NCT05237427

Brief Summary

The aim of this study is to determine the reference value ranges for healthy adults of the incremental threshold load test, which evaluates respiratory muscle endurance.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
112

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2020

Typical duration 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

September 1, 2020

Completed
1.4 years until next milestone

First Submitted

Initial submission to the registry

January 18, 2022

Completed
27 days until next milestone

First Posted

Study publicly available on registry

February 14, 2022

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2022

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 18, 2023

Completed
Last Updated

March 3, 2023

Status Verified

March 1, 2023

Enrollment Period

2.1 years

First QC Date

January 18, 2022

Last Update Submit

March 2, 2023

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Incremental threshold loading test.

    A measure of endurance of inspiratory muscles.

    15 minute

  • Maximal inspiratory pressure

    A measure of the strength of inspiratory muscles

    20 minute

Secondary Outcomes (4)

  • Pulmonary function test - Forced expiratory volume in 1 second (FEV1)

    5 minute

  • Pulmonary function test - Forced vital capacity (FVC)

    5 minute

  • Maximal voluntary ventilation (MVV)

    5 minute

  • International Physical Activity Questionnaire - Short Form

    5 minute

Other Outcomes (1)

  • Anthropometric assessment

    5 minute

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Healthy volunteers between the ages of 18-35

You may qualify if:

  • Being between the ages of 18-35
  • Not having any disease
  • Not exercising regularly
  • Not smoking

You may not qualify if:

  • Having a respiratory disease
  • Have heart disease
  • Have a neuromuscular disease
  • Have Scoliosis
  • Having had thoracic surgery
  • Having experienced the respiratory muscle endurance protocol before

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kutahya Health Sciences University

Kütahya, 43100, Turkey (Türkiye)

Location

Study Officials

  • Selda Gokcen

    Kutahya Health Sciences University

    PRINCIPAL INVESTIGATOR

  • Ozgen Aras

    Kutahya Health Sciences University

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

January 18, 2022

First Posted

February 14, 2022

Study Start

September 1, 2020

Primary Completion

September 30, 2022

Study Completion

January 18, 2023

Last Updated

March 3, 2023

Record last verified: 2023-03

Locations

TU(1)