NCT07027956

Brief Summary

This study aimed to compare respiratory function, exercise capacity, and intercostal muscle oxygenation in healthy smokers and non-smokers.

Trial Health

57
Monitor

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2025

Shorter than P25 for all trials

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 28, 2025

Completed
Same day until next milestone

Study Start

First participant enrolled

May 28, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

June 19, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2025

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2025

Completed
Last Updated

June 19, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 28, 2025

Last Update Submit

June 17, 2025

Conditions

Outcome Measures

Primary Outcomes (8)

  • Forced vital capacity

    Forced vital capacity (FVC) will be assessed using spirometry.

    1st day

  • Forced expiratory volume in one second

    Forced expiratory volume in one second (FEV1) will be assessed using spirometry

    1st day

  • Forced expiratory volume in one second/forced vital capacity ratio

    Forced expiratory volume in one second/forced vital capacity ratio will be assessed using spirometry.

    1st day

  • Peak expiratory flow

    Peak expiratory flow (PEF) will be assessed using spirometry.

    1st day

  • Forced mid-expiratory flow

    Forced mid-expiratory flow (FEF25-75) will be assessed using spirometry.

    1st day

  • Inspiratory muscle strength

    Strength index will be evaluated.

    1st day

  • Exercise capacity

    will be evaluated with 6 minute walk test and total distance will be recorded.

    2nd day

  • Intercostal muscle oxygenation

    During the 6-minute walking test, oxygenation of the intercostal muscles will be evaluated with a monitor.

    2nd day

Study Arms (2)

Smokers

Non-smokers

Eligibility Criteria

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

Individuals with smokers and non-smokers will be included in the study.

You may qualify if:

  • According to the World Health Organization and ICD smoking addiction criteria, consuming at least one cigarette every day for the last year
  • Volunteering to participate in research
  • Able to walk and cooperate

You may not qualify if:

  • Having any cardiopulmonary disease
  • Having a musculoskeletal problem that could affect the tests
  • Failure to comply with tests
  • According to the World Health Organization and ICD smoking addiction criteria, having never smoked or not having smoked in the last year
  • Volunteering to participate in research
  • Able to walk and cooperate
  • Having any cardiopulmonary disease
  • Having a musculoskeletal problem that could affect the tests
  • Failure to comply with tests

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kirsehir Ahi Evran University

Kırşehir, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Tobacco Smoking

Condition Hierarchy (Ancestors)

SmokingBehaviorTobacco Use

Central Study Contacts

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

May 28, 2025

First Posted

June 19, 2025

Study Start

May 28, 2025

Primary Completion

September 1, 2025

Study Completion

December 1, 2025

Last Updated

June 19, 2025

Record last verified: 2025-05

Locations