- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Фаза
- Непригодный
Контакты и местонахождение
Контакты исследования
- Имя: Taher M Kamal Eldin, B.Sc. in physical therapy
- Номер телефона: +201004047580
- Электронная почта: taherkamal364@gmail.com
Места учебы
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-
Minya Governorate
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Minya, Minya Governorate, Египет
- Рекрутинг
- faculty of physical therapy, Deraya University
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Контакт:
- Taher M Kamal Eldin, BSc in Physical Therapy
- Номер телефона: +201004047580
- Электронная почта: taherkamal364@gmail.com
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
Принимает здоровых добровольцев
Описание
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.
Учебный план
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
|
Экспериментальный: 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.
|
|
Экспериментальный: 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.
|
|
Без вмешательства: control group
participants will receive only routine medical treatment and breathing exercise training
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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).
|
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Forced Expiratory Flow at 25-75% of Forced Vital Capacity (FEF25-75%)
Временное ограничение: 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)
Временное ограничение: 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
Временное ограничение: 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).
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Functional Capacity
Временное ограничение: 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)
|
Соавторы и исследователи
Спонсор
Следователи
- Учебный стул: Elsayed E Felaya, Assoiate Professor, Cairo University
- Директор по исследованиям: Shimaa T Taha, Lecturer, Cairo University
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Дополнительные соответствующие термины MeSH
- Заболевания дыхательных путей
- Нарушения дыхания
- Моторная активность
- Движение
- Компания скелетно -скелетно -мышечности
- Скелетно -скелетно -нейронные физиологические явления
- Терапия
- Физиотерапия
- Уход за пациентами
- Физиотерапия
- Реабилитация
- После ухода
- Непрерывность ухода за пациентом
- Физическая кондиционирование, человек
- Упражнение
- Тренировка сопротивления
Другие идентификационные номера исследования
- CU-TMK-19052026
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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