Effects of Combined Inspiratory Muscle Training and Positive Expiratory Pressure Therapy on Pulmonary Function, Respiratory Muscle Strength, Exercise Capacity and Dyspnea in Stable Group E COPD Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy
研究概览
简要总结
Background:
Inspiratory muscle training combined with positive expiratory pressure (IMT/PEP) may improve outcomes in chronic obstructive pulmonary disease (COPD), but evidence in exacerbation-prone (Group E) disease is limited. This study is designed to evaluate the effects of IMT/PEP on pulmonary function, respiratory muscle strength, exercise capacity, and dyspnea in stable Group E COPD.
Methods :
This prospective randomized controlled trial will enroll 62 patients with stable Group E COPD between June 2023 and September 2024. Participants will be randomized to receive IMT/PEP plus standard care or standard care alone. Pulmonary function tests, maximal inspiratory pressure (MIP), maximal expiratory pressure (MEP), six-minute walk test (6MWT), oxygen saturation (SO₂), and dyspnea scales (mMRC, CAT, MBS, VAS) will be assessed at baseline, 1 month, and 3 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 40 years
- •Diagnosis of Group E COPD according to GOLD 2023 criteria
- •Post-bronchodilator FEV₁/FVC < 0.70 and FEV₁ < 50% predicted
- •mMRC score ≥ 2 or CAT score ≥ 10
- •History of ≥2 exacerbations or ≥1 hospitalization in the past year
- •Stable clinical condition (no exacerbation in the past 2 weeks)
- •Ability and willingness to perform IMT/PEP therapy
- •Provided written informed consent
排除标准
- •Acute exacerbation of COPD at time of enrollment
- •Contraindications to pulmonary function testing or 6-minute walk test (e.g., recent myocardial infarction, unstable angina)
- •Inability to perform inspiratory or expiratory maneuvers reliably (e.g., due to cognitive or neuromuscular disorders)
- •Significant orofacial muscle weakness unresponsive to modified mouthpiece
- •Participation in another interventional study within the past 3 months
- •Nonadherence to COPD treatment plan
- •Any condition deemed by investigators to interfere with study participation
结局指标
主要结局
Change in Maximal Inspiratory Pressure (MIP) After 12 Weeks of IMT/PEP Therapy
时间窗: Baseline and Week 12
Maximal inspiratory pressure (MIP) was measured at baseline and after 12 weeks using a digital manometer at residual volume (RV) to evaluate the effect of IMT/PEP therapy on inspiratory muscle strength.
Change in Residual Volume (RV) After 12 Weeks of IMT/PEP Therapy
时间窗: Baseline and Week 12
Residual volume (RV) was obtained through whole-body plethysmography at baseline and after 12 weeks to assess the impact of IMT/PEP therapy on pulmonary hyperinflation.
次要结局
未报告次要终点
研究者
Bugra Kerget
Asc.Prof.Dr.
Ataturk University