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Completed

NCT Number: NCT07765485

Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers

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.

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Key information

Age range

18 year–28 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Physical Therapy, Ahram Canadian University

Giza, October City, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

  • 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.

Treatment and study plan

Pyramidal Aerobic Training

Behavioral

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.

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

    Time frame: Baseline and after 8 weeks of intervention

    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.

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 14, 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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