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

NCT07205627 | Not Yet Recruiting

• 1 other identifier: CEI 1167/25
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Disease Interstitial Diffuse

Keywords

pulmonary rehabilitation; intersticial lung disease; quality of life

Outcome Measures

Primary Outcomes (1)

• Change in Diaphragmatic Index

  Variation in diaphragmatic thickness and excursion measured by ultrasound between baseline and after 8 weeks of intervention.

  Baseline and post-intervention (8 weeks).

Secondary Outcomes (3)

• Change in Quality of Life

  Baseline and post-intervention (8 weeks)

• Change in Exercise Tolerance

  Baseline and post-intervention (8 weeks)

• Change in Dyspnea Perception

  Baseline and post-intervention (8 weeks).

Study Arms (1)

Rehabilitation program

EXPERIMENTAL

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

Interventions

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.

Rehabilitation program

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospital Civil de Guadalajara: lead

Study Sites (1)

Department of Physical Rehabilitation at the Civil Hospital of Guadalajara

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (14)

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  BACKGROUND

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MeSH Terms

Interventions

Rehabilitation

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Armando Tonatiuh Avila Garcia, Master Degree

  Hospital Civil de Guadalajara

  STUDY DIRECTOR

Central Study Contacts

Emmanuel Mercado Nuñez Dr- Mercado, Fellowship

CONTACT

+52 3330584121; emercadonunez@hcg.gob.mx

José Antonio Pantoja, Speciality

CONTACT

+52 3339459211; dr.jpantoja@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Emmanuel Mercado Nuñez

Model Details: 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

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: October 3, 2025
• Study Start: September 25, 2025
• Primary Completion: December 1, 2025
• Study Completion: December 30, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)