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OpenTrials
Completed

NCT Number: NCT04184193

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

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.

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Key information

Conditions

Lymphangioleiomyomatosis Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders LAM Lymphangiomyoma Lymphatic Diseases Lymphoproliferative Disorders Neoplasm, Lymphatic Tissue Neoplasms Neoplasms by Histologic Type Neoplasms, Connective and Soft Tissue Perivascular Epithelioid Cell Neoplasms Pulmonary Rehabilitation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Schoen Klinik Berchtesgadener Land

Schönau am Königssee, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Pulmonary Rehabilitation

Other

Patients will perform a comprehensive, inpatient pulmonary rehabilitation program for 4 weeks duration

Primary outcomes

  1. Change from baseline 6 Minute walk distance at week 4

    Time frame: baseline and week 4

    the walked distance in meter will be the Primary outcome of the 6 Minute walk test

  2. Change from baseline Quality of life at week 4

    Time frame: baseline and 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

Secondary outcomes

  1. Change from baseline lung function at week 4

    Time frame: baseline and week 4

    forced expiratory volume in 1 second and inspiratory vital capacity will be provided in Liter and percent predicted

Sponsors and collaborators

Lead sponsor

Schön Klinik Berchtesgadener Land

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Dec 3, 2019
Registry last updated
Jan 21, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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