NCT05695742

Brief Summary

The study is a cross-sectional-descriptive study. Cases who met the inclusion criteria, agreed to participate in the study voluntarily, were active smokers, passive smokers and non-smokers will be included. The subjects will be given the maximal voluntary breath-hold test, the 6-minute walk test, and the 30-second sit-and-stand test, and will be asked to answer questions about smoking. The physical conditions of the groups will be compared.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
893

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

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

First Submitted

Initial submission to the registry

December 26, 2022

Completed
28 days until next milestone

Study Start

First participant enrolled

January 23, 2023

Completed
2 days until next milestone

First Posted

Study publicly available on registry

January 25, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 27, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 27, 2023

Completed
Last Updated

October 6, 2023

Status Verified

January 1, 2023

Enrollment Period

8 months

First QC Date

December 26, 2022

Last Update Submit

October 5, 2023

Conditions

Keywords

smokingactive smokingpasive smokingexercise capacitymaximal voluntary breath holdingFagerstrom

Outcome Measures

Primary Outcomes (2)

  • Six-minute walking test

    The subject will be asked to walk for 6 minutes on a flat surface of 30 meters and the distance covered will be recorded. The test will be performed in accordance with the American Thoracic Society guidelines

    1 day

  • Maximal voluntary breath-hold time

    The maximum voluntary breath-hold test is a quick and simple test that consists of measuring the apnea time after a deep inspiration. The clinical utility of this test has been proven in certain respiratory pathologies. In the test, the subject will be seated in a chair with back support, a deep inspiration will be asked, and the breath-holding time will be recorded in seconds. The test will be repeated three times with sufficient rest periods in between, and the longest time will be analyzed.

    1 day

Secondary Outcomes (3)

  • Thirty Seconds Sit and Stand test

    1 day

  • Fagerstrom Nicotine Addiction Test

    1 day

  • Evaluation scale of psychological dependence on cigarette

    1 day

Study Arms (3)

Active smokers

Having smoked at least 1 cigarette per day for at least 2 years.

Other: Active Smoking

Pasive smokers

Being exposed to secondhand smoke for more than 15 minutes at home, school, office or anywhere in the past year, once a week.

Other: Passive smoker

Non-smokers

Not being an active or passive smoker.

Other: Non-smoker

Interventions

Being active smoker

Active smokers

Being exposed to secondhand smoke

Pasive smokers

Not being an active or passive smoker.

Non-smokers

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Active, pasive smoker and non-smoker volunters

You may qualify if:

  • Being between the ages of 18-75
  • Smoking at least 1 cigarette a day for at least 2 years
  • Being between the ages of 18-75
  • Being exposed to cigarette smoke for more than 15 minutes at home, school, office or anywhere in the last year, once a week.
  • Being between the ages of 18-75
  • Not being an active or passive smoker

You may not qualify if:

  • Having any disease that prevents him from doing exercise tests
  • Not signing the voluntary informed consent form

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Esra Pehlivan

Istanbul, Üsküdar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Smoking CessationSmoking

Condition Hierarchy (Ancestors)

Health BehaviorBehavior

Study Officials

  • ESRA PEHLİVAN

    Saglik Bilimleri Universitesi

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 26, 2022

First Posted

January 25, 2023

Study Start

January 23, 2023

Primary Completion

September 27, 2023

Study Completion

September 27, 2023

Last Updated

October 6, 2023

Record last verified: 2023-01

Locations