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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorHospital Civil de Guadalajara

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • Rehabilitation program

    Other intervention

    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.

Treatment groups

20 Participants
are divided into 1 treatment group
Group A: Rehabilitation programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Change in Diaphragmatic Index

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).

Secondary outcomes

1

Change in Quality of Life

Short Form Health Survey or Saint George

Time frame
Baseline and post-intervention (8 weeks)
2

Change in Exercise Tolerance

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)
3

Change in Dyspnea Perception

Modified Borg Scale (0-10) or mMRC Dyspnea Scale.

Time frame
Baseline and post-intervention (8 weeks).

Other outcomes

Sponsors and contacts

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