- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05490966
Effects of Isometric Muscle Fatigue on Trunk Muscle Stiffness
October 18, 2022 updated by: MatejVoglar, University of Primorska
Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Single visit interventional study of the effects of a trunk extensor muscles fatigue protocol on multifidus and erector spinae muscle stiffness measured by Ultrasound based Shearwave elastography.
Study Type
Interventional
Enrollment (Actual)
22
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
-
-
-
Izola, 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: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Isometric fatigue
Fatiguing intermittent isometric exertions of trunk extensor muscles will be performed.
|
Participants will perform three sets of intermittent isometric efforts between 50 and 60 percents of their maximal isometric strength.
A padded force sensor will be placed approximately at the level of the 7th thoracic vertebrae.
The first two sets will last six minutes each, while the third set will last three minutes.
Between each set participants will rest for two minutes.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of trunk extensors muscle stiffness
Time Frame: 1 hour
|
Muscle stiffness will be measured at rest and during standardised sub-maximal exertions in prone lying position.
Muscle stiffness will be expressed as the shear modulus value in kilopascals.
|
1 hour
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change of muscle electromyography mean amplitude
Time Frame: 1 hour
|
Muscle activation of trunk extensors will be measured using superficial electromyography at rest and during two standardised sub-maximal exertions in prone lying position (single arm raise and upper body raise).
Mean amplitude in six to eight second time frames will be calculated.
|
1 hour
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in lumbar range of motion
Time Frame: 1 hour
|
Lumbar range of motion will be evaluated using Modified modified Schober test.
|
1 hour
|
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 10, 2022
Primary Completion (ACTUAL)
October 1, 2022
Study Completion (ACTUAL)
October 18, 2022
Study Registration Dates
First Submitted
August 4, 2022
First Submitted That Met QC Criteria
August 5, 2022
First Posted (ACTUAL)
August 8, 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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SWE_Isometric
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
Coded individual dat 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 Muscle Tightness
-
BTL Industries Ltd.Withdrawn
-
Riphah International UniversityRecruitingMuscle TightnessPakistan
-
Riphah International UniversityCompletedEffects of Foam Rolling Versus Stretching Exercises on Quadriceps, Hamstrings and Calf Muscle LengthMuscle TightnessPakistan
-
Riphah International UniversityCompleted
-
Riphah International UniversityRecruitingMuscle TightnessPakistan
-
Maharishi Markendeswar University (Deemed to be...Completed
-
Jeffrey SykoraCompleted
-
BTL Industries Ltd.WithdrawnMuscle TightnessUnited States, Bulgaria
-
Nationwide Children's HospitalCompletedMuscle TightnessUnited States
-
Marmara UniversityRecruitingRehabilitation | Muscle TightnessTurkey
Clinical Trials on isometric trunk extensor muscles fatigue
-
Shifa Tameer-e-Millat UniversityRecruiting
-
Gazi UniversityCompleted
-
Hacettepe UniversityCompleted
-
Riphah International UniversityCompletedBack Pain, LowPakistan
-
Rennes University HospitalRecruitingGait Disorder | Hemiparesis/Hemiplegia (One Sided Weakness/Paralysis)France
-
University of BelgradeTerminatedOsteoporosis | Electrical Stimulation | PostureSerbia
-
King Saud UniversityCompletedKnee OsteoarthritisSaudi Arabia
-
Gazi UniversityT.C. Dumlupınar ÜniversitesiCompletedRespiratory Muscles and Core StabilizationTurkey
-
Baskent UniversityCompleted
-
Joel TrinityNational Heart, Lung, and Blood Institute (NHLBI)RecruitingAging | Oxidative Stress | Skeletal Muscle | Vascular Endothelium | AntioxidantsUnited States