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

September 25, 2025 updated by: Emmanuel Mercado Nuñez, Hospital Civil de Guadalajara

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Mexico
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Department of Physical Rehabilitation at the Civil Hospital of Guadalajara
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rehabilitation program
Type of Intervention: Behavioral (Rehabilitation Program) Description: Participants will undergo an 8-week pulmonary rehabilitation program, 2-3 supervised sessions per week. The program includes aerobic training, muscle strengthening, breathing techniques, inspiratory muscle conditioning, and patient education. All sessions will be tailored to individual tolerance and supervised by rehabilitation specialists.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline and post-intervention (8 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Quality of Life
Time Frame: Baseline and post-intervention (8 weeks)
Short Form Health Survey or Saint George
Baseline and post-intervention (8 weeks)
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
Baseline and post-intervention (8 weeks)
Change in Dyspnea Perception
Time Frame: Baseline and post-intervention (8 weeks).
Modified Borg Scale (0-10) or mMRC Dyspnea Scale.
Baseline and post-intervention (8 weeks).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Civil de Guadalajara

Investigators

  • Study Director: Armando Tonatiuh Avila Garcia, Master Degree, Hospital Civil de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 25, 2025

Primary Completion (Estimated)

December 1, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

September 25, 2025

First Submitted That Met QC Criteria

September 25, 2025

First Posted (Estimated)

October 3, 2025

Study Record Updates

Last Update Posted (Estimated)

October 3, 2025

Last Update Submitted That Met QC Criteria

September 25, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEI 1167/25

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The study involves a small sample size, and data are considered sensitive. Only aggregated results will be shared in publications and reports.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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