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

3 de agosto de 2026 atualizado 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.

Visão geral do estudo

Status

Recrutamento

Condições

Intervenção / Tratamento

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

75

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

  • Nome: Taher M Kamal Eldin, B.Sc. in physical therapy
  • Número de telefone: +201004047580
  • E-mail: taherkamal364@gmail.com

Locais de estudo

  • Egito
    • Minya Governorate
      • Minya, Minya Governorate, Egito
        • Recrutamento
        • faculty of physical therapy, Deraya University
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: aerobic exercise group
participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training
Procedimento: 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.
Procedimento: Resistance exercise training
participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.
Sem intervenção: control group
participants will receive only routine medical treatment and breathing exercise training

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Forced Expiratory Volume in One Second (FEV1)
Prazo: 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)
Prazo: 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)
Prazo: 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%)
Prazo: 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)
Prazo: 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
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Functional Capacity
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Cairo University

Investigadores

  • Cadeira de estudo: Elsayed E Felaya, Assoiate Professor, Cairo University
  • Diretor de estudo: Shimaa T Taha, Lecturer, Cairo University

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

9 de julho de 2026

Conclusão Primária (Estimado)

24 de outubro de 2026

Conclusão do estudo (Estimado)

25 de janeiro de 2027

Datas de inscrição no estudo

Enviado pela primeira vez

30 de julho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

30 de julho de 2026

Primeira postagem (Real)

4 de agosto de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

5 de agosto de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de agosto de 2026

Última verificação

1 de julho de 2026

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CU-TMK-19052026

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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