Lung Disease Interstitial Diffuse
Conditions
Keywords
pulmonary rehabilitation, intersticial lung disease, quality of life
Brief 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.
Detailed description
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.
Interventions
OTHERRehabilitation 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.
Sponsors
Hospital Civil de Guadalajara
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
This is a prospective, randomized interventional study with a before-after design. Patients with interstitial lung disease will be randomly assigned (simple randomization) to either the pulmonary rehabilitation program or usual care. The intervention consists of an 8-week pulmonary rehabilitation program with 2-3 supervised sessions per week, including aerobic and strength training, breathing techniques, inspiratory muscle conditioning, and patient education. Allocation: Randomized (simple). Intervention Model: Parallel assignment. Masking: None (open-label). Primary Purpose: Treatment. Primary Outcome: Change in diaphragmatic index Secondary Outcomes: Quality of life , exercise tolerance, muscle strength , and dyspnea. This design will evaluate the effect of pulmonary rehabilitation compared with usual care in improving diaphragmatic function and clinical outcome
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Quality of Life | Baseline and post-intervention (8 weeks) | Short Form Health Survey or Saint George |
| Change in Exercise Tolerance | 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 |
| Change in Dyspnea Perception | Baseline and post-intervention (8 weeks). | Modified Borg Scale (0-10) or mMRC Dyspnea Scale. |
Countries
Mexico
Contacts
Primary ContactEmmanuel Mercado Nuñez Dr- Mercado, Fellowship
Backup ContactJosé Antonio Pantoja, Speciality
Outcome results
None listed