NCT07744334

Brief Summary

The goal of this randomized clinical trial is to compare the effects of aerobic exercise training and resistance exercise training on ventilatory function in quarry workers. It will also evaluate their effects on functional capacity and health-related quality of life (HRQOL). The main questions it aims to answer are: Does aerobic exercise training improve ventilatory function more effectively than resistance exercise training? How do aerobic and resistance exercise training affect functional capacity and health-related quality of life in quarry workers? Researchers will compare aerobic exercise training and resistance exercise training with a control group receiving routine treatment and breathing exercises to determine which intervention is more effective in improving ventilatory function, functional capacity, and health-related quality of life. Participants will: Be randomly assigned to one of three groups: an aerobic exercise training group, a resistance exercise training group, or a control group. Receive the assigned intervention three times per week for eight consecutive weeks. Undergo ventilatory function assessment using spirometry. Complete assessments of functional capacity and health-related quality of life before and after the intervention.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
6mo left

Started Jul 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress14%
Jul 2026Jan 2027

Study Start

First participant enrolled

July 9, 2026

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

July 30, 2026

Completed
5 days until next milestone

First Posted

Study publicly available on registry

August 4, 2026

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 24, 2026

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 25, 2027

Last Updated

August 4, 2026

Status Verified

July 1, 2026

Enrollment Period

4 months

First QC Date

July 30, 2026

Last Update Submit

July 30, 2026

Conditions

Outcome Measures

Primary Outcomes (6)

  • Forced Expiratory Volume in One Second (FEV1)

    Forced Expiratory Volume in One Second (FEV1) will be assessed using spirometry. FEV1 is the volume of air forcefully exhaled during the first second of a forced expiratory maneuver and is expressed in liters (L). Higher values indicate better airway function and ventilatory performance.

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).

  • Forced Vital Capacity (FVC)

    Forced Vital Capacity (FVC) will be assessed using spirometry. FVC is the maximum volume of air that can be forcefully exhaled after a full inspiration and is expressed in liters (L). Higher values indicate better ventilatory function.

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).

  • Forced Expiratory Volume in One Second to Forced Vital Capacity Ratio (FEV1/FVC)

    The FEV1/FVC ratio will be assessed using spirometry and expressed as a percentage (%). This parameter reflects the proportion of the forced vital capacity exhaled during the first second of expiration and is commonly used to evaluate airflow limitation. Higher values generally indicate better ventilatory function.

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).

  • Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%)

    Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%) will be assessed using spirometry. FEF25-75% represents the average expiratory flow during the middle half of the forced vital capacity maneuver and is expressed in liters per second (L/s). It is considered a sensitive indicator of small airway function. Higher values indicate better small airway function and ventilatory performance.

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)

  • Maximum Voluntary Ventilation (MVV)

    Maximum Voluntary Ventilation (MVV) will be assessed using spirometry. MVV is the maximum volume of air inhaled and exhaled voluntarily within one minute and is expressed in liters per minute (L/min). Higher values indicate better respiratory muscle endurance and ventilatory capacity.

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).

  • Health-Related Quality of Life

    Health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). The SGRQ consists of 50 items grouped into three domains: Symptoms, Activity, and Impacts. Total scores range from 0 to 100, with higher scores indicating poorer health-related quality of life. Lower scores represent better outcomes

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).

Secondary Outcomes (1)

  • Functional Capacity

    Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)

Study Arms (3)

aerobic exercise group

EXPERIMENTAL

participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training

Procedure: Aerobic exercise training

resistance exercise group

EXPERIMENTAL

participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.

Procedure: Resistance exercise training

control group

NO INTERVENTION

participants will receive only routine medical treatment and breathing exercise training

Interventions

participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training.

aerobic exercise group

participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.

resistance exercise group

Eligibility Criteria

Age30 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients will be included in the study if they have the following criteria:
  • Male quarry workers.
  • The age range is between 30 and 40 years.
  • BMI values from 25 to 29.9 kg/m².
  • They work 5 to 6 times per weeks with mean exposure range (5-10 years) (Kumar et al., 2014). Exhibited chest manifestations (Respiratory symptoms) like cough, dyspnea, wheeze, and ventilatory impairment with significant reduction in (FEV1/FVC\<70% and/or FVC\<80% and reduce Peak Expiratory flow 25- 75% (PEF25-75%)(Abdelwahaab et al., 2025).
  • Clinically stable (no exacerbation in past 4-6 weeks).
  • Low levels of physical activity (using the International Physical Activity Questionnaire-Short Version) (The Arabic version of the questionnaire will be used).

You may not qualify if:

  • The patients will be excluded from this study if they have one of the
  • Following criteria:
  • a) Patients with acute respiratory infections or recent exacerbation(4-6 weeks). b) Asthmatic patient. c) Chest cancer. d) Musculoskeletal diseases and other disorders that could potentially impact the study's findings are excluded from the trial. e) Other major lung diseases (e.g., TB, ILD, bronchiectasis, cancer). f) Unstable cardiovascular disease. g) Uncontrolled hypertension. h) Severe musculoskeletal or neurological limitation to exercise. i) Cognitive impairment. j) Participation in PR in past 6 months. k) Heavy smokers.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Physical Therapy, Deraya University

Minya, Minya Governorate, Egypt

RECRUITING

MeSH Terms

Conditions

Respiration Disorders

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Elsayed E Felaya, Assoiate Professor

    Cairo University

    STUDY CHAIR
  • Shimaa T Taha, Lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Taher M Kamal Eldin, B.Sc. in physical therapy

CONTACT

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

Study Record Dates

First Submitted

July 30, 2026

First Posted

August 4, 2026

Study Start

July 9, 2026

Primary Completion (Estimated)

October 24, 2026

Study Completion (Estimated)

January 25, 2027

Last Updated

August 4, 2026

Record last verified: 2026-07

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared to maintain participant privacy and strictly adhere to confidentiality agreements.

Locations