NCT05511896

Brief Summary

An interventional study on the effects of repeated trunk flexion exposure on trunk neuromuscular properties.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

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 19, 2022

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 23, 2022

Completed
9 days until next milestone

Study Start

First participant enrolled

September 1, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
14 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2022

Completed
Last Updated

October 19, 2022

Status Verified

October 1, 2022

Enrollment Period

1 month

First QC Date

August 19, 2022

Last Update Submit

October 18, 2022

Conditions

Keywords

bending, load, stiffness, elastography, deformation

Outcome Measures

Primary Outcomes (1)

  • Change in muscle stiffness

    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 Outcomes (3)

  • Change in range of motion

    90 minutes

  • Change in length of the spine

    90 minutes

  • Change in muscle activity

    90 minutes

Study Arms (1)

Intermittent trunk flexion

EXPERIMENTAL

60-min intermittent trunk flexion protocol.

Other: Repeated trunk flexion

Interventions

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.

Intermittent trunk flexion

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, Primorska, 6310, Slovenia

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

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 19, 2022

First Posted

August 23, 2022

Study Start

September 1, 2022

Primary Completion

October 1, 2022

Study Completion

October 15, 2022

Last Updated

October 19, 2022

Record last verified: 2022-10

Data Sharing

IPD Sharing
Will share

Coded individual data will be uploaded on public scientific data repository.

Shared Documents
STUDY PROTOCOL

Locations