"Pulmonary Rehabilitation Program in Patients With Interstitial Lung Disease Associated With Systemic Sclerosis"

NCT06105073 | Unknown DMC

• 1 other identifier: CNCI-R-2021-785-064
• Study Type: observational
• Target: 67
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Systemic Sclerosis Associated Interstitial Lung Disease

Keywords

Systemic sclerosis; Interstitial lung disease; Pulmonary rehabilitation program; Quality of life; Oxygen consumption; Functionality

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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)

  t will be measured before the pulmonary rehabilitation therapy and at the end (12 weeks)

Study Arms (1)

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.

Procedure: Pulmonary Rehabilitation Program

Interventions

Pulmonary Rehabilitation Program PROCEDURE

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.

Patients whit Systemic Sclerosis asociated Interstitial Lung Disease

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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

You may qualify if:

• 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%.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Coordinación de Investigación en Salud, Mexico: lead

Study Sites (1)

Centro Medico Nacional La Raza

Mexico City, 02990, Mexico

RECRUITING

Related Publications (21)

• 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.

  PMID: 24092682 RESULT

• Steele 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.

  PMID: 22213733 RESULT

• Nihtyanova 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.

  PMID: 24591477 RESULT

• Denton 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.

  PMID: 28413064 RESULT

• Suliman 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.

  PMID: 26316389 RESULT

• Tyndall 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.

  PMID: 20551155 RESULT

• Kowal-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.

  PMID: 27941129 RESULT

• Willems 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.

  PMID: 25832447 RESULT

• Avouac 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.

  PMID: 20551097 RESULT

• Clements 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.

  PMID: 623695 RESULT

• Lima 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.

  PMID: 25789555 RESULT

• Blom-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.

  PMID: 6673113 RESULT

• Cuomo 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.

  PMID: 20476863 RESULT

• de 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.

  PMID: 18092268 RESULT

• Hudson 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.

  PMID: 19644906 RESULT

• Oliveira NC, dos Santos Sabbag LM, de Sa Pinto AL, Borges CL, Lima FR. Aerobic exercise is safe and effective in systemic sclerosis. Int J Sports Med. 2009 Oct;30(10):728-32. doi: 10.1055/s-0029-1224180. Epub 2009 Jul 29.

  PMID: 19642060 RESULT

• Holland AE. Exercise limitation in interstitial lung disease - mechanisms, significance and therapeutic options. Chron Respir Dis. 2010;7(2):101-11. doi: 10.1177/1479972309354689. Epub 2010 Jan 7.

  PMID: 20056733 RESULT

• Holland A, Hill C. Physical training for interstitial lung disease. Cochrane Database Syst Rev. 2008 Oct 8;(4):CD006322. doi: 10.1002/14651858.CD006322.pub2.

  PMID: 18843713 RESULT

• Miller MR, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Crapo R, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. Standardisation of spirometry. Eur Respir J. 2005 Aug;26(2):319-38. doi: 10.1183/09031936.05.00034805. No abstract available.

  PMID: 16055882 RESULT

• Graham BL, Brusasco V, Burgos F, Cooper BG, Jensen R, Kendrick A, MacIntyre NR, Thompson BR, Wanger J. 2017 ERS/ATS standards for single-breath carbon monoxide uptake in the lung. Eur Respir J. 2017 Jan 3;49(1):1600016. doi: 10.1183/13993003.00016-2016. Print 2017 Jan.

  PMID: 28049168 RESULT

• American Thoracic Society; American College of Chest Physicians. ATS/ACCP Statement on cardiopulmonary exercise testing. Am J Respir Crit Care Med. 2003 Jan 15;167(2):211-77. doi: 10.1164/rccm.167.2.211. No abstract available.

  PMID: 12524257 RESULT

MeSH Terms

Conditions

Scleroderma, Systemic; Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases; Lung Diseases; Respiratory Tract Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Weeks
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 23, 2023
• First Posted: October 27, 2023
• Study Start: March 1, 2022
• Primary Completion: March 1, 2023
• Study Completion: March 1, 2024
• Last Updated: February 2, 2024

Record last verified: 2023-10

Data Sharing

• IPD Sharing: Will not share

Locations

ME (1)