Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM)

Pulmonary Rehabilitation Clinical Trial

Official title:

Benefits of Pulmonary Rehabilitation in Patients With Severe Lymphangioleiomyomatosis (LAM) - a Retrospective Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184193
• Other study ID #: LAM Trial
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: December 23, 2019

Study information

• Verified date: January 2020
• Source: Schön Klinik Berchtesgadener Land
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Data from patients with the orphan disease of lymphangioleiomyomatosis (LAM) which performed a pulmonary Rehabilitation program will be analyzed retrospectively. Data will be taken from the internal data base of the reference Center (Schoen Klinik Berchtesgadener Land, Schoenau, Germany) where These data were collected during clinical routine. Data will be included from the year 2000 until now. A retrospectively matched COPD cohort will be included for comparison.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: December 23, 2019
• Est. primary completion date: December 23, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• confirmed diagnosis of Lymphangioleiomyomatosis

• performed a pulmonary Rehabilitation program at the reference center

Exclusion Criteria:

• missing data

• repeated stay for pulmonary Rehabilitation at the reference center

Related Conditions & MeSH terms

• LAM
• Lymphangioleiomyomatosis
• Pulmonary Rehabilitation

Intervention

Other:
• Pulmonary Rehabilitation
Patients will perform a comprehensive, inpatient pulmonary rehabilitation program for 4 weeks duration

Locations

Country	Name	City	State
Germany	Schoen Klinik Berchtesgadener Land	Schönau Am Königssee

Sponsors (1)

Lead Sponsor	Collaborator
Schön Klinik Berchtesgadener Land

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline 6 Minute walk distance at week 4	the walked distance in meter will be the Primary outcome of the 6 Minute walk test	baseline and week 4
Primary	Change from baseline Quality of life at week 4	the physical and mental health component summary score from the Short Form 36 Health Questionnaire will be recorded. Score range from 0 to 100 with lower scores indicating worse impairment	baseline and week 4
Secondary	Change from baseline lung function at week 4	forced expiratory volume in 1 second and inspiratory vital capacity will be provided in Liter and percent predicted	baseline and week 4