Department of Physical Rehabilitation at the Civil Hospital of Guadalajara
Guadalajara, Jalisco, 44280, Mexico
NCT Number: NCT07205627
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Guadalajara, Jalisco, 44280, Mexico
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.
Participants will undergo an 8-week pulmonary rehabilitation program consisting of 2-3 supervised sessions per week. The program will include:
Aerobic training tailored to individual tolerance. Muscle strengthening exercises. Breathing techniques and inspiratory muscle conditioning. Patient education and self-management strategies. All variables will be reassessed after completion of the rehabilitation program. The primary outcome is the change in diaphragmatic index. Secondary outcomes include changes in exercise tolerance, quality of life, muscle strength, and dyspnea perception.
This study will be conducted at the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde" between July and December 2025. The findings are expected to provide novel evidence regarding the effects of pulmonary rehabilitation on diaphragmatic function in ILD and may support the development of standardized national guidelines to optimize patient care.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: Baseline and post-intervention (8 weeks).
Variation in diaphragmatic thickness and excursion measured by ultrasound between baseline and after 8 weeks of intervention.
Time frame: Baseline and post-intervention (8 weeks)
Short Form Health Survey or Saint George
Time frame: Baseline and post-intervention (8 weeks)
Improvement in sit to stand test, 6 minutes walking test, Time up and go, and 4 meter gait speed
Time frame: Baseline and post-intervention (8 weeks).
Modified Borg Scale (0-10) or mMRC Dyspnea Scale.
Contact information is provided by the study sponsor or research team.
Emmanuel Mercado Nuñez Dr- Mercado, Fellowship
CONTACT
José Antonio Pantoja, Speciality
CONTACT
Hospital Civil de Guadalajara
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.