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Clinical Trials in Mexico / NCT07205627
Starting soon Not applicable

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

NCT07205627 · tracked via the Priya Life Science Mexico tracker
Sponsor
Hospital Civil de Guadalajara
Phase
Not applicable
Started
2025-09-25
Last updated
2025-10-03

Condition(s) studied

Lung Disease Interstitial Diffuse

Investigational drug(s) / intervention(s)

Rehabilitation program

Rehabilitation program: Participants will complete an 8-week structured pulmonary rehabilitation program, delivered in 2-3 supervised sessions per week at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde". Each session will last 60-90 minutes and include the following components: Aerobic Training: Walking or cycling at 60-80% of maximum workload, progressively adjusted based on tolerance. Strength Training: Resistance exercises for major muscle groups (upper and lower limbs), 2-3 sets of 10-15 repetitions, individualized according to baseline strength. Breathing Techniques: Diaphragmatic and pursed-lip breathing, plus thoracic expansion exercises. Inspiratory Muscle Conditioning: Threshold device training at 30% of maximal inspiratory pressure (MIP), with progressive increments. Education Sessions: Information on disease self-management, energy conservation, medication adherence, and lifestyle recommendations.

Study summary

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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * 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

Primary outcome measure(s)

  • Change in Diaphragmatic Index — Baseline and post-intervention (8 weeks).
    Variation in diaphragmatic thickness and excursion measured by ultrasound between baseline and after 8 weeks of intervention.

Trial sites (1)

FacilityCityRegionStatus
Department of Physical Rehabilitation at the Civil Hospital of Guadalajara Guadalajara Jalisco

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07205627 on ClinicalTrials.gov ↗ ← All trials in Mexico