NCT03699566

Brief Summary

The diaphragm forms the upper segment of the core structure. At the same time, the diaphragm muscle acts as the first muscle in the inspiratory function. The aim of this study was to investigate the relationship between respiratory functions and trunk muscle endurance. In this context, respiratory muscle strengths, respiratory functions and body muscle endurance of the cases were measured.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2017

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

March 10, 2017

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2017

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 5, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 9, 2018

Completed
Last Updated

October 9, 2018

Status Verified

October 1, 2018

Enrollment Period

3 months

First QC Date

October 5, 2018

Last Update Submit

October 5, 2018

Conditions

Keywords

Trunk muscle endurancerespiratory muscle strengthrespiratory functions

Outcome Measures

Primary Outcomes (2)

  • Maximal voluntary inspiratory (PImax)

    inspiratory pressure measurement in cm H2O

    Baseline assessment no follow- up

  • Prone Bridge Test

    Trunk endurance test aganist the time

    Baseline assessment no follow- up

Secondary Outcomes (6)

  • Maximal voluntary expiratory (PEmax)

    Baseline assessment no follow- up

  • Side Bride Test

    Baseline assessment no follow- up

  • Forced Vital Capacity ( FVC)

    Baseline assessment no follow- up

  • Forced Expiratuar Volume 1. Second ( Fev1)

    Baseline assessment no follow- up

  • Abdominal Flexor Endurance Test

    Baseline assessment no follow- up

  • +1 more secondary outcomes

Study Arms (1)

Healthy volunteers

Individuals aged 18-65 without chronic disease. Interventions: Assessment of Respiratory Muscle Strength, Spirometer, Trunk Muscles Endurance Tests

Other: Assessment of Respiratory Muscle StrengthOther: SpirometerOther: Trunk Muscles Endurance Tests

Interventions

The maximal voluntary inspiratory (PImax) and expiratory (PEmax) pressure measurements of the subjects were performed using Cosmed Pony FX model (Italy 2001) while the subjects were in the sitting position with a nose clip.

Healthy volunteers

Spirometric measurements were conducted with Cosmed, Pony FX (descopt spirometer- Italy 2001) spirometer using a nose clips while the subjects were in 90 degree relaxed sitting position.

Healthy volunteers

Trunk muscle endurance of the subjects was measured using four different tests (Side Bridge Test- SBT, Prone Bridge Test- PBT, Flexor Endurance Test- FET, Sorenson Test- ST).

Healthy volunteers

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Healthy volunteers

You may qualify if:

  • Not having any chronic disease
  • Not being pregnant

You may not qualify if:

  • History of cardiopulmonary disease.
  • Morbid obesity
  • Major surgical history

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gazi University

Ankara, Turkey (Türkiye)

Location

Study Officials

  • Nevin Güzel, prof. dr.

    Gazi University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research assistant

Study Record Dates

First Submitted

October 5, 2018

First Posted

October 9, 2018

Study Start

March 10, 2017

Primary Completion

June 15, 2017

Study Completion

August 15, 2017

Last Updated

October 9, 2018

Record last verified: 2018-10

Locations