Effect of Early Pulmonary Rehabilitation After Lung Transplantation
30. juli 2012 opdateret af: Martin G Dierich, MD, Hannover Medical School
Effect of Early Pulmonary Rehabilitation After Lung Transplantation in Patients With a Prolonged Length of Stay on the Waiting List and Hospitalization After Transplantation
The purpose of this observation study is to evaluate the effects of an early, 3 week lasting rehabilitation program, that starts roundabout 4 weeks after lung or combined lung transplantation, on physical activity, functional and physical condition (6-min-walk, FEV1, ADL-score) and quality of life (SF36) in lung transplant recipients with a different length of stay on the waiting list and a different duration of hospitalization in the transplantation centre after transplantation.
Studieoversigt
Status
Afsluttet
Betingelser
Detaljeret beskrivelse
To which extend a prolonged duration from listing for lung transplantation until a successful transplantation or a long length of hospitalization may influence the success of a pulmonary rehabilitation, that starts after discharge from the transplantation centre, is still unknown.
Long waiting periods before transplantation and surgical, infectious or immunological complications after transplantation influence the physical condition and the quality of life of the organ recipient.
A poor physical condition before transplantation results in an unfavourable outcome in the first 12 months after transplantation.
At present it is unclear, whether a structured pulmonary rehabilitation may overwhelm differences between patients with a prolonged course roundabout the transplantation compared or not. At present it is not clear whether it is necessary for lung transplant recipients to participate in a rehabilitation program including structured exercise training.
The aim of this observational study is to assess the effect of a short-term pulmonary rehabilitation, that starts immediately after discharge from the transplantation centre on patients with a prolonged waiting period or an extended postoperative hospitalization.
- Hypothesis: a structured pulmonary rehabilitation early after transplantation may overwhelm poor physical and functional conditions after a prolonged period on the transplant waiting listor a prolonged hospitalization after transplantation resulting in a significant improvement in all transplanted patients
- Antithesis: a prolonged period on the waiting list before transplantation or a prolonged hospitalization after transplantation can not be influenced significantly by an early transplant rehabilitation resulting in a persistent lack of functional status and quality of life compared with a short waiting period or a normal duration of hospitalization after transplantation.
- Outcomes: functional status (6-min. walk, exercise capacity, FEV1, ADL), and quality of life (SF36) will be assessed at the beginning and on discharge from the rehabilitation centre.
Undersøgelsestype
Observationel
Tilmelding (Faktiske)
120
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
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Hannover, Tyskland
- Hannover Medical School, Dpt. of Respiratory Medicine
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
17 år til 67 år (Barn, Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Køn, der er berettiget til at studere
Alle
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
lung transplant patients performing a three week lasting rehabilitation program
Beskrivelse
Inclusion Criteria:
- Recipients of single or double lung transplants
- Recipients of combined (heart and lung or heart an liver) transplants
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
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1
lung transplant patients performing a three week lasting rehabilitation program
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Exercise capacity at the end of an early short-term after lung transplantation
Tidsramme: 3 years
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3 years
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Lung function
Tidsramme: 3 years
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3 years
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Body composition
Tidsramme: 3 years
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3 years
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Activities of daily living
Tidsramme: 3 years
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3 years
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Health Status (SF-36)
Tidsramme: 3 years
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3 years
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Martin Dierich, MD, Hannover Medical School, Dpt. of Respiratory Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- Tegtbur U, Sievers C, Busse MW, Pethig K, Warnecke G, Kugler C, Gutzlaff E, Kunsebeck HW, Struber M, Haverich A, Niedermeyer J. [Quality of life and exercise capacity in lung transplant recipients]. Pneumologie. 2004 Feb;58(2):72-8. doi: 10.1055/s-2003-812526. German.
- Schwaiblmair M, Reichenspurner H, Muller C, Briegel J, Furst H, Groh J, Reichart B, Vogelmeier C. Cardiopulmonary exercise testing before and after lung and heart-lung transplantation. Am J Respir Crit Care Med. 1999 Apr;159(4 Pt 1):1277-83. doi: 10.1164/ajrccm.159.4.9805113.
- Schultz K, Bergmann KC, Kenn K, Petro W, Heitmann RH, Fischer R, Lang SM. [Effectiveness of inpatient pulmonary rehabilitation (AHB). Results of a multicenter prospective observation study]. Dtsch Med Wochenschr. 2006 Aug 18;131(33):1793-8. doi: 10.1055/s-2006-949155. German.
- Maury G, Langer D, Verleden G, Dupont L, Gosselink R, Decramer M, Troosters T. Skeletal muscle force and functional exercise tolerance before and after lung transplantation: a cohort study. Am J Transplant. 2008 Jun;8(6):1275-81. doi: 10.1111/j.1600-6143.2008.02209.x. Epub 2008 Apr 29.
- Dierich M, Tecklenburg A, Fuehner T, Tegtbur U, Welte T, Haverich A, Warnecke G, Gottlieb J. The influence of clinical course after lung transplantation on rehabilitation success. Transpl Int. 2013 Mar;26(3):322-30. doi: 10.1111/tri.12048. Epub 2013 Jan 7.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. juli 2007
Primær færdiggørelse (Faktiske)
1. juli 2007
Studieafslutning (Faktiske)
1. december 2008
Datoer for studieregistrering
Først indsendt
24. september 2008
Først indsendt, der opfyldte QC-kriterier
24. september 2008
Først opslået (Skøn)
25. september 2008
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
31. juli 2012
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
30. juli 2012
Sidst verificeret
1. juli 2012
Mere information
Begreber relateret til denne undersøgelse
Andre undersøgelses-id-numre
- MHH-2008-4
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .
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