Effect of Pyramidal Aerobic Training on Ventilatory Function in Cigarette Smokers

NCT07765485 | Completed

• 1 other identifier: P.T.REC/012/006336
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Forced Expiratory Volume in 1 Second (FEV1)

  Baseline and after 8 weeks of intervention

• Forced Vital Capacity (FVC)

  Baseline and after 8 weeks of intervention

• FEV1/FVC Ratio

  Baseline and after 8 weeks of intervention

• Peak Expiratory Flow Rate (PEFR)

  Baseline and after 8 weeks of intervention

Secondary Outcomes (3)

• Functional Capacity (VO2max)

  Baseline and after 8 weeks of intervention

• Health-Related Quality of Life (SF-12)

  Baseline and after 8 weeks of intervention

• Smoking Abstinence Self-Efficacy Questionnaire (SASEQ) Score

  Baseline and after 8 weeks of intervention

Study Arms (2)

Pyramidal Aerobic Training Group

EXPERIMENTAL

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

Behavioral: Pyramidal Aerobic Training

Control Group

NO INTERVENTION

Participants will be assigned to the control group.

Interventions

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.

Pyramidal Aerobic Training Group

Eligibility Criteria

• Age: 18 Years - 28 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Faculty of Physical Therapy, Ahram Canadian University

Giza, October City, Egypt

Location

MeSH Terms

Conditions

Cigarette Smoking

Condition Hierarchy (Ancestors)

Tobacco Smoking; Smoking; Behavior; Tobacco Use

Study Officials

• Tarek Taha Fathy

  Cairo University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Model Details: Participants will be randomly assigned into two parallel groups: a pyramidal aerobic training group and a control group.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: September 6, 2025
• Primary Completion: February 10, 2026
• Study Completion: April 15, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

EG (1)