NCT06805968

Brief Summary

Cigarette smoking is associated with adverse cardiovascular, respiratory, and cognitive effects. Acute aerobic exercise may influence cardiovascular workload, respiratory function, and cognitive performance; however, evidence comparing the immediate effects of different exercise intensities in people who smoke remains limited. This randomized controlled trial investigated the immediate effects of a single high-intensity versus low-intensity treadmill exercise session on rate-pressure product, spirometric outcomes, and cognitive performance in female healthcare professionals working in special education settings who smoke. The study provides information on the immediate cardiovascular, respiratory, and cognitive responses to different intensities of treadmill exercise in this population.

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

Typical duration for not_applicable

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
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
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2025

Completed
Last Updated

July 17, 2026

Status Verified

July 1, 2026

Enrollment Period

1.3 years

First QC Date

January 28, 2025

Last Update Submit

July 16, 2026

Conditions

Smokers

Keywords

smokeraerobicexercise

Outcome Measures

Primary Outcomes (1)

  • Rate-Pressure Product (RPP)

    Rate-pressure product (RPP) is calculated by multiplying heart rate (beats/min) by systolic blood pressure (mmHg) and dividing the result by 100. RPP provides an index of myocardial oxygen demand and cardiac workload. There is no fixed minimum or maximum value. Higher RPP values indicate greater myocardial workload and oxygen consumption.

    Duration of change in 1 day.

Secondary Outcomes (5)

  • The Fagerström Test for Nicotine Dependence (FTND)

    Duration of change in 1 day.

  • Cognitive status measurement with MOCA

    Duration of change in 1 day.

  • Cognitive status measurement with Stroop Test

    Duration of change in 1 day.

  • FEV1 Measurement

    Duration of change in 1 day.

  • FVC Measurement

    Duration of change in 1 day.

Study Arms (2)

high-intensity aerobic exercise group

EXPERIMENTAL
Other: High Intensity Exercise

low-intensity aerobic exercise group

ACTIVE COMPARATOR
Other: Low Intensity Exercise

Interventions

High Intensity ExerciseOTHER

high intensity exercise

high-intensity aerobic exercise group
Low Intensity ExerciseOTHER

low intensity exercise

low-intensity aerobic exercise group

Eligibility Criteria

Age18 Years - 50 Years
Sexall(Gender-based eligibility)
Gender Eligibility DetailsFemale healthcare professionals
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Current cigarette smoking, irrespective of nicotine dependence level
  • Voluntary agreement to participate in the study
  • Completion of the Fagerström Test for Nicotine Dependence
  • Absence of a known medical condition that would contraindicate treadmill exercise or interfere with cardiopulmonary assessment

You may not qualify if:

  • Diagnosed cardiac or pulmonary disease
  • Orthopedic, neurological, vestibular, or systemic disease that could affect exercise performance
  • Use of bronchodilator medication
  • Orthopedic or cardiopulmonary surgery within the preceding year
  • Pregnancy
  • Clinically relevant sensory loss
  • Leg-length discrepancy that could affect exercise performance
  • Participation in another clinical study during the preceding month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Istanbul Gedik University

Istanbul, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Motor Activity

Interventions

High-Intensity Interval Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Physical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

November 15, 2025

Last Updated

July 17, 2026

Record last verified: 2026-07

Locations

TU(1)