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.
調査の概要
状態
詳細な説明
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.
研究の種類
入学 (推定)
段階
- 適用できない
連絡先と場所
研究連絡先
- 名前：Taher M Kamal Eldin, B.Sc. in physical therapy
- 電話番号：+201004047580
- メール：taherkamal364@gmail.com
研究場所
-
-
Minya Governorate
-
Minya、Minya Governorate、エジプト
- 募集
- faculty of physical therapy, Deraya University
-
コンタクト：
- Taher M Kamal Eldin, BSc in Physical Therapy
- 電話番号：+201004047580
- メール：taherkamal364@gmail.com
-
-
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：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.
|
|
実験的：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.
|
|
介入なし：control group
participants will receive only routine medical treatment and breathing exercise training
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Forced Expiratory Volume in One Second (FEV1)
時間枠：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)
時間枠：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)
時間枠：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%)
時間枠：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)
時間枠：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
時間枠：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).
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Functional Capacity
時間枠：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)
|
協力者と研究者
スポンサー
捜査官
- スタディチェア：Elsayed E Felaya, Assoiate Professor、Cairo University
- スタディディレクター：Shimaa T Taha, Lecturer、Cairo University
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- CU-TMK-19052026
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。