Trials / Enrolling By Invitation

Enrolling By InvitationNCT07061873

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

Status: Enrolling By Invitation
Phase: N/A
Study type: Interventional
Enrollment: 29 (estimated)

Sponsor: Universidad de La Frontera · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

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.

Detailed description

General Objective: 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 carriers of diffuse interstitial disease in the Araucanía Region, in terms of exercise tolerance. Specific Objectives: 1. To evaluate the effectiveness of an exercise program that includes three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program of only one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults carriers of diffuse interstitial disease in the Araucanía Region, in terms of exercise tolerance. 2. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus a one-modality exercise program (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of dyspnea control. 3. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in Health-Related Quality of Life. 4. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease of the Araucanía Region, in terms of upper limb strength. 5. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of lower limb strength. 6. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in terms of inspiratory muscle strength. 7. To evaluate the effectiveness of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus an exercise program with one modality (Aerobic) within a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region, in pulmonary function. 8. To evaluate the adherence to treatment of an exercise program with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) and the exercise program of one modality (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region. 9. To evaluate the incidence of adverse effects that lead to stopping the exercise session according to the exercise program: with three modalities (Aerobic, Limb Strength and Respiratory Muscle Strength) versus a one-modality exercise program (Aerobic) in the context of a Pulmonary Rehabilitation program in adults with diffuse interstitial disease in the Araucanía Region. 10. To describe the functionality in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region. 11. To describe the cognitive function in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region. Design It corresponds to a randomized clinical trial, 2 parallel groups, with masked evaluator. This design is the one that provides the best certainty of evidence to attribute causality, therefore, to evaluate the effectiveness of an intervention. Sample The study population will be adults with a medical diagnosis of diffuse lung disease, clinically stable, who are under medical treatment (In the original text it said: "in the Polyclinic of Respiratory Diseases", however, due to the sample size obtained, as a team we decided to make a free invitation to those who wish to participate and are under medical treatment in the public or private sector). The sample will be constituted by participants who meet the following eligibility criteria: Inclusion Criteria. * Adults aged 18 years or older. * Medical diagnosis of diffuse interstitial lung disease. * Medical referral to pulmonary rehabilitation according to stability criteria. * Signing of the Informed Consent form. Exclusion Criteria * Neuromotor impairment that prevents independent transfer. * Cognitive deficit preventing him/her from understanding simple instructions. * General contraindications to exercise according to the American College of Sports Medicine. In the sample size calculation, a number of 26 subjects was obtained, considering a significance level of 5%, a power of 80%, an estimated difference between the groups under study of 40 (±35) meters walked in the main response variable, evaluated with the 6-minute Walk Test (De las Heras JC, Hilberg O, Lokke A, Bendstrup E. Tele-rehabilitation program in Idiopathic Pulmonary Fibrosis. European Respiratory Journal. 2019). Considering a 10% loss, the final sample size will be 29 individuals. Evaluation: A set of physical assessments and questionnaires that evaluate the following. functional parameters: * Exercise tolerance * Dyspnea * Health-Related Quality of Life * Limb Muscular Strength * Respiratory Muscular Strength * Pulmonary Function * Functionality * Cognition Training: is the intervention itself and consists of aerobic physical exercise or a combination of 3 modalities: * Aerobic Exercise * Limb Strength Exercise * Respiratory Muscular Strength Exercise All interventions will take place at the Faculty of Medicine of the Universidad de La Frontera, located at Claro Solar 115, and the Laboratory of Physical Fitness and Rehabilitation of the Universidad de La Frontera, located at 18 de Septiembre 525, 6th floor. This research has been approved by the Scientific Ethics Committee of Universidad de La Frontera, Act Number 119\_2024.

Conditions

Interventions

Type	Name	Description
PROCEDURE	Aerobic excersise	20 aerobic exercise sessions, with a duration of 45 to 60 minutes, for 10 weeks.
PROCEDURE	Muscle strength limbs, inspiratory muscle strength	20 sessions of exercise Muscle strength limbs, inspiratory muscle strength, with a duration of 60 minutes, for 10 weeks

Timeline

Start date: 2024-10-01
Primary completion: 2026-05-01
Completion: 2026-09-01
First posted: 2025-07-11
Last updated: 2025-07-11

Locations

1 site across 1 country: Chile

Source: ClinicalTrials.gov record NCT07061873. Inclusion in this directory is not an endorsement.