SmokersNCT06805968
Acute Exercise Intensity Responses in Women Who Smoke
A study testing High Intensity Exercise and Low Intensity Exercise in people with Smokers, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Smokers
- What is being tested?
- High Intensity Exercise and Low Intensity Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Sep 2023to 15 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
Read the 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.
- Conditions
- Smokers
- Being tested
- High Intensity Exercise, Low Intensity Exercise
- Keywords
- smoker, aerobic, exercise
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Intensity ExerciseOther
high intensity exercise
Low Intensity ExerciseOther
low intensity exercise
| Study group | Role | What they receive |
|---|---|---|
| high-intensity aerobic exercise group | Experimental | Not described Receives: Other: High Intensity Exercise |
| low-intensity aerobic exercise group | Active comparator | Not described Receives: Other: Low Intensity Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Duration of change in 1 day.
Secondary outcomes (5)
The Fagerström Test for Nicotine Dependence (FTND)
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.
Measured: Duration of change in 1 day.
Cognitive status measurement with MOCA
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.
Measured: Duration of change in 1 day.
Cognitive status measurement with Stroop Test
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.
Measured: Duration of change in 1 day.
FEV1 Measurement
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.
Measured: Duration of change in 1 day.
FVC Measurement
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.
Measured: Duration of change in 1 day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2025
- Study start3 Sep 2023
- Primary completion3 Dec 2024
- Study completion15 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Istanbul Gedik University
- Responsible party
- Principal investigator, ebrar atak, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06805968
- Sponsor's protocol ID
- E56365223-050.02.02.2023.13754
- Status last verified
- Jul 2026
- First submitted
- 28 Jan 2025
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT06805968
- Acronym / sponsor ID
- E56365223-050.02.02.2023.13754
- Conditions
- Smokers
- Keywords
- smoker, aerobic, exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Collaborators
- Istanbul Gedik University
- Study start
- 3 Sep 2023 (actual)
- Primary completion
- 3 Dec 2024 (actual)
- Study completion
- 15 Nov 2025 (actual)
- First posted
- 3 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| high-intensity aerobic exercise group | Experimental | Other: High Intensity Exercise |
| low-intensity aerobic exercise group | Active comparator | Other: Low Intensity Exercise |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High Intensity Exercisehigh intensity exercise | Other | high-intensity aerobic exercise group |
| Low Intensity Exerciselow intensity exercise | Other | low-intensity aerobic exercise group |
Primary outcome
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.
5 secondary outcomes
The Fagerström Test for Nicotine Dependence (FTND)
Time frame: Duration of change in 1 day.
Cognitive status measurement with MOCA
Time frame: Duration of change in 1 day.
Cognitive status measurement with Stroop Test
Time frame: Duration of change in 1 day.
FEV1 Measurement
Time frame: Duration of change in 1 day.
FVC Measurement
Time frame: Duration of change in 1 day.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High Intensity Exercise and Low Intensity Exercise in people with Smokers, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate-Pressure Product (RPP) (time frame: Duration of change in 1 day.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jul 2026.