of Kansas Medical CenterCompletedOccupational ExposureUnited States
-
University of VirginiaCompletedOccupational ExposureUnited States
-
Cairo UniversityUnknown
-
Avinashilingam Deemed UniversityIndian Council of Medical ResearchUnknownOccupational ExposureIndia
-
Swiss Federal Institute of TechnologyAuxivo AGCompletedOccupational ExposureSwitzerland
-
Ege UniversityCompleted
-
Assiut UniversityUnknown
-
Istituti Clinici Scientifici Maugeri SpARecruiting
-
Centre Hospitalier Intercommunal CreteilCompletedOccupational ExposureFrance
Clinical Trials on Repeated trunk flexion
-
University of PrimorskaCompleted
-
Istanbul Bilgi UniversityNot yet recruiting
-
Istanbul UniversityNot yet recruiting
-
University of ValenciaCompleted
-
General Committee of Teaching Hospitals and Institutes...Cairo University; Taibah UniversityCompleted
-
Logan College of ChiropracticUnknown
-
Texas Tech University Health Sciences CenterCompleted
-
University of Toronto Orthopaedic Sports MedicineArthroscopy Association of North AmericaUnknownAnterior Cruciate Ligament InjuryCanada
-
Teachers College, Columbia UniversityColumbia UniversityRecruiting
-
Asan Medical CenterCompleted