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      ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis


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          Available data assessing the efficacy of pulmonary rehabilitation for patients with chronic sarcoidosis are scant; for Germany, there are none at all.


          To gain information about the benefit of in-house pulmonary rehabilitation for patients with chronic sarcoidosis and for the health care system, we intend to collect data in a prospective multicenter “real-life” cohort trial.


          ProKaSaRe (Prospektive Katamnesestudie Sarkoidose in der pneumologischen Rehabilitation) [Prospective Catamnesis Study of Sarcoidosis in Pulmonary Rehabilitation] will assess a multimodal 3-week inpatient pulmonary rehabilitation program for adult patients with chronic sarcoidosis over a 1-year follow-up time. Defined specific clinical measurements and tests will be performed at the beginning and the end of the rehabilitation. In addition, questionnaires concerning health-related quality of life and the patients’ symptoms will be provided to all patients. Inclusion criteria will be referral to one of the 6 participating pulmonary rehabilitation clinics in Germany for sarcoidosis and age between 18 and 80 years. Patients will only be excluded for a lack of German language skills or the inability to understand and complete the study questionnaires. To rule out seasonal influences, the recruitment will take place over a period of 1 year. In total, at least 121 patients are planned to be included. A descriptive statistical analysis of the data will be performed, including multivariate analyses. The primary outcomes are specific health-related quality of life (St George’s Respiratory Questionnaire) and exercise capacity (6-minute walk test). The secondary outcomes are several routine lung function and laboratory parameters, dyspnea scores and blood gas analysis at rest and during exercise, changes in fatigue, psychological burden, and generic health-related quality of life (36-item Short Form Health Survey).


          Funding was obtained on October 12, 2010; enrollment began on January 15, 2011 and was completed by January 14, 2012. Results are anticipated late summer 2015.


          Due to the large number of participants, we expect to obtain representative findings concerning the effectiveness of pulmonary rehabilitation for patients with sarcoidosis and to provide a dataset of assessed objective and subjective short- and long-term changes due to pulmonary rehabilitation. The results should form the basis for the planning of a randomized controlled trial.

          Trial Registration

          German Clinical Trials Register: DRKS00000560; https://drks-neu.uniklinik-freiburg.de/ drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00000560 (Archived by WebCite® at http://www.webcitation.org/6dKb5X87R)

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          Most cited references47

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          Statement on sarcoidosis. Joint Statement of the American Thoracic Society (ATS), the European Respiratory Society (ERS) and the World Association of Sarcoidosis and Other Granulomatous Disorders (WASOG) adopted by the ATS Board of Directors and by the ERS Executive Committee, February 1999.

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            Sarcoidosis is a systemic disease of unknown cause that is characterised by the formation of immune granulomas in various organs, mainly the lungs and the lymphatic system. Studies show that sarcoidosis might be the result of an exaggerated granulomatous reaction after exposure to unidentified antigens in individuals who are genetically susceptible. Several new insights have been made, particularly with regards to the diagnosis and care of some important manifestations of sarcoidosis. The indications for endobronchial ultrasound in diagnosis and for PET in the assessment of inflammatory activity are now better specified. Recognition of unexplained persistent disabling symptoms, fatigue, small-fibre neurological impairment, cognitive failure, and changes to health state and quality of life, has improved. Mortality in patients with sarcoidosis is higher than that of the general population, mainly due to pulmonary fibrosis. Predicted advances for the future are finding the cause of sarcoidosis, and the elucidation of relevant biomarkers, reliable endpoints, and new efficient treatments, particularly in patients with refractory sarcoidosis, lung fibrosis, and those with persistent disabling symptoms. Copyright © 2014 Elsevier Ltd. All rights reserved.
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              Psychometric qualities of a brief self-rated fatigue measure: The Fatigue Assessment Scale.

              The main aim of this study was to examine the dimensionality and psychometric qualities of a new 10-item fatigue measure, the Fatigue Assessment Scale (FAS). As part of a longitudinal study, the respondents, all workers with at least 20 working hours per week, completed the FAS, four related fatigue measures, a depression questionnaire, and an emotional stability scale. The FAS had a high internal consistency. The pattern of correlations and factor analysis showed good convergent and divergent validity. The FAS correlated strongly with the other fatigue scales. In a factor analysis of the five fatigue questionnaires, the FAS had the highest factor loading on a clear one-factor solution. Moreover, factor analyses revealed that fatigue, on the one hand, and depression and emotional stability, on the other hand, are separate constructs. Finally, it was shown that 8 out of the 10 FAS items were unbiased concerning gender; two had a uniform bias. The FAS represents a potentially valuable assessment instrument with promising internal consistency reliability and validity. Gender bias in the FAS does not have consequences for use of the FAS.

                Author and article information

                JMIR Res Protoc
                JMIR Res Protoc
                JMIR Research Protocols
                JMIR Publications Inc. (Toronto, Canada )
                Oct-Dec 2015
                04 December 2015
                : 4
                : 4
                : e134
                [1] 1Centre for Public Health and Healthcare Hannover Medical School HannoverGermany
                [2] 2Institute of Biostatistics Hannover Medical School HannoverGermany
                [3] 3Ostseeklinik Schönberg Holm Centre for Rehabilitation, Pneumology, Cardiology and Orthopedics Schönberg-HolmGermany
                [4] 4Centre for Rehabilitation, Pneumology and Cardiology MediClin Albert Schweitzer Klinik KönigsfeldGermany
                [5] 5Center for Rehabilitation, Pneumology and Oncology Wehrawald Clinic TodtmoosGermany
                [6] 6Bad Reichenhall Clinic Centre for Rehabilitation, Pneumology and Orthopedics Bad ReichenhallGermany
                Author notes
                Corresponding Author: Konrad Schultz konrad.schultz@ 123456klinik-bad-reichenhall.de
                Author information
                ©Heidrun Lingner, Anika Großhennig, Kathrin Flunkert, Heike Buhr-Schinner, Rolf Heitmann, Ulrich Tönnesmann, Jochen van der Meyden, Konrad Schultz. Originally published in JMIR Research Protocols (http://www.researchprotocols.org), 04.12.2015.

                This is an open-access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work, first published in JMIR Research Protocols, is properly cited. The complete bibliographic information, a link to the original publication on http://www.researchprotocols.org, as well as this copyright and license information must be included.

                : 17 July 2015
                : 5 August 2015
                : 19 August 2015
                : 20 September 2015
                Original Paper

                sarcoidosis,rehabilitation,quality of life,fatigue
                sarcoidosis, rehabilitation, quality of life, fatigue


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