Cigarette SmokingNCT07765485
Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers
A study testing Pyramidal Aerobic Training in people with Cigarette Smoking and Impaired Ventilatory Function, run by Cairo University at 1 site in Egypt.
Trial summary
Statement of the problem: Does the pyramidal aerobic training affect ventilatory function parameters in smokers? Null hypothesis: Pyramidal aerobic training has no significant effect on ventilatory function parameters (such as Forced Vital Capacity [FVC], Forced Expiratory Volume in one second [FEV₁], and Peak… Read more about this study
- Who is it for?
- Ages 18 to 28 years, men only
- Conditions the study is for
- Cigarette Smoking, Impaired Ventilatory Function, Respiratory Function in Adult Smokers
- What is being tested?
- Pyramidal Aerobic Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 6 Sep 2025to 15 Apr 2026
- 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 28 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- Cigarette smoker males aged from 18 to 28 years.
- Smoking index = 50.
- Sedentary lifestyle.
- BMI between 18.5 and 29.9 kg/m².
- Cigarette smokers demonstrate mild to moderate impairment in ventilatory function confirmed by baseline spirometry.
- SASEQ (Smoking Abstinence Self-Efficacy Questionnaire) moderate self-efficacy, score from 9 to 16.
- Cigarette smokers are able and willing to participate in aerobic training sessions
Who cannot join
- Patients diagnosed with chronic respiratory diseases such as asthma.
- Patients with cardiovascular diseases or other systemic illnesses that contraindicate exercise.
- Patients who experienced recent respiratory infections within the last 4 weeks.
- Patients currently engaged in regular structured aerobic or respiratory training programs.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Physical Therapy, Ahram Canadian University
Giza, October City
About this study
Statement of the problem:
Does the pyramidal aerobic training affect ventilatory function parameters in smokers?
Null hypothesis:
Pyramidal aerobic training has no significant effect on ventilatory function parameters (such as Forced Vital Capacity [FVC], Forced Expiratory Volume in one second [FEV₁], and Peak Expiratory Flow Rate [PEFR]) in adult smokers.
Read the detailed description
This randomized controlled trial evaluates the effect of an eight-week pyramidal aerobic training program on ventilatory function in cigarette smokers. Forty male cigarette smokers aged 18 to 28 years will be randomly allocated to either a pyramidal aerobic training group or a control group. The intervention group will perform treadmill-based pyramidal aerobic training three times per week for eight consecutive weeks. Each session will include a warm-up, pyramidal aerobic training with ascending and descending intensity levels, and a cool-down. Training intensity will range from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula. Ventilatory function will be assessed by spirometry, while functional capacity, health-related quality of life, and smoking abstinence self-efficacy will also be assessed at baseline and after the intervention.
- Being tested
- Pyramidal Aerobic Training
- Medical subject headings
- Cigarette Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pyramidal Aerobic TrainingBehavioural
Pyramidal aerobic training performed on a motorized treadmill three times per week for eight consecutive weeks. Each session consists of 5 minutes of warm-up, 20 minutes of pyramidal aerobic training with 5 ascending and 5 descending intensity levels, each lasting 2 minutes, followed by 5 minutes of cool-down. Training intensity ranges from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula, with heart rate monitored using a pulse oximeter.
| Study group | Role | What they receive |
|---|---|---|
| Pyramidal Aerobic Training Group | Experimental | Participants will receive pyramidal aerobic training on a treadmill three times per week for eight consecutive weeks. Receives: Behavioral: Pyramidal Aerobic Training |
| Control Group | No intervention | Participants will be assigned to the control group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced Expiratory Volume in 1 Second (FEV1)
Measured: Baseline and after 8 weeks of intervention
Forced Vital Capacity (FVC)
Measured: Baseline and after 8 weeks of intervention
FEV1/FVC Ratio
Measured: Baseline and after 8 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Measured: Baseline and after 8 weeks of intervention
Secondary outcomes (3)
Functional Capacity (VO2max)
Measured: Baseline and after 8 weeks of intervention
Health-Related Quality of Life (SF-12)
Measured: Baseline and after 8 weeks of intervention
Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) Score
Smoking abstinence self-efficacy will be assessed using the Smoking Abstinence Self-Efficacy Questionnaire (SASEQ). The questionnaire score ranges from 9 to 16, with higher scores indicating greater smoking abstinence self-efficacy.
Measured: Baseline and after 8 weeks of intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2026
- Study start6 Sep 2025
- Primary completion10 Feb 2026
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokingStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Model description
- Participants will be randomly assigned into two parallel groups: a pyramidal aerobic training group and a control group.
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tarek Taha Fathy, Cairo University
- Investigators
- Tarek Taha Fathy, Principal investigator, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07765485
- Sponsor's protocol ID
- P.T.REC/012/006336
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 14 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers
- ClinicalTrials.gov ID
- NCT07765485
- Acronym / sponsor ID
- P.T.REC/012/006336
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 6 Sep 2025 (actual)
- Primary completion
- 10 Feb 2026 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 14 Aug 2026 (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.
Statement of the problem:
Does the pyramidal aerobic training affect ventilatory function parameters in smokers?
Null hypothesis:
Pyramidal aerobic training has no significant effect on ventilatory function parameters (such as Forced Vital Capacity [FVC], Forced Expiratory Volume in one second [FEV₁], and Peak Expiratory Flow Rate [PEFR]) in adult smokers.
Detailed description
This randomized controlled trial evaluates the effect of an eight-week pyramidal aerobic training program on ventilatory function in cigarette smokers. Forty male cigarette smokers aged 18 to 28 years will be randomly allocated to either a pyramidal aerobic training group or a control group. The intervention group will perform treadmill-based pyramidal aerobic training three times per week for eight consecutive weeks. Each session will include a warm-up, pyramidal aerobic training with ascending and descending intensity levels, and a cool-down. Training intensity will range from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula. Ventilatory function will be assessed by spirometry, while functional capacity, health-related quality of life, and smoking abstinence self-efficacy will also be assessed at baseline and after the intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned into two parallel groups: a pyramidal aerobic training group and a control group.
| Arm | Type | Receives |
|---|---|---|
| Pyramidal Aerobic Training Group | Experimental | Behavioral: Pyramidal Aerobic TrainingParticipants will receive pyramidal aerobic training on a treadmill three times per week for eight consecutive weeks. |
| Control Group | No intervention | –Participants will be assigned to the control group. |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Cigarette smoker males aged from 18 to 28 years.
- Smoking index = 50.
- Sedentary lifestyle.
- BMI between 18.5 and 29.9 kg/m².
- Cigarette smokers demonstrate mild to moderate impairment in ventilatory function confirmed by baseline spirometry.
Key exclusion criteria (4 listed)
- Patients diagnosed with chronic respiratory diseases such as asthma.
- Patients with cardiovascular diseases or other systemic illnesses that contraindicate exercise.
- Patients who experienced recent respiratory infections within the last 4 weeks.
- Patients currently engaged in regular structured aerobic or respiratory training programs.
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 |
|---|---|---|
| Pyramidal Aerobic TrainingPyramidal aerobic training performed on a motorized treadmill three times per week for eight consecutive weeks. Each session consists of 5 minutes of warm-up, 20 minutes of pyramidal aerobic training with 5 ascending and 5 descending intensity levels, each lasting 2 minutes, followed by 5 minutes of cool-down. Training intensity ranges from 20% to 80% of the participant's target heart rate calculated using the Karvonen formula, with heart rate monitored using a pulse oximeter. | Behavioural | Pyramidal Aerobic Training Group |
Primary outcome
Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Baseline and after 8 weeks of intervention
Forced Vital Capacity (FVC)
Time frame: Baseline and after 8 weeks of intervention
FEV1/FVC Ratio
Time frame: Baseline and after 8 weeks of intervention
Peak Expiratory Flow Rate (PEFR)
Time frame: Baseline and after 8 weeks of intervention
3 secondary outcomes
Functional Capacity (VO2max)
Time frame: Baseline and after 8 weeks of intervention
Health-Related Quality of Life (SF-12)
Time frame: Baseline and after 8 weeks of intervention
Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) Score
Time frame: Baseline and after 8 weeks of intervention
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 14 Aug 2026.
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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.
Tarek Taha Fathy principal investigator
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pyramidal Aerobic Training in people with Cigarette Smoking and Impaired Ventilatory Function, run by Cairo University at 1 site in Egypt.
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 7 inclusion and 4 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 14 Aug 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 Egypt. 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?
Forced Expiratory Volume in 1 Second (FEV1) (time frame: Baseline and after 8 weeks of intervention). The study lists 4 primary outcomes in all. 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 14 Aug 2026.