Effect of Early Pulmonary Rehabilitation After Lung Transplantation

Lung Transplantation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00759538
• Other study ID #: MHH-2008-4
• Status: Completed
• Phase: N/A
• First received: September 24, 2008
• Last updated: July 30, 2012
• Start date: July 2007
• Est. completion date: December 2008

Study information

• Verified date: July 2012
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: December 2008
• Est. primary completion date: July 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 17 Years to 67 Years

Eligibility

Inclusion Criteria:

• Recipients of single or double lung transplants

• Recipients of combined (heart and lung or heart an liver) transplants

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Lung Transplantation

Locations

Country	Name	City	State
Germany	Hannover Medical School, Dpt. of Respiratory Medicine	Hannover

Sponsors (2)

Lead Sponsor	Collaborator
Hannover Medical School	Klinik Fallingbostel Rehabilitation Center

Country where clinical trial is conducted

Germany, 

References & Publications (4)

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. — View 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. German. — View Citation

Schwaiblmair M, Reichenspurner H, Müller C, Briegel J, Fürst 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. — View Citation

Tegtbur U, Sievers C, Busse MW, Pethig K, Warnecke G, Kugler C, Gützlaff E, Künsebeck HW, Strüber M, Haverich A, Niedermeyer J. [Quality of life and exercise capacity in lung transplant recipients]. Pneumologie. 2004 Feb;58(2):72-8. German. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Exercise capacity at the end of an early short-term after lung transplantation		3 years	No
Secondary	Lung function		3 years	No
Secondary	Body composition		3 years	No
Secondary	Activities of daily living		3 years	No
Secondary	Health Status (SF-36)		3 years	No