NCT06805968

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2023

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 3, 2023

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 3, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 3, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 28, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 3, 2025

Completed
Last Updated

February 3, 2025

Status Verified

September 1, 2023

Enrollment Period

1.3 years

First QC Date

January 28, 2025

Last Update Submit

January 28, 2025

Conditions

Smokers

Keywords

smokeraerobicexercise

Outcome Measures

Primary Outcomes (3)

  • 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 (2)

  • Cognitive status measurement with MOCA

    Duration of change in 1 day.

  • Cognitive status measurement with Stroop Test

    Duration of change in 1 day.

Study Arms (2)

high-intensity aerobic exercise group

EXPERIMENTAL
Other: High Intensity Exercise + Placebo

low-intensity aerobic exercise group

ACTIVE COMPARATOR
Other: Low Intensity Exercise + Placebo

Interventions

High Intensity Exercise + PlaceboOTHER

high intensity exercise

high-intensity aerobic exercise group
Low Intensity Exercise + PlaceboOTHER

low intensity exercise

low-intensity aerobic exercise group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gedik University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof.

Study Record Dates

First Submitted

January 28, 2025

First Posted

February 3, 2025

Study Start

September 3, 2023

Primary Completion

December 3, 2024

Study Completion

December 3, 2024

Last Updated

February 3, 2025

Record last verified: 2023-09

Locations

TU(1)