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Идёт набор NCT07744334

Effect of Aerobic and Resistance Exercise on Quarry Workers

Без фазы С лечением Ventilatory Defect Occupational Lung Diseases Respiratory Disorders

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Aerobic exercise training, Resistance exercise training.
Кому может быть актуально
Состояния в реестре: Ventilatory Defect, Occupational Lung Diseases, Respiratory Disorders. Базовые параметры: 30 лет — 40 лет · Мужчины.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Египет
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Aerobic Versus Resistance Exercise Training on Ventilatory Function in Quarry Workers

Обзор

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.

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.

Вмешательства

  • Процедура Aerobic exercise training
    participants will receive aerobic exercise training in addition to routine medical treatment and breathing exercise training.
  • Процедура Resistance exercise training
    participants will receive resistance exercise training in addition to routine medical treatment and breathing exercise training.

Первичные конечные точки

  • Forced Expiratory Volume in One Second (FEV1) [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).]
  • Forced Vital Capacity (FVC) [Срок оценки: 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) [Срок оценки: 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%) [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)]
  • Maximum Voluntary Ventilation (MVV) [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).]
  • Health-Related Quality of Life [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention).]
Вторичные конечные точки (1)
  • Functional Capacity [Срок оценки: Baseline (pre-intervention) and at the end of the 8-week intervention period (post-intervention)]

Критерии участия

Критерии включения

  • 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).

Критерии исключения

  • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение
Рандомизированное
Модель
Параллельные группы
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Египет · 1 центр
  • Faculty of Physical Therapy, Deraya University — Minya

Идентификаторы

NCT: NCT07744334 · CU-TMK-19052026

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗