Evaluation of the Diaphragmatic Index Before and After a Pulmonary Rehabilitation Program in Patients With Interstitial Lung Diseases and Its Impact on Quality of Life During the Period July-December 2025 at AHCGFAA
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Change in Diaphragmatic Index
研究概览
简要总结
Interstitial lung diseases cause scarring and stiffness of the lungs, leading to impaired breathing and reduced quality of life. The diaphragm, the main respiratory muscle, may become weakened in these patients. Pulmonary rehabilitation is a comprehensive program that includes exercise, education, and support to improve physical capacity and overall well-being.
This study will evaluate whether an eight-week pulmonary rehabilitation program improves the diaphragmatic index (measured by ultrasound), quality of life, exercise tolerance (through functional tests), muscle strength, and dyspnea perception in patients with interstitial lung diseases.
Participants will be recruited at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" between July and December 2025. The findings will provide new insights into the impact of pulmonary rehabilitation on diaphragmatic function and contribute scientific evidence to optimize the treatment of these conditions.
详细描述
This is a prospective longitudinal before-after study designed to evaluate the impact of a structured pulmonary rehabilitation program on diaphragmatic function and patient-reported outcomes in individuals with interstitial lung diseases (ILD).
A minimum of 20 patients with a confirmed diagnosis of ILD by pulmonology and imaging criteria will be enrolled. Baseline assessments will include:
Diaphragmatic index measured by ultrasound (thickness and excursion during inspiration and expiration).
Quality of life using the SF-12, or 36 or Saint George questionnaire. Exercise tolerance assessed by functional tests (4-meter gait speed, sit-to-stand, and timed up-and-go, 6 minutes walking test).
Muscle strength measured with hand dynamometry. Dyspnea evaluated using the Borg scale or mMRC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years.
- •Confirmed diagnosis of interstitial lung disease (ILD) by pulmonology and imaging criteria.
- •Clinically stable for at least 4 weeks prior to enrollment (no exacerbations or hospitalizations).
- •Able to perform pulmonary rehabilitation and functional tests safely, as determined by medical evaluation.
- •Willing and able to provide written informed consent.
排除标准
- •Acute exacerbation of ILD or respiratory infection within the last 4 weeks.
- •Severe comorbidities limiting participation (e.g., unstable cardiac disease, uncontrolled hypertension, recent myocardial infarction < 3 months).
- •Advanced neuromuscular disease or musculoskeletal limitation that prevents exercise training.
- •Cognitive impairment or psychiatric condition interfering with protocol adherence.
- •Pregnancy or breastfeeding
结局指标
主要结局
Change in Diaphragmatic Index
时间窗: Baseline and post-intervention (8 weeks).
Variation in diaphragmatic thickness and excursion measured by ultrasound between baseline and after 8 weeks of intervention.
次要结局
- Change in Quality of Life(Baseline and post-intervention (8 weeks))
- Change in Exercise Tolerance(Baseline and post-intervention (8 weeks))
- Change in Dyspnea Perception(Baseline and post-intervention (8 weeks).)
研究者
Emmanuel Mercado Nuñez
Dr. Emmanuel Mercado Nuñez
Hospital Civil de Guadalajara