- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07744334
Effect of Aerobic and Resistance Exercise on Quarry Workers (AE RE VF)
Aerobic Versus Resistance Exercise Training on Ventilatory Function in Quarry Workers
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.
Studieoversigt
Status
Intervention / Behandling
Detaljeret beskrivelse
Quarry workers are routinely exposed to respirable dust, which increases the risk of impaired ventilatory function and reduced physical performance. Long-term occupational dust exposure has been associated with respiratory symptoms, decreased pulmonary function, and poorer health-related quality of life. Exercise-based pulmonary rehabilitation is widely recommended to improve respiratory function and physical capacity; however, limited evidence is available regarding the comparative effectiveness of aerobic versus resistance exercise training in quarry workers. This randomized clinical trial aims to compare the effects of aerobic exercise training and resistance exercise training on ventilatory function in quarry workers. Secondary outcomes include functional capacity and health-related quality of life (HRQOL). Seventy-five clinically stable male quarry workers aged 30-40 years will be randomly allocated into three equal groups: an aerobic exercise training group, a resistance exercise training group, and a control group.
Participants in the aerobic and resistance exercise groups will receive their assigned exercise program in addition to routine medical treatment and breathing exercise training. The control group will receive routine medical treatment and breathing exercise training only. All interventions will be performed three times per week for eight consecutive weeks.
Ventilatory function will be assessed using spirometry, including Forced Vital Capacity (FVC), Forced Expiratory Volume in one second (FEV1), FEV1/FVC ratio, Peak Expiratory Flow (PEF), and Maximum Voluntary Ventilation (MVV). Functional capacity will be evaluated using the Harvard Step Test, while health-related quality of life will be assessed using the St. George's Respiratory Questionnaire (SGRQ). Outcome measures will be collected at baseline and after completion of the intervention period.
The findings of this study are expected to identify the most effective exercise modality for improving ventilatory function, functional capacity, and health-related quality of life among quarry workers, thereby providing evidence to optimize pulmonary rehabilitation programs for this occupational population.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: Taher M Kamal Eldin, B.Sc. in physical therapy
- Telefonnummer: +201004047580
- E-mail: taherkamal364@gmail.com
Studiesteder
-
-
Minya Governorate
-
Minya, Minya Governorate, Egypten
- Rekruttering
- faculty of physical therapy, Deraya University
-
Kontakt:
- Taher M Kamal Eldin, BSc in Physical Therapy
- Telefonnummer: +201004047580
- E-mail: taherkamal364@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
Tager imod sunde frivillige
Beskrivelse
Inclusion 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).
Exclusion criteria:
- Patients with acute respiratory infections or recent exacerbation(4-6 weeks).
- Asthmatic patient.
- Chest cancer.
- Musculoskeletal diseases and other disorders that could potentially impact the study's findings are excluded from the trial.
- Other major lung diseases (e.g., TB, ILD, bronchiectasis, cancer).
- Unstable cardiovascular disease.
- Uncontrolled hypertension.
- Severe musculoskeletal or neurological limitation to exercise.
- Cognitive impairment.
- Participation in PR in past 6 months.
- Heavy smokers.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: aerobic exercise group
participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training
|
participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training.
|
|
Eksperimentel: resistance exercise group
participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.
|
participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.
|
|
Ingen indgriben: control group
participants will receive only routine medical treatment and breathing exercise training
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).
|
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)
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).
|
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)
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).
|
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%)
Tidsramme: 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%) 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)
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).
|
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
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).
|
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).
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Functional Capacity
Tidsramme: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)
|
Functional capacity will be assessed using the Harvard Step Test.
The Brouha Index (BI) will be calculated based on exercise duration and recovery heart rate.
Higher scores indicate better functional capacity
|
Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studiestol: Elsayed E Felaya, Assoiate Professor, Cairo University
- Studieleder: Shimaa T Taha, Lecturer, Cairo University
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Luftvejssygdomme
- Respirationsforstyrrelser
- Motorisk aktivitet
- Bevægelse
- Muskuloskeletale fysiologiske fænomener
- Muskuloskeletale og neurale fysiologiske fænomener
- Terapeutik
- Fysioterapimodaliteter
- Patientpleje
- Træningsterapi
- Rehabilitering
- Efterpleje
- Kontinuitet i patientpleje
- Fysisk konditionering, menneske
- Øvelse
- Modstandstræning
Andre undersøgelses-id-numre
- CU-TMK-19052026
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .