- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06805968
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
Completed
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Actual)
30
Phase
- 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
-
-
-
Istanbul, Turkey (Türkiye)
- Istanbul Gedik University
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
Experimental: high-intensity aerobic exercise group
|
high intensity exercise
|
|
Active Comparator: low-intensity aerobic exercise group
|
low intensity exercise
|
What is the study measuring?
Primary Outcome Measures
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
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.
Collaborators
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)
September 3, 2023
Primary Completion (Actual)
December 3, 2024
Study Completion (Actual)
November 15, 2025
Study Registration Dates
First Submitted
January 28, 2025
First Submitted That Met QC Criteria
January 28, 2025
First Posted (Actual)
February 3, 2025
Study Record Updates
Last Update Posted (Actual)
July 17, 2026
Last Update Submitted That Met QC Criteria
July 16, 2026
Last Verified
July 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Smokers
-
Philip Morris Products S.A.CompletedSmokers | Never SmokersUnited States
-
Kaohsiung Veterans General Hospital.CompletedCurrent Smokers | Past Smokers | Never SmokersTaiwan
-
MTI UniversityCompleted
-
IRCCS San RaffaeleCompleted
-
A. Eden EvinsCompleted
-
Nikki Nollen, PhD, MACompleted
-
Memorial Sloan Kettering Cancer CenterNYU Langone Health; Ralph Lauren Center for Cancer Care and Prevention; Sophie... and other collaboratorsCompleted
-
Universitätsmedizin MannheimCompletedHealthy Subjects | Non-smokers | Smokers
Clinical Trials on High Intensity Exercise
-
Robert Ross, PhDRecruiting
-
Laboratoire des Adaptations Métaboliques à l'Exercice...CREPS Auvergne Rhône-Alpes / VichyCompletedOverweight | PostmenopausalFrance
-
National Institute of Neurological Disorders and...TerminatedTraumatic Brain InjuryUnited States
-
Cardiff Metropolitan UniversityCardiff UniversityCompletedPolycystic Ovary Syndrome | Exercise | Cerebrovascular CirculationUnited Kingdom
-
University of MiamiCompletedSedentary LifestyleUnited States
-
Universidade Federal do CearaCompletedDiabetes MellitusBrazil
-
University of Texas Southwestern Medical CenterAmerican Heart Association; Biotronik SE & Co. KG; American College of Sports...CompletedHypertrophic CardiomyopathyUnited States
-
Georgia State UniversityEmory UniversityWithdrawn
-
University of Alabama at BirminghamNational Heart, Lung, and Blood Institute (NHLBI)WithdrawnMyocardial Ischemia | Heart Diseases | Cardiovascular Diseases | Coronary Disease
-
University of AlbertaAlberta Diabetes InstituteCompletedExercise Intensity, Glycemic Control and Abdominal Fat in People With Type 2 Diabetes: A Pilot StudyType 2 Diabetes MellitusCanada