NCT06410638

Brief Summary

The aim of our study is to determine the effects of different exercise capacity tests on intercostal muscle oxygenation and to reveal the effect of changing accessory respiratory muscle oxygenation on exercise test success.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
32

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2024

Geographic Reach
1 country

1 active site

Status
recruiting

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

May 4, 2024

Completed
6 days until next milestone

Study Start

First participant enrolled

May 10, 2024

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 13, 2024

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2025

Completed
Last Updated

May 14, 2024

Status Verified

May 1, 2024

Enrollment Period

1.1 years

First QC Date

May 4, 2024

Last Update Submit

May 10, 2024

Conditions

Keywords

exercise capacity testmuscle oxygenationintercostal muscle

Outcome Measures

Primary Outcomes (1)

  • Evaluation of Muscle Oxygenation of intercostal muscles

    The measurement will be made with the MOXY device. The device will be placed on the intercostal muscle and measurements will be taken during the exercise tests. Measured values at the beginning, end and every 1 minute will be taken and analyzed.

    During intervention

Secondary Outcomes (5)

  • Forced expiratory pressure in one second

    Baseline

  • Evaluation of blood pressure

    During the intervention

  • Evaluation of heart rate

    During the intervention

  • Evaluation of oxygen saturation

    During the intervention

  • Forced vital capacity

    Baseline

Study Arms (1)

Healthy subjects

Diagnostic Test: Six Minute Walking TestDiagnostic Test: Shuttle walking test

Interventions

It is applied in a 30 m long corridor in an indoor environment, and the distance walked by the patient in a six-minute period, oxygen saturation, heart rate, and change in dyspnea are recorded. For this, before starting the test, oxygen saturation, heart rate, arterial blood pressure and dyspnea level according to the Borg scale are recorded. The same parameters are measured again at the end of the test. The feature of this test is that the person walks at his own pace, stopping when necessary and allowing the use of oxygen. It is an exercise test that is easy to perform and well tolerated.

Healthy subjects
Shuttle walking testDIAGNOSTIC_TEST

Shuttle walking test at increasing speed is an exercise test in which walk between two cones 10 m apart at an increasing speed throughout the test and each 10-meter journey between the two cones is counted as a shuttle.

Healthy subjects

Eligibility Criteria

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

Healthy young adults

You may qualify if:

  • Being between the ages of 18-35
  • Body Mass Index \<25 kg/m²
  • Participating in the study voluntarily

You may not qualify if:

  • Being a smoker
  • Presence of any systemic, orthopedic or cardiopulmonary disease that may prevent exercise tests
  • Presence of any diagnosed respiratory, vascular and heart disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Health Sciences Turkey

Istanbul, 34668, Turkey (Türkiye)

RECRUITING

Central Study Contacts

Eylem Cinkılıç

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assoc. Prof. Dr.

Study Record Dates

First Submitted

May 4, 2024

First Posted

May 13, 2024

Study Start

May 10, 2024

Primary Completion

June 1, 2025

Study Completion

June 1, 2025

Last Updated

May 14, 2024

Record last verified: 2024-05

Locations