Acute Exercise Intensity Responses in Women Who Smoke

July 16, 2026 updated by: ebrar atak, Istanbul Medipol University Hospital

High-Intensity Treadmill Exercise Elicits Greater Acute Cardiovascular Workload Without Detectable Respiratory or Cognitive Advantage in Female Healthcare Professionals Who Smoke: A Randomized Trial

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Primary Objective To compare the immediate effects of a single high-intensity versus low-intensity treadmill exercise session on cardiovascular workload, as assessed by the baseline-to-postexercise change in rate-pressure product, in female healthcare professionals working in special education settings who smoke. Secondary Objectives To compare the immediate effects of a single high-intensity versus low-intensity treadmill exercise session on spirometric outcomes, including forced vital capacity, forced expiratory volume in 1 second, the FEV₁/FVC ratio, and peak expiratory flow, in female healthcare professionals working in special education settings who smoke. To compare the immediate effects of a single high-intensity versus low-intensity treadmill exercise session on cognitive performance, as assessed using the Stroop Test and the Montreal Cognitive Assessment, in female healthcare professionals working in special education settings who smoke. Study Questions Did a single high-intensity treadmill exercise session produce a greater immediate rate-pressure-product response than a single low-intensity treadmill exercise session in female healthcare professionals working in special education settings who smoke? Did the immediate changes in spirometric outcomes differ between the high-intensity and low-intensity treadmill exercise groups? Did the immediate changes in Stroop Test and Montreal Cognitive Assessment scores differ between the high-intensity and low-intensity treadmill exercise groups? Study Hypothesis It was hypothesized that high-intensity treadmill exercise would elicit a greater immediate rate-pressure-product response and different acute respiratory and cognitive responses than low-intensity treadmill exercise in female healthcare professionals working in special education settings who smoke.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: high-intensity aerobic exercise group
Other: High Intensity Exercise
high intensity exercise
Active Comparator: low-intensity aerobic exercise group
Other: Low Intensity Exercise
low intensity exercise

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rate-Pressure Product (RPP)
Time Frame: Duration of change in 1 day.
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The Fagerström Test for Nicotine Dependence (FTND)
Time Frame: Duration of change in 1 day.
The Fagerström Test for Nicotine Dependence (FTND) is a 6-item questionnaire used to assess the level of nicotine dependence. Total scores range from 0 to 10, with higher scores indicating greater nicotine dependence.
Duration of change in 1 day.
Cognitive status measurement with MOCA
Time Frame: Duration of change in 1 day.
The Montreal Cognitive Assessment (MoCA) is a screening tool used to assess global cognitive function, including attention, executive function, memory, language, visuospatial ability, abstraction, calculation, and orientation. Total scores range from 0 to 30, with higher scores indicating better cognitive function.
Duration of change in 1 day.
Cognitive status measurement with Stroop Test
Time Frame: Duration of change in 1 day.
The Stroop Test assesses selective attention, cognitive flexibility, and inhibitory control. The primary outcome is the completion time (seconds) required to complete the interference condition. There is no fixed minimum or maximum value. Shorter completion times indicate better cognitive performance, whereas longer completion times indicate poorer cognitive performance.
Duration of change in 1 day.
FEV1 Measurement
Time Frame: Duration of change in 1 day.
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated. Forced Expiratory Volume in 1 Second (FEV₁) is measured using spirometry and represents the volume of air (liters) that can be forcibly exhaled during the first second of a forced expiration. There is no fixed minimum or maximum value. Higher FEV₁ values indicate better pulmonary function.
Duration of change in 1 day.
FVC Measurement
Time Frame: Duration of change in 1 day.
Respiratory Function Test. The COSMED microQuark spirometer used. Lung volume was evaluated. Forced Vital Capacity (FVC) is measured using spirometry and represents the total volume of air (liters) that can be forcibly exhaled after a maximal inspiration. There is no fixed minimum or maximum value. Higher FVC values indicate better pulmonary function.
Duration of change in 1 day.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Istanbul Medipol University Hospital

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Istanbul Gedik University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 3, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 3, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 28, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 3, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • E56365223-050.02.02.2023.13754

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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