Lung Disease Interstitial DiffuseNCT07205627
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
A study testing Rehabilitation program in people with Lung Disease Interstitial Diffuse, run by Hospital Civil de Guadalajara at 1 site in Mexico.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Disease Interstitial Diffuse
- What is being tested?
- Rehabilitation program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 25 Sep 2025to 30 Dec 2025
- 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
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mexico1 site
Department of Physical Rehabilitation at the Civil Hospital of Guadalajara
Guadalajara, Jalisco, 44280
Emmanuel Mercado, Fellowship, 3339424400 ext. 43038, emercadonunez@hcg.gob.mx
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Disease Interstitial Diffuse
- Being tested
- Rehabilitation program
- Keywords
- pulmonary rehabilitation, intersticial lung disease, quality of life
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rehabilitation programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Diaphragmatic Index
Variation in diaphragmatic thickness and excursion measured by ultrasound between baseline and after 8 weeks of intervention.
Measured: Baseline and post-intervention (8 weeks).
Secondary outcomes (3)
Change in Quality of Life
Short Form Health Survey or Saint George
Measured: Baseline and post-intervention (8 weeks)
Change in Exercise Tolerance
Improvement in sit to stand test, 6 minutes walking test, Time up and go, and 4 meter gait speed
Measured: Baseline and post-intervention (8 weeks)
Change in Dyspnea Perception
Modified Borg Scale (0-10) or mMRC Dyspnea Scale.
Measured: Baseline and post-intervention (8 weeks).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2025
- Study start25 Sep 2025 (estimated)
- Primary completion1 Dec 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lung Disease Interstitial DiffuseStudies 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
- Non-randomised
- Intervention model
- Single group
- Model description
- 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
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Civil de Guadalajara
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emmanuel Mercado Nuñez, Hospital Civil de Guadalajara
- Investigators
- Armando Tonatiuh Avila Garcia, Master Degree, Study director, Hospital Civil de Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07205627
- Sponsor's protocol ID
- CEI 1167/25
- Status last verified
- Sep 2025
- First submitted
- 25 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The study involves a small sample size, and data are considered sensitive. Only aggregated results will be shared in publications and reports.
Publications
Kataoka K, Nishiyama O, Ogura T, Mori Y, Kozu R, Arizono S, Tsuda T, Tomioka H, Tomii K, Sakamoto K, Ishimoto H, Kagajo M, Ito H, Ichikado K, Sasano H, Eda S, Arita M, Goto Y, Hataji O, Fuke S, Shintani R, Hasegawa H, Ando M, Ogawa T, Shiraishi M, Watanabe F, Nishimura K, Sasaki T, Miyazaki S, Saka H, Kondoh Y; FITNESS study Collaborators. Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial. Thorax. 2023 Aug;78(8):784-791. doi: 10.1136/thorax-2022-219792. Epub 2023 Apr 3.
PubMed 37012071Dowman LM, Holland AE. Pulmonary rehabilitation in idiopathic pulmonary fibrosis. Curr Opin Pulm Med. 2024 Sep 1;30(5):516-522. doi: 10.1097/MCP.0000000000001094. Epub 2024 Jul 3.
PubMed 38958566Shen L, Zhang Y, Su Y, Weng D, Zhang F, Wu Q, Chen T, Li Q, Zhou Y, Hu Y, Jiang X, Jin X, Zhang A, Li H. New pulmonary rehabilitation exercise for pulmonary fibrosis to improve the pulmonary function and quality of life of patients with idiopathic pulmonary fibrosis: a randomized control trial. Ann Palliat Med. 2021 Jul;10(7):7289-7297. doi: 10.21037/apm-21-71.
PubMed 34353031Bahmer T, Kirsten AM, Waschki B, Rabe KF, Magnussen H, Kirsten D, Gramm M, Hummler S, Brunnemer E, Kreuter M, Watz H. Prognosis and longitudinal changes of physical activity in idiopathic pulmonary fibrosis. BMC Pulm Med. 2017 Jul 25;17(1):104. doi: 10.1186/s12890-017-0444-0.
PubMed 28743305Troy LK, Young IH, Lau EM, Corte TJ. Exercise pathophysiology and the role of oxygen therapy in idiopathic interstitial pneumonia. Respirology. 2016 Aug;21(6):1005-14. doi: 10.1111/resp.12650. Epub 2015 Sep 29.
PubMed 26416262Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
PubMed 24127811Capparelli I, Fernandez M, Saadia Otero M, Steimberg J, Brassesco M, Campobasso A, Palacios S, Caro F, Alberti ML, Rabinovich RA, Paulin F. Translation to Spanish and Validation of the Specific Saint George's Questionnaire for Idiopathic Pulmonary Fibrosis. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):68-73. doi: 10.1016/j.arbres.2017.09.004. Epub 2017 Nov 2. English, Spanish.
PubMed 29102341Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.
PubMed 30236104Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.
PubMed 34559419Fernandez ME, Capparelli I, Bonet DB. [Pulmonary Rehabilitation in ILD patients, a comprehensive intervention]. Open Respir Arch. 2021 Mar 24;3(1):100090. doi: 10.1016/j.opresp.2021.100090. eCollection 2021 Jan-Mar. No abstract available. Spanish.
PubMed 37497356Martínez-Briseño, David, García-Sancho, Cecilia, Fernández-Plata, Rosario, Franco-Marina, Francisco, Torre-Bouscuolet, Luis, & Pérez-Padilla, José Rogelio. (2014). Tendencia de la mortalidad por enfermedades intersticiales en México, período 2000-2010. Neumología y cirugía de tórax, 73(3), 179-184. Recuperado en 25 de septiembre de 2025, de http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0028-37462014000300004&lng=es&tlng=es.
Perez-Padilla JR, Thirion-Romero I, Robles-Hernandez R, Cagney J, Razo C, Rios-Blancas MJ. Respiratory diseases in Mexico: analysis from the Global Burden of Disease study 2021. Gac Med Mex. 2023;159(6):582-595. doi: 10.24875/GMM.M24000840.
PubMed 38386883Althobiani MA, Russell AM, Jacob J, Ranjan Y, Folarin AA, Hurst JR, Porter JC. Interstitial lung disease: a review of classification, etiology, epidemiology, clinical diagnosis, pharmacological and non-pharmacological treatment. Front Med (Lausanne). 2024 Apr 18;11:1296890. doi: 10.3389/fmed.2024.1296890. eCollection 2024.
PubMed 38698783Santana PV, Cardenas LZ, de Albuquerque ALP, de Carvalho CRR, Caruso P. Diaphragmatic ultrasound findings correlate with dyspnea, exercise tolerance, health-related quality of life and lung function in patients with fibrotic interstitial lung disease. BMC Pulm Med. 2019 Oct 21;19(1):183. doi: 10.1186/s12890-019-0936-1.
PubMed 31638951
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07205627
- Acronym / sponsor ID
- CEI 1167/25
- Conditions
- Lung Disease Interstitial Diffuse
- Keywords
- pulmonary rehabilitation, intersticial lung disease, quality of life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Civil de GuadalajaraUniversity, hospital or other
- Study start
- 25 Sep 2025 (estimated)
- Primary completion
- 1 Dec 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 3 Oct 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.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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
| Arm | Type | Receives |
|---|---|---|
| Rehabilitation program | Experimental | Other: Rehabilitation programType 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| Rehabilitation programParticipants 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. | Other | Rehabilitation program |
Primary outcome
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.
3 secondary outcomes
Change in Quality of Life
Time frame: Baseline and post-intervention (8 weeks)
Change in Exercise Tolerance
Time frame: Baseline and post-intervention (8 weeks)
Change in Dyspnea Perception
Time frame: Baseline and post-intervention (8 weeks).
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 3 Oct 2025.
- Background: PubMed 37012071Kataoka K, Nishiyama O, Ogura T, Mori Y, Kozu R, Arizono S, Tsuda T, Tomioka H, Tomii K, Sakamoto K, Ishimoto H, Kagajo M, Ito H, Ichikado K, Sasano H, Eda S, Arita M, Goto Y, Hataji O, Fuke S, Shintani R, Hasegawa H, Ando M, Ogawa T, Shiraishi M, Watanabe F, Nishimura K, Sasaki T, Miyazaki S, Saka H, Kondoh Y; FITNESS study Collaborators. Long-term effect of pulmonary rehabilitation in idiopathic pulmonary fibrosis: a randomised controlled trial. Thorax. 2023 Aug;78(8):784-791. doi: 10.1136/thorax-2022-219792. Epub 2023 Apr 3.
- Background: PubMed 38958566Dowman LM, Holland AE. Pulmonary rehabilitation in idiopathic pulmonary fibrosis. Curr Opin Pulm Med. 2024 Sep 1;30(5):516-522. doi: 10.1097/MCP.0000000000001094. Epub 2024 Jul 3.
- Background: PubMed 34353031Shen L, Zhang Y, Su Y, Weng D, Zhang F, Wu Q, Chen T, Li Q, Zhou Y, Hu Y, Jiang X, Jin X, Zhang A, Li H. New pulmonary rehabilitation exercise for pulmonary fibrosis to improve the pulmonary function and quality of life of patients with idiopathic pulmonary fibrosis: a randomized control trial. Ann Palliat Med. 2021 Jul;10(7):7289-7297. doi: 10.21037/apm-21-71.
- Background: PubMed 28743305Bahmer T, Kirsten AM, Waschki B, Rabe KF, Magnussen H, Kirsten D, Gramm M, Hummler S, Brunnemer E, Kreuter M, Watz H. Prognosis and longitudinal changes of physical activity in idiopathic pulmonary fibrosis. BMC Pulm Med. 2017 Jul 25;17(1):104. doi: 10.1186/s12890-017-0444-0.
- Background: PubMed 26416262Troy LK, Young IH, Lau EM, Corte TJ. Exercise pathophysiology and the role of oxygen therapy in idiopathic interstitial pneumonia. Respirology. 2016 Aug;21(6):1005-14. doi: 10.1111/resp.12650. Epub 2015 Sep 29.
- Background: PubMed 24127811Spruit MA, Singh SJ, Garvey C, ZuWallack R, Nici L, Rochester C, Hill K, Holland AE, Lareau SC, Man WD, Pitta F, Sewell L, Raskin J, Bourbeau J, Crouch R, Franssen FM, Casaburi R, Vercoulen JH, Vogiatzis I, Gosselink R, Clini EM, Effing TW, Maltais F, van der Palen J, Troosters T, Janssen DJ, Collins E, Garcia-Aymerich J, Brooks D, Fahy BF, Puhan MA, Hoogendoorn M, Garrod R, Schols AM, Carlin B, Benzo R, Meek P, Morgan M, Rutten-van Molken MP, Ries AL, Make B, Goldstein RS, Dowson CA, Brozek JL, Donner CF, Wouters EF; ATS/ERS Task Force on Pulmonary Rehabilitation. An official American Thoracic Society/European Respiratory Society statement: key concepts and advances in pulmonary rehabilitation. Am J Respir Crit Care Med. 2013 Oct 15;188(8):e13-64. doi: 10.1164/rccm.201309-1634ST.
- Background: PubMed 29102341Capparelli I, Fernandez M, Saadia Otero M, Steimberg J, Brassesco M, Campobasso A, Palacios S, Caro F, Alberti ML, Rabinovich RA, Paulin F. Translation to Spanish and Validation of the Specific Saint George's Questionnaire for Idiopathic Pulmonary Fibrosis. Arch Bronconeumol (Engl Ed). 2018 Feb;54(2):68-73. doi: 10.1016/j.arbres.2017.09.004. Epub 2017 Nov 2. English, Spanish.
- Background: PubMed 30236104Perez-Bogerd S, Wuyts W, Barbier V, Demeyer H, Van Muylem A, Janssens W, Troosters T. Short and long-term effects of pulmonary rehabilitation in interstitial lung diseases: a randomised controlled trial. Respir Res. 2018 Sep 20;19(1):182. doi: 10.1186/s12931-018-0884-y.
- Background: PubMed 34559419Dowman L, Hill CJ, May A, Holland AE. Pulmonary rehabilitation for interstitial lung disease. Cochrane Database Syst Rev. 2021 Feb 1;2(2):CD006322. doi: 10.1002/14651858.CD006322.pub4.
- Background: PubMed 37497356Fernandez ME, Capparelli I, Bonet DB. [Pulmonary Rehabilitation in ILD patients, a comprehensive intervention]. Open Respir Arch. 2021 Mar 24;3(1):100090. doi: 10.1016/j.opresp.2021.100090. eCollection 2021 Jan-Mar. No abstract available. Spanish.
- BackgroundMartínez-Briseño, David, García-Sancho, Cecilia, Fernández-Plata, Rosario, Franco-Marina, Francisco, Torre-Bouscuolet, Luis, & Pérez-Padilla, José Rogelio. (2014). Tendencia de la mortalidad por enfermedades intersticiales en México, período 2000-2010. Neumología y cirugía de tórax, 73(3), 179-184. Recuperado en 25 de septiembre de 2025, de http://www.scielo.org.mx/scielo.php?script=sci_arttext&pid=S0028-37462014000300004&lng=es&tlng=es.
- Background: PubMed 38386883Perez-Padilla JR, Thirion-Romero I, Robles-Hernandez R, Cagney J, Razo C, Rios-Blancas MJ. Respiratory diseases in Mexico: analysis from the Global Burden of Disease study 2021. Gac Med Mex. 2023;159(6):582-595. doi: 10.24875/GMM.M24000840.
- Individual participant dataSharing planned: No. The study involves a small sample size, and data are considered sensitive. Only aggregated results will be shared in publications and reports.
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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.
Armando Tonatiuh Avila Garcia, Master Degree study director
Hospital Civil de Guadalajara
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Rehabilitation program in people with Lung Disease Interstitial Diffuse, run by Hospital Civil de Guadalajara at 1 site in Mexico.
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 5 inclusion and 5 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: opening soon, as of the sponsor's last update on 3 Oct 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 Mexico. 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?
Contact Emmanuel Mercado Nuñez Dr- Mercado, Fellowship (+52 3330584121, emercadonunez@hcg.gob.mx), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Diaphragmatic Index (time frame: Baseline and post-intervention (8 weeks).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07205627, which also lists 14 linked publications.
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 3 Oct 2025.