Physical Exercise Program for Adults With Diffuse Interstitial Lung Disease in a Pulmonary Rehabilitation Context

NCT07061873 | Enrolling By Invitation DMC

• 2 other identifiers: ECA RP-EPIDDI24-011
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the effectiveness of an exercise program that includes three exercise modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program that includes only one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of exercise tolerance. A randomized clinical trial will be conducted, with 2 parallel groups, with masked evaluator. This study will include adults with a diagnosis of Diffuse Interstitial Lung Disease who are referred according to their medical condition and who agree to participate through an informed consent form. Participants will be recruited in the community and will be referred to the Physical Function and Rehabilitation Laboratory of the Faculty of Medicine of the Universidad de La Frontera, where they will be evaluated and subsequently randomly assigned to each group. The evaluation consists of a series of tests and instruments to collect information regarding dyspnea, exercise tolerance, muscle strength and lung function, among others. The intervention corresponds to a Pulmonary Rehabilitation program, where both groups will receive education in psychological and nutritional aspects, self-care and physical activity. The difference between groups is that the control group will receive an intervention with an aerobic exercise modality and the experimental group will receive three exercise modalities together (aerobic, strengthening of extremities and strengthening of respiratory muscles).The program will last 10 weeks, with sessions twice a week, and at the end of the program the initial parameters will be re-evaluated. Data analysis will be performed using descriptive statistical elements, such as distribution tables and graphs. The inferential analysis will be performed using Chi2 for the association between the intervention and the main outcome variable, in addition to the calculation of RR to assess the magnitude of the association; the secondary outcome variables will be calculated for the primary outcome variable association; secondary outcome variables will be analyzed using Student's t-test.

Conditions

Interstitial Lung Disease Due to Systemic Disease (Disorder); Interstitial Lung Disease in Patients With Rheumatoid Arthritis; Pulmonary Fibrosis

Keywords

ILD; Pulmonary rehabilitation; aerobic excercise; limb strenght; respiratory muscle strenght

Outcome Measures

Primary Outcomes (1)

• Exercise tolerance

  It is the body's ability to withstand physical activity. It is measured by the duration and intensity of exercise that a person can perform without excessive fatigue, pain or shortness of breath.

  Baseline and then at the end of the 10-week training period

Secondary Outcomes (10)

• Perceived effort

  Baseline and then at the end of the 10-week training period

• Dyspnea

  Baseline and then at the end of the 10-week training period

• Inspiratory muscle strength

  Baseline and then at the end of the 10-week training period

• Muscle strenght of limbs

  Baseline and then at the end of the 10-week training period.

• Muscle strenght of arms

  Baseline and then at the end of the 10-week training period

Other Outcomes (4)

• Age

  Baseline

• Gender

  Baseline

• Previous hospitalizations

  Baseline

Study Arms (2)

Control

OTHER

Control (Aerobic excercise)

Procedure: Aerobic excersise

Intervention

EXPERIMENTAL

Intervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise)

Procedure: Aerobic excersise; Procedure: Muscle strength limbs, inspiratory muscle strength

Interventions

Aerobic excersise PROCEDURE

20 aerobic exercise sessions, with a duration of 45 to 60 minutes, for 10 weeks.

Control; Intervention

Muscle strength limbs, inspiratory muscle strength PROCEDURE

20 sessions of exercise Muscle strength limbs, inspiratory muscle strength, with a duration of 60 minutes, for 10 weeks

Intervention

Eligibility Criteria

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

You may qualify if:

• Adults 18 years of age or older.
• Medical Diagnosis of Diffuse Interstitial Pulmonary Disease.
• Medical Referral to pulmonary rehabilitation according to stability criteria.
• Sign the Informed Consent form.

You may not qualify if:

• Neuromotor impairment that prevents independent transfer.
• Cognitive deficit that prevents you from understanding simple instructions.
• General exercise contraindications according to the American College of Sports Medicine.

Sponsors & Collaborators

• Universidad de La Frontera: lead

Study Sites (1)

Universidad de La Frontera

Temuco, Cautín, 4780000, Chile

Location

Related Links

• Web page of School of Medicine Universida de La Frontera

MeSH Terms

Conditions

Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physical Therapist; Specialist in Ventilatory Terapy; Master in Innovation of Universitary Pedagogy in Education Science; Academic Department Science of Rehabilitation, University of La Frontera

Study Record Dates

• First Submitted: March 21, 2025
• First Posted: July 11, 2025
• Study Start: October 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Five years since publication in Clinical Trials.
• Access Criteria: All people, just contact for e-mail.

Locations

CL (1)