Interstitial Lung Disease Due to Systemic Disease (Disorder)NCT07061873
Physical Exercise Program for Adults With Diffuse Interstitial Lung Disease in a Pulmonary Rehabilitation Context
A study testing Aerobic excersise and Muscle strength limbs, inspiratory muscle strength in people with Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Universidad de La Frontera at 1 site in Chile.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease in Patients With Rheumatoid Arthritis, Pulmonary Fibrosis
- What is being tested?
- Aerobic excersise and Muscle strength limbs, inspiratory muscle strength
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteChile
- Study dates
- 1 Oct 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
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.
Read the 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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- To describe the functionality in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region.
- 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
- Interstitial Lung Disease Due to Systemic Disease (Disorder), Interstitial Lung Disease in Patients With Rheumatoid Arthritis, Pulmonary Fibrosis
- Being tested
- Aerobic excersise, Muscle strength limbs, inspiratory muscle strength
- Keywords
- ILD, Pulmonary rehabilitation, aerobic excercise, limb strenght, respiratory muscle strenght
- Medical subject headings
- Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic excersiseProcedure or surgery
20 aerobic exercise sessions, with a duration of 45 to 60 minutes, for 10 weeks.
Muscle strength limbs, inspiratory muscle strengthProcedure or surgery
20 sessions of exercise Muscle strength limbs, inspiratory muscle strength, with a duration of 60 minutes, for 10 weeks
| Study group | Role | What they receive |
|---|---|---|
| Control | Other | Control (Aerobic excercise) Receives: Procedure: Aerobic excersise |
| Intervention | Experimental | Intervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise) Receives: Procedure: Aerobic excersise; Procedure: Muscle strength limbs, inspiratory muscle strength |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and then at the end of the 10-week training period
Secondary outcomes (10)
Perceived effort
Corresponds to the subjective feeling of how demanding a physical activity is. It reflects the intensity with which one feels one's body is working, from "very light" to "maximum effort". It is a useful tool for regulating exercise intensity according to the patient's perception. For the purposes of this study, the perception of exertion will be assessed using the Modified Borg Scale from 0 to 10 points, where 0 corresponds to "No dyspnea" and 10 "Very, very severe".
Measured: Baseline and then at the end of the 10-week training period
Dyspnea
Subjective sensation of shortness of breath or difficulty breathing. It may be mild or severe, acute or chronic. It is a frequent symptom of various pulmonary or cardiac conditions, but may also be due to anxiety or intense exercise. To assess Dyspnea, we use the Modified Medical Research Council (mMRC) scale, where 0 is "No shortness of breath except during strenuous exercise" and 4 is "Choking sensation during day-to-day exertion such as getting dressed or going out of the house and need for rest".
Measured: Baseline and then at the end of the 10-week training period
Inspiratory muscle strength
Inspiratory muscle strength is the ability of the respiratory muscles to expand the lungs during inspiration. It is measured by the maximum pressure they can generate when breathing in against resistance. A good level of inspiratory strength is crucial for efficient breathing and good lung health. It will be assessed by an isokinetic valve (PowerBreatheK5), using the best value obtained from 5 attempts, 'for this a continuous scale in cmH2O is used.
Measured: Baseline and then at the end of the 10-week training period
Muscle strenght of limbs
Ability of arm muscles to generate tension and overcome resistance. It is measured by the amount of force they can produce when pushing, pulling or lifting objects. This strength is essential for everyday activities such as walking, lifting, or playing sports. To assess the muscle function of lower limbs, we mesured through the Sit to Stand Test in 1 minute (STST-1m), with the values standardized for Chilean adults by Otto et al.
Measured: Baseline and then at the end of the 10-week training period.
Muscle strenght of arms
Ability of arm muscles to generate tension and overcome resistance. It is measured by the amount of force they can produce when pushing, pulling or lifting objects. This strength is essential for everyday activities such as walking, lifting, or playing sports. To assess the muscle function of arms, it will be evaluated by means of prehensile dynamometry, taking as reference values those established by Romero-Dapueto, et al. for Chilean adults.
Measured: Baseline and then at the end of the 10-week training period
Pulmonary Function
Refers to the ability of the lungs to exchange oxygen and carbon dioxide between air and blood. It involves processes such as ventilation (air inflow and outflow), diffusion (passage of gases) and perfusion (pulmonary blood flow). For this study we will use the Forced Vital Capacity (FVC), the Forced Expiratory Volume in the first second (FEV1) measured in liters, and the ratio between both values (FEV1/FVC) established as a percentage. In addition, the statistical value obtained, according to the reference values of the Global Lung Function Initiative (GLI).
Measured: Baseline and then at the end of the 10-week training period
Treatment Adherence
Extent to which a patient follows his or her physician's recommendations. It involves attending medical appointments and following lifestyle changes. Good adherence is crucial for successful treatment and improved health. Adherence will be measured in relation to the number of sessions the subject completes, i.e. completing the 20 training sessions counts as adherence and a lower number means non-adherence to treatment.
Measured: Baseline and then at the end of the 10-week training period
Adverse Effects
Unwanted reactions that may occur as a result of a treatment, such as the performance of a procedure. They can range from mild to severe. The American College of Sports Medicine has established a series of adverse effects of training, which we have listed and will be checked at each session to assess whether there were adverse effects of training. Among the problems that could occur are the following:
- Injuries
- Overload
- Dehydration
- Cardiovascular problems
- Gastrointestinal problems
- Neuroendocrine problems
- Others (to be noted manually by the trainer)
Measured: Baseline, in each of the training sessions and in the reevaluation.
Functionality
The ability of a system, object or person to perform the functions for which it was designed or adapted. It implies efficiency, utility and fitness for a specific purpose. In people, it refers to the ability to perform activities of daily living and participate in society. this parameter will be evaluated through the Activities of Daily Living Questionnaire (ADLQ-T).
Measured: Baseline and then at the end of the 10-week training period
Cognition
Encompasses the mental processes that make it possible to acquire, process and use information. It includes functions such as attention, memory, language, perception, reasoning and problem solving. It is the basis of knowledge, learning and interaction with the environment. This parameter will be evaluated through the Montreal Cognitive Assessment (MoCA).
Measured: Baseline and then at the end of the 10-week training period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2025
- Study start1 Oct 2024
- Primary completion1 May 2026 (estimated)
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease Due to Systemic Disease (Disorder)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 29 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad de La Frontera
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sayen Huaiquilaf-Jorquera, Universidad de La Frontera
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07061873
- Sponsor's protocol ID
- ECA RP-EPID
- Other IDs
- DI24-011
- Status last verified
- Jul 2025
- First submitted
- 21 Mar 2025
- Last updated
- 11 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Study protocol
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise Program for Adults With Diffuse Interstitial Lung Disease in a Pulmonary Rehabilitation Context
- ClinicalTrials.gov ID
- NCT07061873
- Acronym / sponsor ID
- ECA RP-EPID
- 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
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 29 participants (estimated)
- Lead sponsor
- Universidad de La FronteraUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 11 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- To describe the functionality in users who enter the Pulmonary Rehabilitation program for adults with diffuse interstitial disease in the Araucanía Region.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Other | Procedure: Aerobic excersiseControl (Aerobic excercise) |
| Intervention | Experimental | Procedure: Aerobic excersise, Procedure: Muscle strength limbs, inspiratory muscle strengthIntervention (Muscle strength limbs, inspiratory muscle strength, aerobic exercise) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aerobic excersise20 aerobic exercise sessions, with a duration of 45 to 60 minutes, for 10 weeks. | Procedure or surgery | Control, Intervention |
| Muscle strength limbs, inspiratory muscle strength20 sessions of exercise Muscle strength limbs, inspiratory muscle strength, with a duration of 60 minutes, for 10 weeks | Procedure or surgery | Intervention |
Primary outcome
Exercise tolerance
Time frame: Baseline and then at the end of the 10-week training period
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.
10 secondary outcomes
Perceived effort
Time frame: Baseline and then at the end of the 10-week training period
Dyspnea
Time frame: Baseline and then at the end of the 10-week training period
Inspiratory muscle strength
Time frame: Baseline and then at the end of the 10-week training period
Muscle strenght of limbs
Time frame: Baseline and then at the end of the 10-week training period.
Muscle strenght of arms
Time frame: Baseline and then at the end of the 10-week training period
Pulmonary Function
Time frame: Baseline and then at the end of the 10-week training period
Treatment Adherence
Time frame: Baseline and then at the end of the 10-week training period
Adverse Effects
Time frame: Baseline, in each of the training sessions and in the reevaluation.
Functionality
Time frame: Baseline and then at the end of the 10-week training period
Cognition
Time frame: Baseline and then at the end of the 10-week training period
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2025.
- Web page of School of Medicine Universida de La FronteraLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Study protocol
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic excersise and Muscle strength limbs, inspiratory muscle strength in people with Interstitial Lung Disease Due to Systemic Disease (Disorder) and Interstitial Lung Disease in Patients With Rheumatoid Arthritis, run by Universidad de La Frontera at 1 site in Chile.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 11 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Chile. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Exercise tolerance (time frame: Baseline and then at the end of the 10-week training period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2025.