Effect of Exercise on Smokers | NCT06805968

Studies
Effect of Exercise on Smokers

NCT06805968

Sponsor

Istanbul Medipol University Hospital

Status

Completed

Last Update Posted

Feb 3, 2025Actual

Enrollment

30Actual

Phase

Not Applicable

Conditions

Smokers

Interventions

High Intensity Exercise + Placebo
Low Intensity Exercise + Placebo

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2023

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Sep 3, 2023Actual

Primary Completion Date

Dec 3, 2024Actual

Completion Date

Dec 3, 2024Actual

First Submitted Date

Jan 28, 2025

First Submission Date that Met QC Criteria

Jan 28, 2025

First Posted Date

Feb 3, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 28, 2025

Last Update Posted Date

Feb 3, 2025Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

ebrar atak, Asst. Prof., Istanbul Medipol University HospitalPrincipal Investigator

Lead Sponsor

Istanbul Medipol University HospitalOTHER

Collaborators

Name	Class
Istanbul Gedik University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

When we look at the literature, although 202 results are found when "high intensity training" AND "aerobic" is written in the PUBMED database, 27 to 86 results are found when "high intensity training" AND "cognitive" and "high intensity training" AND "respiratory" are written and searched. 5 results are found when "high intensity training" AND "smoking" is searched, but there is no study investigating cognitive and respiratory functions, and no results are found when "high intensity training" AND "smoker" is searched. As far as is known, there is no study investigating the acute effect of high intensity aerobic exercise on respiratory functions and cognitive status in special education personnel who smoke. We aim to contribute to the literature with this original aspect of our study.

Detailed Description

Primary objective: The primary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

Secondary objective: The secondary objective of the study is to investigate the acute effects of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.

Study questions

Is there an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke?
Is there an acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke?

Study Hypotheses:

H0: There is no acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

H1: There is an acute effect of high-intensity aerobic exercise on respiratory functions in special education personnel who smoke.

H2: There is no acute effect of high-intensity aerobic exercise on cognitive status in special education personnel who smoke.

H3: High-intensity aerobic exercise has an acute effect on cognitive status in special education personnel who smoke.

H4: High-intensity aerobic exercise has a greater acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.

H5: High-intensity aerobic exercise has a less acute effect on respiratory function and cognitive status in special education personnel who smoke than low-intensity training.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
high-intensity aerobic exercise group	Experimental		Other: High Intensity Exercise + Placebo
low-intensity aerobic exercise group	Active Comparator		Other: Low Intensity Exercise + Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
High Intensity Exercise + Placebo	Other	high intensity exercise	high-intensity aerobic exercise group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Smoking dependence level measurement	Meausered with Fagerström Nicotine Dependence Questionnaire (FNBA)	Duration of change in 1 day.
FVC Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.	Duration of change in 1 day.
FEV1 Measurement	Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated.	Duration of change in 1 day.

Secondary Outcomes

Measure	Description	Time Frame
Cognitive status measurement with MOCA	Measured with Montreal Cognitive Function Assessment Scale (MOCA)	Duration of change in 1 day.
Cognitive status measurement with Stroop Test	Measured with Stroop Test

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Volunteering to participate in the study
Participating in the Fageström Nicotine Dependence Questionnaire
No comorbidities
No comorbid diseases related to the orthopedic, neurological, cardiopulmonary system
Participants who have not participated in another clinical trial in the last month

Exclusion Criteria:

Participants who have had orthopedic and cardiopulmonary surgery in the last year
Those with cardiac or pulmonary system disease
Having sensory loss
Participants with leg length inequality

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Istanbul Gedik University		Istanbul			Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009043	Motor Activity

Ancestor Terms

ID	Term
D001519	Behavior

Browse Leaves

Not provided

Browse Branches

Not provided