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Completed

NCT Number: NCT06805968

Acute Exercise Intensity Responses in Women Who Smoke

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.

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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Istanbul Gedik University

Istanbul, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High Intensity Exercise

Other

high intensity exercise

Low Intensity Exercise

Other

low intensity exercise

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Istanbul Medipol University Hospital

Other

Collaborators

  • Istanbul Gedik University

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2025
First posted
Feb 3, 2025
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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