NCT05490966

Brief Summary

Interventional study of the effects of a trunk extensor muscles fatigue protocol on trunk extensors stiffness.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
22

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2022

Shorter than P25 for not_applicable

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 4, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 8, 2022

Completed
1 month until next milestone

Study Start

First participant enrolled

September 10, 2022

Completed
21 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 18, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

21 days

First QC Date

August 4, 2022

Last Update Submit

October 18, 2022

Conditions

Keywords

multifiduserector spinaemuscle stiffness

Outcome Measures

Primary Outcomes (1)

  • Change of trunk extensors muscle stiffness

    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 Outcomes (1)

  • Change of muscle electromyography mean amplitude

    1 hour

Other Outcomes (1)

  • Change in lumbar range of motion

    1 hour

Study Arms (1)

Isometric fatigue

EXPERIMENTAL

Fatiguing intermittent isometric exertions of trunk extensor muscles will be performed.

Other: isometric trunk extensor muscles fatigue

Interventions

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.

Isometric fatigue

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Physically active at least 3 hours a week

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Primorska, Faculty of Health Sciences

Izola, 6310, Slovenia

Location

Study Officials

  • Matej Voglar, PhD

    University of Primorska, Faculty of Health Sciences

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor, PhD

Study Record Dates

First Submitted

August 4, 2022

First Posted

August 8, 2022

Study Start

September 10, 2022

Primary Completion

October 1, 2022

Study Completion

October 18, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Coded individual dat will be uploaded on public scientific data repository

Shared Documents
STUDY PROTOCOL

Locations