Trial document




drksid header

  DRKS00000560

Trial Description

start of 1:1-Block title

Title

Prospective observational study - rehabilitation in patients with sarcoidosis

end of 1:1-Block title
start of 1:1-Block acronym

Trial Acronym

ProKaSaRe

end of 1:1-Block acronym
start of 1:1-Block url

URL of the Trial

[---]*

end of 1:1-Block url
start of 1:1-Block public summary

Brief Summary in Lay Language

In Germany no current data are available concerning the indication, methodology and results of rehabilitation in chronic sarcoidosis. We intend to collect data in a multicenter conducted, prospective study which could answer the following questions: Which are the characteristics of patients treated in inpatient pulmonary rehabilitation? Which are the short- and the long-term results of the specific rehabilitation in view of symptoms, exercise capacity (6 minute walk distance) and quality of life (QL)? Will the HRQoL change after dismissal? How will the HRQoL develope in the 12 month following the rehabilitation? Defined specific medical measurements and tests are realized at the beginning and the end of the rehabilitation and a questionnaire concerning symptoms and QL is administrated to all sarcoidosis patients which present themselves at the 6 participating pulmonary rehabilitation clinics in Germany & from which we have obtained written consent. The previous introduced and used questionnaire will be distributed to the participants also 3, 6 and 12 months after dismissal.

end of 1:1-Block public summary
start of 1:1-Block scientific synopsis

Brief Summary in Scientific Language

In Germany no current data are available concerning the indication, methodology and results of rehabilitation in chronic sarcoidosis. We intend to collect data in a multicenter conducted, prospective study which could answer the following questions: Which are the characteristics of patients treated in inpatient pulmonary rehabilitation? Which are the short- and the long-term results of the specific rehabilitation in view of symptoms, exercise capacity (6 minute walk distance) and quality of life (QL)? Will the QL change after dismissal? How will the QL develop in the 12 month following the rehabilitation? Defined specific medical measurements and tests are realized at the beginning and the end of the rehabilitation and a questionnaire concerning symptoms and QL is administrated to all sarcoidosis patients which present themselves at the 6 participating pulmonary rehabilitation clinics in Germany & from which we have obtained written consent. The previous introduced and used questionnaire will be distributed to the participants also 3, 6 and 12 months after dismissal.

Inclusion criteria : (1) All patients with a first diagnosis of chronic sarcoidosis wich presents for a rehabilitation at one of the participating centres (2) written consent Exclusion criteria – (1) no written consent could bee obtained, (2) poor language skills
Checkpoints for the different tests and measurements and application of the Questionnaire: T0 = beginning of the rehabilitation T1 = at the end of rehabilitation T2 = 3 months after the end of rehabilitation T3 = 6 months after the end of rehabilitation T4 = 12 months after the end of rehabilitation to be collected data
Specific medical measurements and tests realized course of the study & applied questionnaire:
1 . Master data (T0) (age, sex)
2 Diagnoses - such as the diagnosis was backed up?
3. Organ involvement and general symptoms
4. Lung function tests: VC, RV max, TLC, FEV1, SRAW, Tiffeneau [each before / after bronchospasmolysis], P 0.1 and PI. (T0, T1)
5. Gas exchange: resting and exercise-BGA (25/50 Watt), TLCO SB, TLCO / VA, (T0, T1)
6. 6-MWD (T0, T1)
7. MRC (T0, T1, T2, T3, T4)
8. Laboratory parameters: ACE, CRP (T0, T1)
9. Quality of life: SGRQ (T0, T1, T2, T3, T4) and SF 36 (T0, T1, T2, T3, T4)
10. Psychological distress: HADS, Fatigue: FAS (T0, T1, T2, T3, T4)
11 Sozialmed. Status (T0, T1)
12 Social Medical patient questionnaire (T2, T3, T4)
13 Evaluation of rehabilitation from the perspective of the patient (T1)
14 The rehab. therapy components? - Importance of Patient-term (T1)

end of 1:1-Block scientific synopsis
start of 1:1-Block organizational data

Organizational Data

  •   DRKS00000560
  •   2011/01/18
  •   [---]*
  •   yes
  •   Approved
  •   877, Ethikkommission der Medizinischen Hochschule Hannover
end of 1:1-Block organizational data
start of 1:n-Block secondary IDs

Secondary IDs

  • [---]*
end of 1:n-Block secondary IDs
start of 1:N-Block indications

Health Condition or Problem studied

  •   D86 -  Sarcoidosis
end of 1:N-Block indications
start of 1:N-Block interventions

Interventions/Observational Groups

  •   For the study, there is no special intervention - except the normal pulmonary rehabilitation. The patients have to undergo the routine assessments of pulmonary rehab and to answer merely several questionnaires. (at the beginning and at the end of the rehab, as well as after 3, 6, and 12 months).
end of 1:N-Block interventions
start of 1:1-Block design

Characteristics

  •   Non-interventional
  •   Observational study
  •   Single arm study
  •   Open (masking not used)
  •   [---]*
  •   Uncontrolled/Single arm
  •   Health care system
  •   Single (group)
  •   N/A
  •   [---]*
end of 1:1-Block design
start of 1:1-Block primary endpoint

Primary Outcome

Health related quality of life (SGRQ)* and physical performance (6-MWD) ** after pulmonary rehabilitation (* at the begiinning and end of rehab and after 3,6 and 12 months. ** at the begiinning and end of rehab )

end of 1:1-Block primary endpoint
start of 1:1-Block secondary endpoint

Secondary Outcome

fatique, symptoms (at the begiinning and end of rehab and after 3,6 and 12 months)

end of 1:1-Block secondary endpoint
start of 1:n-Block recruitment countries

Countries of Recruitment

  •   Germany
end of 1:n-Block recruitment countries
start of 1:n-Block recruitment locations

Locations of Recruitment

  • [---]*
end of 1:n-Block recruitment locations
start of 1:1-Block recruitment

Recruitment

  •   Actual
  •   2011/01/17
  •   200
  •   Multicenter trial
  •   National
end of 1:1-Block recruitment
start of 1:1-Block inclusion criteria

Inclusion Criteria

  •   Both, male and female
  •   18   Years
  •   80   Years
end of 1:1-Block inclusion criteria
start of 1:1-Block inclusion criteria add

Additional Inclusion Criteria

(1) In-clinic-patient with sarkoidosis
(2) informed consent
(3) inadequate knowledge of the German language

end of 1:1-Block inclusion criteria add
start of 1:1-Block exclusion criteria

Exclusion Criteria

(1) Missing written participation explanation, (2) lacking linguistic proficiency

end of 1:1-Block exclusion criteria
start of 1:n-Block addresses

Addresses

  • start of 1:1-Block address primary-sponsor
    • Klinik Bad Reichenhall
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8 -11
    • 83435  Bad Reichenhall
    • Germany
    end of 1:1-Block address primary-sponsor
    start of 1:1-Block address contact primary-sponsor
    end of 1:1-Block address contact primary-sponsor
  • start of 1:1-Block address scientific-contact
    • Klinik Bad Reichenhall der DRV Bayern Süd
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435   Bad Reichenhall
    • Germany
    end of 1:1-Block address scientific-contact
    start of 1:1-Block address contact scientific-contact
    end of 1:1-Block address contact scientific-contact
  • start of 1:1-Block address public-contact
    • Klinik Bad Reichenhall der DRV Bayern Süd
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435   Bad Reichenhall
    • Germany
    end of 1:1-Block address public-contact
    start of 1:1-Block address contact public-contact
    end of 1:1-Block address contact public-contact
end of 1:n-Block addresses
start of 1:n-Block material support

Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Klinik Bad Reichenhall der DRV Bayern Süd
    • Mr.  Dr. med.  Konrad  Schultz 
    • Salzburger Str. 8-11
    • 83435   Bad Reichenhall
    • Germany
    end of 1:1-Block address materialSupport
    start of 1:1-Block address contact materialSupport
    end of 1:1-Block address contact materialSupport
end of 1:n-Block material support
start of 1:1-Block state

Status

  •   Recruiting complete, follow-up complete
  •   2013/01/30
end of 1:1-Block state
start of 1:n-Block publications

Trial Publications, Results and other Documents

  •   Lingner H, Großhennig A, Flunkert K, Buhr-Schinner H, Heitmann R, Tönnesmann U, van der Meyden J, Schultz K. ProKaSaRe Study Protocol: A Prospective Multicenter Study of Pulmonary Rehabilitation of Patients With Sarcoidosis. JMIR Res Protoc. 2015 Dec 4;4(4):e134. doi: 10.2196/resprot.4948.
  •   Lingner H, Buhr-Schinner H, Hummel S, van der Meyden J, Grosshennig A, Nowik D, Schultz K. Short-Term Effects of a Multimodal 3-Week Inpatient Pulmonary Rehabilitation Programme for Patients with Sarcoidosis: The ProKaSaRe Study. Respiration. 2018;95(5):343-353. doi: 10.1159/000486964. Epub 2018 Feb 27.
end of 1:n-Block publications
* This entry means the parameter is not applicable or has not been set.