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NCT Number: NCT07205627

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Rehabilitation at the Civil Hospital of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location contact

Emmanuel Mercado, Fellowship

CONTACT

[email protected]

3339424400 ext. 43038

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rehabilitation program

Other

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.

Primary outcomes

  1. Change in Diaphragmatic Index

    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.

Secondary outcomes

  1. Change in Quality of Life

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

    Short Form Health Survey or Saint George

  2. Change in Exercise Tolerance

    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

  3. Change in Dyspnea Perception

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Emmanuel Mercado Nuñez Dr- Mercado, Fellowship

CONTACT

[email protected]

+52 3330584121

José Antonio Pantoja, Speciality

CONTACT

[email protected]

+52 3339459211

Sponsors and collaborators

Lead sponsor

Hospital Civil de Guadalajara

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Oct 3, 2025
Registry last updated
Oct 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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.