Systemic Sclerosis Associated Interstitial Lung DiseaseNCT06105073
"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"
An observational study of Systemic Sclerosis Associated Interstitial Lung Disease, run by Coordinación de Investigación en Salud, Mexico at 1 site in Mexico.
Trial summary
Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Systemic Sclerosis Associated Interstitial Lung Disease
- What is being tested?
- Pulmonary Rehabilitation Program
- Type of treatment
- Surgery or procedure
- How many people
- 67 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2022to 1 Mar 2024
- How long will I take part?
- 12 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who come to the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis from the National Medical Center La Raza IMSS
Who may be able to join
- Confirmed diagnosis of SSc, determined by the treating rheumatology service either from the Rheumatology and/or Internal Medicine Service of the Specialty Hospital of the National Medical Center La Raza IMSS , based on the ACR/EULAR 2013 criteria for SSc.
- Time of evolution of the disease indistinct. You can be treated with any of the drugs in the spectrum of autoimmune disease treatment (immunosuppressants, steroids, biologics, etc.).
- Diagnosis of Interstitial Lung Disease associated with SSc, confirmed by HRCT and FVC < 80% or TLC < 80% or DLCO < 80%.
Who cannot join
- Pregnant
- Chest, abdominal pain, oral or facial pain that prevents using the mouthpiece or forced expiration.
- Stress incontinence, dementia or confusion.
- Who have contraindications for performing physical effort.
- Oxygen dependence that does not allow its withdrawal for more than 10 minutes.
- Recent surgeries less than 1 month in case of thorax and upper abdomen and less than three months in case of retina and middle ear surgery.
Show all 10Show fewer
- Belonging to vulnerable groups (homeless people, prisoners, etc.)
- Failure to obtain the informed consent signature
- Presence of contraindication to exercise such as muscular or orthopedic injuries.
- Who have presented disease activity data that would have required a change in pharmacological treatment in a period of less than 12 weeks prior to the start of the rehabilitation program.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Centro Medico Nacional La Raza
Mexico City, 02990
Maria del Pilar Cruz Dominguez, +52 55 5724 5900 ext. 8200, drpilarcd@gmail.com
Nancy Fernandez Figueroa, +52 55 5724 5900 ext. 23440, dra.fabiolafdzneumologia@gmail.com
About this study
Official title: "Effect of a Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis on Oxygen Consumption, Functionality, and Quality of Life"
Interstitial Lung Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung
The main question it aims to answer are:
Read more
What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36.
Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.
Read the detailed description
Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis, at the Speciality Hospital from the National Medical Center La Raza IMSS, all patients who wish to participate in the study will be asked to sign the informed consent letter from the participating researchers, subsequently the anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, as well as history of smoking, occupational and environmental exposures to both biomass combustion smoke and inorganic powders, these questionnaires are validated in our population and have been widely used, the data corresponding to the time of evolution of the disease, medications used, comorbidities and levels of antibodies and acute phase reactants will be collected from the clinical records. of each of the participants. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity (DLCO) and Cardiopulmonary Exercise Test. The Pulmonary Function Laboratory of the National Medical Center General Hospital has qualified and trained personnel in performing respiratory function tests, the interpretation of said results will be carried out by the main author (doctoral student) who has a high specialty in Respiratory Physiology and Pulmonary Function Laboratory. Subsequently, the patients will be sent to the Pulmonary Rehabilitation service of the La Raza National Medical Center where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, plethysmography, DLCO, arterial blood gases and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires. The protocol has been submitted for approval to the National Health Research Committee (CNCI).
Study procedures. Every day prior to the start of the work day in the Pulmonary Function Laboratory of the National Medical Center La Raza IMSS, the cleaning and disinfection procedures of the equipment are carried out according to the manufacturer's requirements and the procedures are carried out. calibration, both for volume and flow linearity according to ATS/ERS 2005 standards for flow sensors, as well as linearity calibrations for the gas analyzer and pressure and temperature calibrations of the equipment.
Prior to performing the lung function tests, anthropometric measurements will be performed as follows:
- Height: with the patient in a standing position, height will be obtained with a wall stadiometer model 206 (Seca GMBH \& Co., Hamburg, Germany). This measurement will be carried out by placing the heels together, close to the wall, as well as the calves, buttocks, shoulder blades and head. The head will be positioned by asking the patient to look forward, keeping the lateral canthus of the orbit horizontal in relation to the auditory meatus (Frankfort plane).
- Weight: with the patient wearing light clothing, the weight will be obtained using a precision digital scale model 813 (Seca GMBH \& Co., Hamburg, Germany).
Goldberg Questionnaire for Anxiety and Depression The Goldberg Anxiety and Depression Scale is both a screening test, with healthcare and epidemiological uses, and an interview guide. It is a test that not only guides the diagnosis towards anxiety or depression (or both in mixed cases), but also discriminates between them and measures their respective intensities.
The Goldberg Anxiety and Depression Scale contains 2 subscales with nine questions in each: anxiety subscale (questions 1-9) and depression subscale (questions 10-18). The first 4 questions of each subscale (questions 1-4) and (questions 10-13), respectively, act as a precondition to determine whether the rest of the questions should be attempted. Specifically, if a minimum of 2 questions from questions 1-4 are not answered affirmatively, the rest of the questions in the first subscale should not be answered, while in the case of the second subscale it is sufficient to answer affirmatively to one question. between questions 10-13 to be able to proceed to answer the rest of the questions.
The cut-off points are 4 or more for the anxiety subscale and 2 or more for the depression subscale, with scores being higher the more serious the problem is (the maximum possible being 9 in each of the subscales). Even when the questions are very clear, the answers only admit dichotomy, so that sometimes, when coincidences of slight intensity are involved, the judgment of a specialist professional is necessary to assess the clinical significance of the answer.
SF-36 Questionnaire This questionnaire contains 36 items to measure health in eight dimensions: perception of general health, physical and social functioning, limitations of function due to physical or emotional problems, health, vitality and body pain. For each dimension, items are coded, summed, and transformed into a scale from 0 (worst health) to 100 (best health). The eight dimensions can be reduced to two summary measures, a physical component score (PCS) and a mental component score (MCS). The MCID in brief form 36 (SF-36) has been estimated in patients with rheumatoid arthritis which has been estimated at 20% improvement in baseline score.
SySQ Questionnaire. It is a self-administered functionality questionnaire for SSc (Systemic Sclerosis Questionnaire [SySQ]), which assesses the difficulty in carrying out activities of daily living and the intensity and frequency of the symptoms with the greatest functional impact in SSc. This instrument was originally designed in German and has been validated in Spanish by this working group. Include 3 domains concerning activities of daily living, intensity and frequency of symptoms. Three domains in 4 categories: 1) general symptoms; 2) musculoskeletal symptoms; 3) cardiopulmonary symptoms, and 4) symptoms of the digestive tract, which are the main organs affected and represent the greatest impact on the functionality of patients with Ssc. This scale includes an ability to perform an action section (0 = no difficulty, 1 = some difficulty, 2 = some difficulty, 3 = unable to do); another section describes the intensity of the symptoms (0 = no, 1 = mild, 2 = moderate, 3 = very severe), and finally there is a section on the frequency of the symptoms (0 = no, 1 = sometimes, 2 = often, 3 = always). The final score of the scale is calculated by averaging the maximum value obtained in each domain (block of questions) divided by 3 (given that there are 3 domains), and that value goes from 0 (normal functionality) to 3 (minimal functionality). The questionnaire formats will be provided by the pulmonary function laboratory staff to the study participants.
Forced spirometry. Spirometry is the main test of respiratory function, it evaluates respiratory mechanics and is the standard for diagnosing bronchial obstruction. The test was performed in accordance with ATS/ERS 2005 standards. Once the patient is prepared for the test, the patient is instructed about the procedure. It is explained to him that he will be sitting (preferably in a fixed chair with arm support), with his trunk upright and his head slightly elevated; He is instructed to place a mouthpiece and a nose clip in his mouth and to perform a maximum inhalation and then an exhalation with an explosive and sustained onset. The maneuver will be carried out in a closed circuit. The patient will be asked to maintain forced expiration for at least 6 seconds until reaching a plateau of at least 1 second. The available equipment is the brand and model Jaeger Sentry Suite Ver. 2.13, IOS, Germany.
Carbon monoxide diffusing capacity (DLCO) This test is necessary to evaluate gas transfer, it is necessary to complement the diagnosis and rule out interstitial damage in patients who present restriction of extrapulmonary origin. The test will be performed according to ATS/ERS 2017 standards. The patient will be seated (fixed chair with arm support), with the trunk upright and the head slightly elevated. You will be fitted with a nose clip and asked to breathe into the equipment through a sterile antibacterial mouthpiece. At the beginning, breaths were performed in tidal volume and later, based on residual functional capacity, a maximum expiration was made, until reaching a plateau of 1 second and reaching residual volume. When the residual volume was reached, the valves were activated. The patient was encouraged to perform maximum and rapid inspiration (less than 3 seconds), which reached more than 90% of his vital capacity. He must maintain an apnea for 10 seconds, taking care that there are no leaks or valsalva maneuver. The patient was instructed to make a maximum expiration, but slowly and relaxed, lasting longer than 4 seconds. The time between maneuvers was at least 4 minutes. A minimum of two efforts were completed with acceptability criteria in accordance with ATS/ERS 2017. The available equipment is the brand and model Jaeger Sentry Suite Ver. 2.13, Germany. Exercise test.
- Being tested
- Pulmonary Rehabilitation Program
- Keywords
- Systemic sclerosis, Interstitial lung disease, Pulmonary rehabilitation program, Quality of life, Oxygen consumption, Functionality
- Medical subject headings
- Scleroderma, Systemic, Lung Diseases, Interstitial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary Rehabilitation ProgramProcedure or surgery
Consecutive patients who attend with a confirmed diagnosis of Systemic Sclerosis associated Interstitial Lung disease, at the Speciality Hospital from the Medical Center La Raza IMSS. The anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, these questionnaires are validated in our population and have been widely used. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test. Then they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, DLCO and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires.
| Study group | Role | What they receive |
|---|---|---|
| Patients whit Systemic Sclerosis asociated Interstitial Lung Disease | Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis associated Interstitial Lung disease, from the Medical Center, La Raza IMSS. Receives: Procedure: Pulmonary Rehabilitation Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oxygen consumption peak
Change in oxygen consumption of at least 1.15 ml/kg/min relative to the measurement before receiving the supervised pulmonary rehabilitation program, measured in ml/min.
Measured: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks), estimated by cardiopulmonary exercise test
Quality of life health related
Change in the score obtained in the SF36 quality of life questionnaire of at least 20% in relation to the baseline score obtained before receiving the 12-week supervised pulmonary rehabilitation program. Where 0 is the worst quality of life and 100 is the best quality of life, scores below 50 are considered poor quality of life.
Measured: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Functionality
Change of 1 category in the score of the functionality scale for systemic sclerosis SySQ, in relation to the score obtained before entering the 12-week supervised pulmonary rehabilitation program.
This scale includes an ability to perform an action section (0 = no difficulty, 1 = some difficulty, 2 = some difficulty, 3 = unable to do); another section describes the intensity of the symptoms (0 = no, 1 = mild, 2 = moderate, 3 = very severe), and finally there is a section on the frequency of the symptoms (0 = no, 1 = sometimes, 2 = often, 3 = always). The final score of the scale is calculated by averaging the maximum value obtained in each domain (block of questions) divided by 3 (given that there are 3 domains), and that value goes from 0 (normal functionality) to 3 (minimal functionality)
Measured: t will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2023
- Study start1 Mar 2022
- Primary completion1 Mar 2023
- Study completion1 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Systemic Sclerosis Associated Interstitial Lung DiseaseStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 67 participants (estimated)
- Target duration
- 12 Weeks
Sponsor and investigators
- Lead sponsor
- Coordinación de Investigación en Salud, Mexico
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06105073
- Sponsor's protocol ID
- CNCI-R-2021-785-064
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 2 Feb 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424.
PubMed 24092682Steele R, Hudson M, Lo E, Baron M; Canadian Scleroderma Research Group. Clinical decision rule to predict the presence of interstitial lung disease in systemic sclerosis. Arthritis Care Res (Hoboken). 2012 Apr;64(4):519-24. doi: 10.1002/acr.21583.
PubMed 22213733Nihtyanova SI, Schreiber BE, Ong VH, Rosenberg D, Moinzadeh P, Coghlan JG, Wells AU, Denton CP. Prediction of pulmonary complications and long-term survival in systemic sclerosis. Arthritis Rheumatol. 2014 Jun;66(6):1625-35. doi: 10.1002/art.38390.
PubMed 24591477Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017 Oct 7;390(10103):1685-1699. doi: 10.1016/S0140-6736(17)30933-9. Epub 2017 Apr 13.
PubMed 28413064Suliman YA, Dobrota R, Huscher D, Nguyen-Kim TD, Maurer B, Jordan S, Speich R, Frauenfelder T, Distler O. Brief Report: Pulmonary Function Tests: High Rate of False-Negative Results in the Early Detection and Screening of Scleroderma-Related Interstitial Lung Disease. Arthritis Rheumatol. 2015 Dec;67(12):3256-61. doi: 10.1002/art.39405.
PubMed 26316389Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264. Epub 2010 Jun 15.
PubMed 20551155Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. Epub 2016 Nov 9.
PubMed 27941129Willems LM, Vriezekolk JE, Schouffoer AA, Poole JL, Stamm TA, Bostrom C, Kwakkenbos L, Vliet Vlieland TP, van den Ende CH. Effectiveness of Nonpharmacologic Interventions in Systemic Sclerosis: A Systematic Review. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1426-39. doi: 10.1002/acr.22595.
PubMed 25832447Avouac J, Walker U, Tyndall A, Kahan A, Matucci-Cerinic M, Allanore Y; EUSTAR; Miniati I, Muller A, Iannone F, Distler O, Becvar R, Sierakowsky S, Kowal-Bielecka O, Coelho P, Cabane J, Cutolo M, Shoenfeld Y, Valentini G, Rovensky J, Riemekasten G, Vlachoyiannopoulos P, Caporali R, Jiri S, Inanc M, Zimmermann Gorska I, Carreira P, Novak S, Czirjak L, Oliveira Ramos F, Jendro M, Chizzolini C, Kucharz EJ, Richter J, Cozzi F, Rozman B, Mallia CM, Gabrielli A, Farge D, Kiener HP, Schoffel D, Airo P, Wollheim F, Martinovic D, Trotta F, Jablonska S, Reich K, Bombardieri S, Siakka P, Pellerito R, Bambara LM, Morovic-Vergles J, Denton C, Hinrichs R, Van den Hoogen F, Damjanov N, Kotter I, Ortiz V, Heitmann S, Krasowska D, Seidel M, Hasler P, Van Laar JM, Kaltwasser JP, Foeldvari I, Juan Mas A, Bajocchi G, Wislowska M, Pereira Da Silva JA, Jacobsen S, Worm M, Graniger W, Kuhn A, Stankovic A, Cossutta R, Majdan M, Damjanovska Rajcevska L, Tikly M, Nasonov EL, Steinbrink K, Herrick A, Muller-Ladner U, Dinc A, Scorza R, Sondergaard K, Indiveri F, Nielsen H, Szekanecz Z, Silver RM, Antivalle M, Espinosa IB, Garcia de la Pena Lefebvre P, Midtvedt O, Launay D, Valesini F, Tuvik P, Ionescu RM, Del Papa N, Pinto S, Wigley F, Mihai C, Sinziana Capranu M, Sunderkotter C, Jun JB, Alhasani S, Distler JH, Ton E, Soukup T, Seibold J, Zeni S, Nash P, Mouthon L, De Keyser F, Duruoz MT, Cantatore FP, Strauss G, von Mulhen CA, Pozzi MR, Eyerich K, Szechinski J, Keiserman M, Houssiau FA, Roman-Ivorra JA, Krummel-Lorenz B, Aringer M, Westhovens R, Bellisai F, Mayer M, Stoeckl F, Uprus M, Volpe A, Buslau M, Yavuz S, Granel B, Valderilio Feijo A, Del Galdo F, Popa S, Zenone T, Ricardo Machado X, Pileckyte M, Stebbings S, Mathieu A, Tulli A, Tourinho T, Souza R, Acayaba de Toledo R, Stamp L, Solanki K, Veale D, Francisco Marques Neto J, Bagnato GF, Loyo E, Toloza S, Li M, Ahmed Abdel Atty Mohamed W, Cobankara V, Olas J, Salsano F, Oksel F, Tanaseanu CM, Foti R, Ancuta C, Vonk M, Caramashi P, Beretta L, Balbir A, Chiala A, Pasalic Simic K, Ghio M, Stamenkovic B, Rednic S, Host N, Pellerito R, Hachulla E, Furst DE. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database. J Rheumatol. 2010 Jul;37(7):1488-501. doi: 10.3899/jrheum.091165. Epub 2010 Jun 15.
PubMed 20551097Clements PJ, Furst DE, Campion DS, Bohan A, Harris R, Levy J, Paulus HE. Muscle disease in progressive systemic sclerosis: diagnostic and therapeutic considerations. Arthritis Rheum. 1978 Jan-Feb;21(1):62-71. doi: 10.1002/art.1780210111.
PubMed 623695Lima TR, Guimaraes FS, Carvalho MN, Sousa TL, Menezes SL, Lopes AJ. Lower limb muscle strength is associated with functional performance and quality of life in patients with systemic sclerosis. Braz J Phys Ther. 2015 Mar-Apr;19(2):129-36. doi: 10.1590/bjpt-rbf.2014.0084. Epub 2015 Mar 13.
PubMed 25789555Blom-Bulow B, Jonson B, Bauer K. Factors limiting exercise performance in progressive systemic sclerosis. Semin Arthritis Rheum. 1983 Nov;13(2):174-81. doi: 10.1016/0049-0172(83)90004-5.
PubMed 6673113Cuomo G, Santoriello C, Polverino F, Ruocco L, Valentini G, Polverino M. Impaired exercise performance in systemic sclerosis and its clinical correlations. Scand J Rheumatol. 2010 Aug;39(4):330-5. doi: 10.3109/03009740903555358.
PubMed 20476863de Oliveira NC, dos Santos Sabbag LM, Ueno LM, de Souza RB, Borges CL, de Sa Pinto AL, Lima FR. Reduced exercise capacity in systemic sclerosis patients without pulmonary involvement. Scand J Rheumatol. 2007 Nov-Dec;36(6):458-61. doi: 10.1080/03009740701605889.
PubMed 18092268Hudson M, Thombs BD, Steele R, Panopalis P, Newton E, Baron M; Canadian Scleroderma Research Group. Health-related quality of life in systemic sclerosis: a systematic review. Arthritis Rheum. 2009 Aug 15;61(8):1112-20. doi: 10.1002/art.24676.
PubMed 19644906
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Effect of a Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis on Oxygen Consumption, Functionality, and Quality of Life"
- ClinicalTrials.gov ID
- NCT06105073
- Acronym / sponsor ID
- CNCI-R-2021-785-064
- Keywords
- Systemic sclerosis, Interstitial lung disease, Pulmonary rehabilitation program, Quality of life, Oxygen consumption, Functionality
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 67 participants (estimated)
- Lead sponsor
- Coordinación de Investigación en Salud, MexicoOther government
- Study start
- 1 Mar 2022 (actual)
- Primary completion
- 1 Mar 2023 (actual)
- Study completion
- 1 Mar 2024 (estimated)
- First posted
- 27 Oct 2023 (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 Disease associated with Systemic Sclerosis currently represents the main cause of death in this disease, it is also the cause of significant morbidity, which is why pulmonary rehabilitation strategies can be of great benefit in this group of patients. The aim of this study is to determine the effect of a 36-session supervised pulmonary rehabilitation program compared before and after, on oxygen consumption, functionality, and quality of life in Interstitial Lung
The main question it aims to answer are:
What effect will have with a 36-session supervised pulmonary rehabilitation program, compared before and after, on oxygen consumption, functionality and quality of life in Interstitial Lung Disease associated with Systemic Sclerosis, estimated by Cardiopulmonary Exercise Test, the questionnaire self-administered SySQ (systemic sclerosis functionality questionnaire) and the self-administered questionnaire SF-36.
Disease associated with Systemic Sclerosis. Study design: Quasi-experimental, longitudinal, comparative before and after study. Methods: Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis, at the Speciality Hospital of the National Medical Center La raza IMSS (Mexican Institute of Social Security), all those patients who wish to participate in the study will be asked to sign the informed consent letter, subsequently the Goldberg anxiety and depression questionnaire will be applied, as well as the SF-36 questionnaire to evaluate quality of life and SySQ to evaluate functionality, all participants will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test, the Pulmonary Function laboratory of the General Hospital National Medical Center La Raza IMSS . Subsequently, they will be sent to the Pulmonary Rehabilitation service, where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions (12 weeks). After the end of the program, respiratory function tests and tests will be performed again questionnaires, pulmonary function tests and cardiopulmonary exercise test.
Detailed description
Consecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis, at the Speciality Hospital from the National Medical Center La Raza IMSS, all patients who wish to participate in the study will be asked to sign the informed consent letter from the participating researchers, subsequently the anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, as well as history of smoking, occupational and environmental exposures to both biomass combustion smoke and inorganic powders, these questionnaires are validated in our population and have been widely used, the data corresponding to the time of evolution of the disease, medications used, comorbidities and levels of antibodies and acute phase reactants will be collected from the clinical records. of each of the participants. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity (DLCO) and Cardiopulmonary Exercise Test. The Pulmonary Function Laboratory of the National Medical Center General Hospital has qualified and trained personnel in performing respiratory function tests, the interpretation of said results will be carried out by the main author (doctoral student) who has a high specialty in Respiratory Physiology and Pulmonary Function Laboratory. Subsequently, the patients will be sent to the Pulmonary Rehabilitation service of the La Raza National Medical Center where they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, plethysmography, DLCO, arterial blood gases and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires. The protocol has been submitted for approval to the National Health Research Committee (CNCI).
Study procedures. Every day prior to the start of the work day in the Pulmonary Function Laboratory of the National Medical Center La Raza IMSS, the cleaning and disinfection procedures of the equipment are carried out according to the manufacturer's requirements and the procedures are carried out. calibration, both for volume and flow linearity according to ATS/ERS 2005 standards for flow sensors, as well as linearity calibrations for the gas analyzer and pressure and temperature calibrations of the equipment.
Prior to performing the lung function tests, anthropometric measurements will be performed as follows:
- Height: with the patient in a standing position, height will be obtained with a wall stadiometer model 206 (Seca GMBH \& Co., Hamburg, Germany). This measurement will be carried out by placing the heels together, close to the wall, as well as the calves, buttocks, shoulder blades and head. The head will be positioned by asking the patient to look forward, keeping the lateral canthus of the orbit horizontal in relation to the auditory meatus (Frankfort plane).
- Weight: with the patient wearing light clothing, the weight will be obtained using a precision digital scale model 813 (Seca GMBH \& Co., Hamburg, Germany).
Goldberg Questionnaire for Anxiety and Depression The Goldberg Anxiety and Depression Scale is both a screening test, with healthcare and epidemiological uses, and an interview guide. It is a test that not only guides the diagnosis towards anxiety or depression (or both in mixed cases), but also discriminates between them and measures their respective intensities.
The Goldberg Anxiety and Depression Scale contains 2 subscales with nine questions in each: anxiety subscale (questions 1-9) and depression subscale (questions 10-18). The first 4 questions of each subscale (questions 1-4) and (questions 10-13), respectively, act as a precondition to determine whether the rest of the questions should be attempted. Specifically, if a minimum of 2 questions from questions 1-4 are not answered affirmatively, the rest of the questions in the first subscale should not be answered, while in the case of the second subscale it is sufficient to answer affirmatively to one question. between questions 10-13 to be able to proceed to answer the rest of the questions.
The cut-off points are 4 or more for the anxiety subscale and 2 or more for the depression subscale, with scores being higher the more serious the problem is (the maximum possible being 9 in each of the subscales). Even when the questions are very clear, the answers only admit dichotomy, so that sometimes, when coincidences of slight intensity are involved, the judgment of a specialist professional is necessary to assess the clinical significance of the answer.
SF-36 Questionnaire This questionnaire contains 36 items to measure health in eight dimensions: perception of general health, physical and social functioning, limitations of function due to physical or emotional problems, health, vitality and body pain. For each dimension, items are coded, summed, and transformed into a scale from 0 (worst health) to 100 (best health). The eight dimensions can be reduced to two summary measures, a physical component score (PCS) and a mental component score (MCS). The MCID in brief form 36 (SF-36) has been estimated in patients with rheumatoid arthritis which has been estimated at 20% improvement in baseline score.
SySQ Questionnaire. It is a self-administered functionality questionnaire for SSc (Systemic Sclerosis Questionnaire [SySQ]), which assesses the difficulty in carrying out activities of daily living and the intensity and frequency of the symptoms with the greatest functional impact in SSc. This instrument was originally designed in German and has been validated in Spanish by this working group. Include 3 domains concerning activities of daily living, intensity and frequency of symptoms. Three domains in 4 categories: 1) general symptoms; 2) musculoskeletal symptoms; 3) cardiopulmonary symptoms, and 4) symptoms of the digestive tract, which are the main organs affected and represent the greatest impact on the functionality of patients with Ssc. This scale includes an ability to perform an action section (0 = no difficulty, 1 = some difficulty, 2 = some difficulty, 3 = unable to do); another section describes the intensity of the symptoms (0 = no, 1 = mild, 2 = moderate, 3 = very severe), and finally there is a section on the frequency of the symptoms (0 = no, 1 = sometimes, 2 = often, 3 = always). The final score of the scale is calculated by averaging the maximum value obtained in each domain (block of questions) divided by 3 (given that there are 3 domains), and that value goes from 0 (normal functionality) to 3 (minimal functionality). The questionnaire formats will be provided by the pulmonary function laboratory staff to the study participants.
Forced spirometry. Spirometry is the main test of respiratory function, it evaluates respiratory mechanics and is the standard for diagnosing bronchial obstruction. The test was performed in accordance with ATS/ERS 2005 standards. Once the patient is prepared for the test, the patient is instructed about the procedure. It is explained to him that he will be sitting (preferably in a fixed chair with arm support), with his trunk upright and his head slightly elevated; He is instructed to place a mouthpiece and a nose clip in his mouth and to perform a maximum inhalation and then an exhalation with an explosive and sustained onset. The maneuver will be carried out in a closed circuit. The patient will be asked to maintain forced expiration for at least 6 seconds until reaching a plateau of at least 1 second. The available equipment is the brand and model Jaeger Sentry Suite Ver. 2.13, IOS, Germany.
Carbon monoxide diffusing capacity (DLCO) This test is necessary to evaluate gas transfer, it is necessary to complement the diagnosis and rule out interstitial damage in patients who present restriction of extrapulmonary origin. The test will be performed according to ATS/ERS 2017 standards. The patient will be seated (fixed chair with arm support), with the trunk upright and the head slightly elevated. You will be fitted with a nose clip and asked to breathe into the equipment through a sterile antibacterial mouthpiece. At the beginning, breaths were performed in tidal volume and later, based on residual functional capacity, a maximum expiration was made, until reaching a plateau of 1 second and reaching residual volume. When the residual volume was reached, the valves were activated. The patient was encouraged to perform maximum and rapid inspiration (less than 3 seconds), which reached more than 90% of his vital capacity. He must maintain an apnea for 10 seconds, taking care that there are no leaks or valsalva maneuver. The patient was instructed to make a maximum expiration, but slowly and relaxed, lasting longer than 4 seconds. The time between maneuvers was at least 4 minutes. A minimum of two efforts were completed with acceptability criteria in accordance with ATS/ERS 2017. The available equipment is the brand and model Jaeger Sentry Suite Ver. 2.13, Germany. Exercise test.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 12 Weeks
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients whit Systemic Sclerosis asociated Interstitial Lung Disease | – | Procedure: Pulmonary Rehabilitation ProgramConsecutive patients who attend the Rheumatology and Internal Medicine services with a confirmed diagnosis of Systemic Sclerosis associated Interstitial Lung disease, from the Medical Center, La Raza IMSS. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who come to the Rheumatology and Internal Medicine services with a confirmed diagnosis of Interstitial Lung Disease associated Systemic Sclerosis from the National Medical Center La Raza IMSS
Key inclusion criteria (3 listed)
- Confirmed diagnosis of SSc, determined by the treating rheumatology service either from the Rheumatology and/or Internal Medicine Service of the Specialty Hospital of the National Medical Center La Raza IMSS , based on the ACR/EULAR 2013 criteria for SSc.
- Time of evolution of the disease indistinct. You can be treated with any of the drugs in the spectrum of autoimmune disease treatment (immunosuppressants, steroids, biologics, etc.).
- Diagnosis of Interstitial Lung Disease associated with SSc, confirmed by HRCT and FVC < 80% or TLC < 80% or DLCO < 80%.
Key exclusion criteria (10 listed)
- Pregnant
- Chest, abdominal pain, oral or facial pain that prevents using the mouthpiece or forced expiration.
- Stress incontinence, dementia or confusion.
- Who have contraindications for performing physical effort.
- Oxygen dependence that does not allow its withdrawal for more than 10 minutes.
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 |
|---|---|---|
| Pulmonary Rehabilitation ProgramConsecutive patients who attend with a confirmed diagnosis of Systemic Sclerosis associated Interstitial Lung disease, at the Speciality Hospital from the Medical Center La Raza IMSS. The anxiety and depression questionnaire will be applied to them. Goldberg, as well as the SF-36 questionnaire to evaluate quality of life and the SySQ questionnaire to evaluate functionality, to include these data in the analysis, these questionnaires are validated in our population and have been widely used. All participants (T0) will undergo Forced Spirometry, Carbon Monoxide Diffusion Capacity and Cardiopulmonary Exercise Test. Then they will enter a supervised pulmonary rehabilitation program that consists of 36 sessions, which is equivalent to 12 weeks. At the end of this period (T1), again the respiratory function tests (spirometry, DLCO and Cardiopulmonary Exercise Test) as well as the Goldberg, SF-36 and SySq questionnaires. | Procedure or surgery | Patients whit Systemic Sclerosis asociated Interstitial Lung Disease |
Primary outcome
Oxygen consumption peak
Time frame: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks), estimated by cardiopulmonary exercise test
Change in oxygen consumption of at least 1.15 ml/kg/min relative to the measurement before receiving the supervised pulmonary rehabilitation program, measured in ml/min.
Quality of life health related
Time frame: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Change in the score obtained in the SF36 quality of life questionnaire of at least 20% in relation to the baseline score obtained before receiving the 12-week supervised pulmonary rehabilitation program. Where 0 is the worst quality of life and 100 is the best quality of life, scores below 50 are considered poor quality of life.
Functionality
Time frame: t will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)
Change of 1 category in the score of the functionality scale for systemic sclerosis SySQ, in relation to the score obtained before entering the 12-week supervised pulmonary rehabilitation program. This scale includes an ability to perform an action section (0 = no difficulty, 1 = some difficulty, 2 = some difficulty, 3 = unable to do); another section describes the intensity of the symptoms (0 = no, 1 = mild, 2 = moderate, 3 = very severe), and finally there is a section on the frequency of the symptoms (0 = no, 1 = sometimes, 2 = often, 3 = always). The final score of the scale is calculated by averaging the maximum value obtained in each domain (block of questions) divided by 3 (given that there are 3 domains), and that value goes from 0 (normal functionality) to 3 (minimal functionality)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2024.
- Results publication: PubMed 24092682van den Hoogen F, Khanna D, Fransen J, Johnson SR, Baron M, Tyndall A, Matucci-Cerinic M, Naden RP, Medsger TA Jr, Carreira PE, Riemekasten G, Clements PJ, Denton CP, Distler O, Allanore Y, Furst DE, Gabrielli A, Mayes MD, van Laar JM, Seibold JR, Czirjak L, Steen VD, Inanc M, Kowal-Bielecka O, Muller-Ladner U, Valentini G, Veale DJ, Vonk MC, Walker UA, Chung L, Collier DH, Ellen Csuka M, Fessler BJ, Guiducci S, Herrick A, Hsu VM, Jimenez S, Kahaleh B, Merkel PA, Sierakowski S, Silver RM, Simms RW, Varga J, Pope JE. 2013 classification criteria for systemic sclerosis: an American college of rheumatology/European league against rheumatism collaborative initiative. Ann Rheum Dis. 2013 Nov;72(11):1747-55. doi: 10.1136/annrheumdis-2013-204424.
- Results publication: PubMed 22213733Steele R, Hudson M, Lo E, Baron M; Canadian Scleroderma Research Group. Clinical decision rule to predict the presence of interstitial lung disease in systemic sclerosis. Arthritis Care Res (Hoboken). 2012 Apr;64(4):519-24. doi: 10.1002/acr.21583.
- Results publication: PubMed 24591477Nihtyanova SI, Schreiber BE, Ong VH, Rosenberg D, Moinzadeh P, Coghlan JG, Wells AU, Denton CP. Prediction of pulmonary complications and long-term survival in systemic sclerosis. Arthritis Rheumatol. 2014 Jun;66(6):1625-35. doi: 10.1002/art.38390.
- Results publication: PubMed 28413064Denton CP, Khanna D. Systemic sclerosis. Lancet. 2017 Oct 7;390(10103):1685-1699. doi: 10.1016/S0140-6736(17)30933-9. Epub 2017 Apr 13.
- Results publication: PubMed 26316389Suliman YA, Dobrota R, Huscher D, Nguyen-Kim TD, Maurer B, Jordan S, Speich R, Frauenfelder T, Distler O. Brief Report: Pulmonary Function Tests: High Rate of False-Negative Results in the Early Detection and Screening of Scleroderma-Related Interstitial Lung Disease. Arthritis Rheumatol. 2015 Dec;67(12):3256-61. doi: 10.1002/art.39405.
- Results publication: PubMed 20551155Tyndall AJ, Bannert B, Vonk M, Airo P, Cozzi F, Carreira PE, Bancel DF, Allanore Y, Muller-Ladner U, Distler O, Iannone F, Pellerito R, Pileckyte M, Miniati I, Ananieva L, Gurman AB, Damjanov N, Mueller A, Valentini G, Riemekasten G, Tikly M, Hummers L, Henriques MJ, Caramaschi P, Scheja A, Rozman B, Ton E, Kumanovics G, Coleiro B, Feierl E, Szucs G, Von Muhlen CA, Riccieri V, Novak S, Chizzolini C, Kotulska A, Denton C, Coelho PC, Kotter I, Simsek I, de la Pena Lefebvre PG, Hachulla E, Seibold JR, Rednic S, Stork J, Morovic-Vergles J, Walker UA. Causes and risk factors for death in systemic sclerosis: a study from the EULAR Scleroderma Trials and Research (EUSTAR) database. Ann Rheum Dis. 2010 Oct;69(10):1809-15. doi: 10.1136/ard.2009.114264. Epub 2010 Jun 15.
- Results publication: PubMed 27941129Kowal-Bielecka O, Fransen J, Avouac J, Becker M, Kulak A, Allanore Y, Distler O, Clements P, Cutolo M, Czirjak L, Damjanov N, Del Galdo F, Denton CP, Distler JHW, Foeldvari I, Figelstone K, Frerix M, Furst DE, Guiducci S, Hunzelmann N, Khanna D, Matucci-Cerinic M, Herrick AL, van den Hoogen F, van Laar JM, Riemekasten G, Silver R, Smith V, Sulli A, Tarner I, Tyndall A, Welling J, Wigley F, Valentini G, Walker UA, Zulian F, Muller-Ladner U; EUSTAR Coauthors. Update of EULAR recommendations for the treatment of systemic sclerosis. Ann Rheum Dis. 2017 Aug;76(8):1327-1339. doi: 10.1136/annrheumdis-2016-209909. Epub 2016 Nov 9.
- Results publication: PubMed 25832447Willems LM, Vriezekolk JE, Schouffoer AA, Poole JL, Stamm TA, Bostrom C, Kwakkenbos L, Vliet Vlieland TP, van den Ende CH. Effectiveness of Nonpharmacologic Interventions in Systemic Sclerosis: A Systematic Review. Arthritis Care Res (Hoboken). 2015 Oct;67(10):1426-39. doi: 10.1002/acr.22595.
- Results publication: PubMed 20551097Avouac J, Walker U, Tyndall A, Kahan A, Matucci-Cerinic M, Allanore Y; EUSTAR; Miniati I, Muller A, Iannone F, Distler O, Becvar R, Sierakowsky S, Kowal-Bielecka O, Coelho P, Cabane J, Cutolo M, Shoenfeld Y, Valentini G, Rovensky J, Riemekasten G, Vlachoyiannopoulos P, Caporali R, Jiri S, Inanc M, Zimmermann Gorska I, Carreira P, Novak S, Czirjak L, Oliveira Ramos F, Jendro M, Chizzolini C, Kucharz EJ, Richter J, Cozzi F, Rozman B, Mallia CM, Gabrielli A, Farge D, Kiener HP, Schoffel D, Airo P, Wollheim F, Martinovic D, Trotta F, Jablonska S, Reich K, Bombardieri S, Siakka P, Pellerito R, Bambara LM, Morovic-Vergles J, Denton C, Hinrichs R, Van den Hoogen F, Damjanov N, Kotter I, Ortiz V, Heitmann S, Krasowska D, Seidel M, Hasler P, Van Laar JM, Kaltwasser JP, Foeldvari I, Juan Mas A, Bajocchi G, Wislowska M, Pereira Da Silva JA, Jacobsen S, Worm M, Graniger W, Kuhn A, Stankovic A, Cossutta R, Majdan M, Damjanovska Rajcevska L, Tikly M, Nasonov EL, Steinbrink K, Herrick A, Muller-Ladner U, Dinc A, Scorza R, Sondergaard K, Indiveri F, Nielsen H, Szekanecz Z, Silver RM, Antivalle M, Espinosa IB, Garcia de la Pena Lefebvre P, Midtvedt O, Launay D, Valesini F, Tuvik P, Ionescu RM, Del Papa N, Pinto S, Wigley F, Mihai C, Sinziana Capranu M, Sunderkotter C, Jun JB, Alhasani S, Distler JH, Ton E, Soukup T, Seibold J, Zeni S, Nash P, Mouthon L, De Keyser F, Duruoz MT, Cantatore FP, Strauss G, von Mulhen CA, Pozzi MR, Eyerich K, Szechinski J, Keiserman M, Houssiau FA, Roman-Ivorra JA, Krummel-Lorenz B, Aringer M, Westhovens R, Bellisai F, Mayer M, Stoeckl F, Uprus M, Volpe A, Buslau M, Yavuz S, Granel B, Valderilio Feijo A, Del Galdo F, Popa S, Zenone T, Ricardo Machado X, Pileckyte M, Stebbings S, Mathieu A, Tulli A, Tourinho T, Souza R, Acayaba de Toledo R, Stamp L, Solanki K, Veale D, Francisco Marques Neto J, Bagnato GF, Loyo E, Toloza S, Li M, Ahmed Abdel Atty Mohamed W, Cobankara V, Olas J, Salsano F, Oksel F, Tanaseanu CM, Foti R, Ancuta C, Vonk M, Caramashi P, Beretta L, Balbir A, Chiala A, Pasalic Simic K, Ghio M, Stamenkovic B, Rednic S, Host N, Pellerito R, Hachulla E, Furst DE. Characteristics of joint involvement and relationships with systemic inflammation in systemic sclerosis: results from the EULAR Scleroderma Trial and Research Group (EUSTAR) database. J Rheumatol. 2010 Jul;37(7):1488-501. doi: 10.3899/jrheum.091165. Epub 2010 Jun 15.
- Results publication: PubMed 623695Clements PJ, Furst DE, Campion DS, Bohan A, Harris R, Levy J, Paulus HE. Muscle disease in progressive systemic sclerosis: diagnostic and therapeutic considerations. Arthritis Rheum. 1978 Jan-Feb;21(1):62-71. doi: 10.1002/art.1780210111.
- Results publication: PubMed 25789555Lima TR, Guimaraes FS, Carvalho MN, Sousa TL, Menezes SL, Lopes AJ. Lower limb muscle strength is associated with functional performance and quality of life in patients with systemic sclerosis. Braz J Phys Ther. 2015 Mar-Apr;19(2):129-36. doi: 10.1590/bjpt-rbf.2014.0084. Epub 2015 Mar 13.
- Results publication: PubMed 6673113Blom-Bulow B, Jonson B, Bauer K. Factors limiting exercise performance in progressive systemic sclerosis. Semin Arthritis Rheum. 1983 Nov;13(2):174-81. doi: 10.1016/0049-0172(83)90004-5.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Sclerosis Associated Interstitial Lung Disease, run by Coordinación de Investigación en Salud, Mexico 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 3 inclusion and 10 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: status not confirmed, as of the sponsor's last update on 2 Feb 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oxygen consumption peak (time frame: It will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks), estimated by cardiopulmonary exercise test). The study lists 3 primary outcomes in all. 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 NCT06105073, which also lists 21 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 2 Feb 2024.