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CompletedNCT07765485Updated Aug 14, 2026

Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers

An interventional study of Pyramidal Aerobic Training in Cigarette Smoking, Impaired Ventilatory Function and Respiratory Function in Adult Smokers, sponsored by Cairo University. Completed at 1 site in Egypt. Open to male participants aged 18 Years to 28 Years. Per ClinicalTrials.gov, last updated 2026-08-14.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
18 Years to 28 Years
Sex
Male
01

Study 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 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.

02

Conditions studied

  • Cigarette Smoking
  • Impaired Ventilatory Function
  • Respiratory Function in Adult Smokers

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03

Who can participate

Ages eligible
18 Years to 28 Years
Sexes eligible
Male
Accepts healthy volunteers
No

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • 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.
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Pyramidal Aerobic Training Group

    Participants will receive pyramidal aerobic training on a treadmill three times per week for eight consecutive weeks.

    Behavioral: Pyramidal Aerobic Training

  • No intervention
    Control Group

    Participants will be assigned to the control group.

Interventions

  • BehavioralPyramidal Aerobic Training

    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.

05

What researchers measure

Primary outcomes

  1. Forced Expiratory Volume in 1 Second (FEV1)

    Time frame: Baseline and after 8 weeks of intervention

  2. Forced Vital Capacity (FVC)

    Time frame: Baseline and after 8 weeks of intervention

  3. FEV1/FVC Ratio

    Time frame: Baseline and after 8 weeks of intervention

  4. Peak Expiratory Flow Rate (PEFR)

    Time frame: Baseline and after 8 weeks of intervention

Secondary outcomes

  1. Functional Capacity (VO2max)

    Time frame: Baseline and after 8 weeks of intervention

  2. Health-Related Quality of Life (SF-12)

    Time frame: Baseline and after 8 weeks of intervention

  3. 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.

    Time frame: Baseline and after 8 weeks of intervention

06

Study locations

1 site
  • Faculty of Physical Therapy, Ahram Canadian University
    Giza, October City, Egypt
07

Registry details

Key details

Study ID
NCT07765485
Lead sponsor
Cairo University
Responsible party
Tarek Taha Fathy (Teaching Assistant, Cairo University) — Principal investigator
First posted
Aug 14, 2026
Start date
Sep 6, 2025
Primary completion
Feb 10, 2026
Completion
Apr 15, 2026
Last update
Aug 14, 2026

Study contacts

Tarek Taha Fathy
principal investigator · Cairo University

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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