NCT07003893

Brief Summary

Although research on the health risks of e-cigarettes is still limited, there is increasing evidence of debilitating lung disease and general immune dysfunction from e-cigarettes, leading to various infections. Moreover, there are concerns that e-cigarettes can cause general impairment in life functions and more importantly lung function .Although exercise can help quit smoking and reduce relapses .However, exercise has many other fitness benefits when done regularly for the general population, as well as for smokers. Exercise has been shown to help with smoking cessation, which has been an important factor preventing many smokers, especially younger people, from quitting. Breathing exercises, especially diaphragm exercises improves lung function, lifestyle and health risk factors and thus the risk of developing many chronic diseases. Both aerobic interventions and exercise can reduce the incidence of many of the prevalent cancers initiated by smoking, such as lung cancer. This is important because lung cancer is the most common type of cancer worldwide, and cigarette smoking is responsible for up to 90% of lung cancer cases worldwide.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2025

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 4, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 5, 2025

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 2, 2025

Completed
Last Updated

November 19, 2025

Status Verified

November 1, 2025

Enrollment Period

4 months

First QC Date

May 23, 2025

Last Update Submit

November 15, 2025

Conditions

Outcome Measures

Primary Outcomes (5)

  • FEV1/FVC ( % )

    The ratio of the forced expiratory volume in the first one second to the forced vital capacity of the lungs. That can reflect pulmonary function , using portable spirometer ( SP 80B,China)

    pre and post 4 weeks

  • FEV1 ( liters )

    Forced expiratory volume in 1 second that can reflect pulmonary function , using portable spirometer ( SP 80B,China)

    Pre and post 4 weeks

  • PEF ( liters / minute )

    Peak expiratory flow (PEF), a key indicator of lung function,using portable spirometer ( SP 80B,China)

    pre and post 4 weeks

  • FVC ( liters )

    Forced vital capacity (FVC) is the total amount of air exhaled during the FEV test. Forced expiratory volume and forced vital capacity are lung function tests , using portable spirometer ( SP 80B , China )

    Pre and post 4 weeks

  • Chest expansion ( centimeter )

    A simple, noninvasive pulmonary function test used to assess chest wall mobility and, to a lesser extent, lung function , using tape measurement.

    Pre and post 4 weeks

Secondary Outcomes (1)

  • Functional capacity

    Pre and post 4 weeks

Study Arms (2)

Control group

ACTIVE COMPARATOR

perform exercises using aerobic exercises only

Other: Diaphragmatic Proprioceptive Neuromuscular Facilitation + Aerobic exercises

Experimental group

EXPERIMENTAL

perform diaphragmatic proprioceptive neuromuscular facilitation and aerobic exercise

Other: Diaphragmatic Proprioceptive Neuromuscular Facilitation + Aerobic exercises

Interventions

Control group will perform aerobic exercises only Experimental group will perform diaphragmatic proprioceptive neuromuscular facilitation in addition to aerobic exercises

Control groupExperimental group

Eligibility Criteria

Age20 Years - 29 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Adults aged 20-29 years.
  • Subjects who have been smoking for 1 to 3 years.
  • Subjects who not receiving medical treatment for respiratory diseases.
  • Subjects who have clean family medical history.

You may not qualify if:

  • Subjects who smoke cigars other than filtered cigarettes or tobacco pipes.
  • Subjects with respiratory proplems.
  • Participation in another clinical trial within the last 30 days.
  • Endocrine and metabolic disorders (eg, hypothyroidism, hypercalcemia, diabetes mellitus, diabetes insipidus).
  • Neurologic and psychiatric disorders (who can not understand the research project ).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mohamed Saied Zidan

Cairo, 11571, Egypt

Location

MeSH Terms

Interventions

Exercise

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant prof dr

Study Record Dates

First Submitted

May 23, 2025

First Posted

June 4, 2025

Study Start

July 5, 2025

Primary Completion

November 1, 2025

Study Completion

November 2, 2025

Last Updated

November 19, 2025

Record last verified: 2025-11

Locations