Clinical trial NCT00759538: Effect of Early Pulmonary Rehabilitation After Lung Transplantation
Official title: Effect of Early Pulmonary Rehabilitation After Lung Transplantation in Patients With a Prolonged Length of Stay on the Waiting List and Hospitalization After Transplantation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lung Transplantation
Keywords: Lung Transplantation
Pulmonary Rehabilitation
Exercise tolerance
Quality of Life
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
Collaborators: name: Klinik Fallingbostel Rehabilitation Center
First posted: 2008-09-25
Enrollment: 120
Sex: ALL
Minimum age (years): 17
Maximum age (years): 67
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: lung transplant patients performing a three week lasting rehabilitation program

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* Recipients of single or double lung transplants
* Recipients of combined (heart and lung or heart an liver) transplants

Primary outcomes:
measure: Exercise capacity at the end of an early short-term after lung transplantation
timeFrame: 3 years
Secondary outcomes:
measure: Lung function
timeFrame: 3 years
measure: Body composition
timeFrame: 3 years
measure: Activities of daily living
timeFrame: 3 years
measure: Health Status (SF-36)
timeFrame: 3 years
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School, Dpt. of Respiratory Medicine
Study officials:
affiliation: Hannover Medical School, Dpt. of Respiratory Medicine
name: Martin Dierich, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.