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Effect of Aerobic and Resistance Exercise on Quarry Workers (AE RE VF)

3 de agosto de 2026 actualizado por: Taher Mohamed Kamal Eldin, Cairo University

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.

Descripción general del estudio

Estado

Reclutamiento

Condiciones

Intervención / Tratamiento

Descripción detallada

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.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

75

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

  • Nombre: Taher M Kamal Eldin, B.Sc. in physical therapy
  • Número de teléfono: +201004047580
  • Correo electrónico: taherkamal364@gmail.com

Ubicaciones de estudio

  • Egipto
    • Minya Governorate
      • Minya, Minya Governorate, Egipto
        • Reclutamiento
        • faculty of physical therapy, Deraya University
        • Contacto:
          • Taher M Kamal Eldin, BSc in Physical Therapy
          • Número de teléfono: +201004047580
          • Correo electrónico: taherkamal364@gmail.com

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto

Acepta Voluntarios Saludables

No

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: aerobic exercise group
participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training
Procedimiento: Aerobic exercise training
participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training.
Experimental: resistance exercise group
participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.
Procedimiento: Resistance exercise training
participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.
Sin intervención: control group
participants will receive only routine medical treatment and breathing exercise training

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Forced Expiratory Volume in One Second (FEV1)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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%)
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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).

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Capacity
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Cairo University

Investigadores

  • Silla de estudio: Elsayed E Felaya, Assoiate Professor, Cairo University
  • Director de estudio: Shimaa T Taha, Lecturer, Cairo University

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

9 de julio de 2026

Finalización primaria (Estimado)

24 de octubre de 2026

Finalización del estudio (Estimado)

25 de enero de 2027

Fechas de registro del estudio

Enviado por primera vez

30 de julio de 2026

Primero enviado que cumplió con los criterios de control de calidad

30 de julio de 2026

Publicado por primera vez (Actual)

4 de agosto de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

5 de agosto de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

3 de agosto de 2026

Última verificación

1 de julio de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • CU-TMK-19052026

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

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

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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