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Evaluation of Exercise Capacity and Exercise Limitation in Patients With Pulmonary Langerhans Cell Histiocytosis

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ClinicalTrials.gov Identifier: NCT02665546
Recruitment Status : Completed
First Posted : January 27, 2016
Last Update Posted : March 1, 2019
Sponsor:
Information provided by (Responsible Party):
Bruno Guedes Baldi, InCor Heart Institute

Brief Summary:
Pulmonary Langerhans Histiocytosis Cells (PLCH) is characterized by infiltration of Langerhans cells and formation of loose granulomas with lymphocytic infiltrate and formation of nodular and cystic lesions on chest CT, and is often associated with smoking. Functionally, there may be obstructive and / or restrictive defect, with reduced carbon monoxide diffusing capacity. Dyspnea and lower exercise tolerance are common in PLCH, but exercise capacity in this disease is poorly understood and has not been compared to controls. Besides, the mechanisms involved in limiting exercise are poorly understood and cover multiple factors such as change in gas exchange, pulmonary hypertension (PH), dynamic hyperinflation, physical deconditioning and left heart failure. The involvement of pulmonary circulation in PLCH has unknown prevalence, but contributes to the symptoms. In the PH classification, PLCH belongs to the group 5, of multifactorial etiology. The definition of the presence and contribution of dyspnea mechanisms in different severities of PLCH is important to understanding the disease and individualization of treatment. The objective of the study is to evaluate the exercise capacity of patients with HCLP, and determinate mechanisms of dyspnea and lower exercise tolerance beyond its impact on quality of life.

Condition or disease
Langerhans Cell Histiocytosis

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Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Evaluation of Exercise Capacity and Mechanisms of Exercise Limitation in Patients With Pulmonary Langerhans Cell Histiocytosis
Actual Study Start Date : March 2016
Actual Primary Completion Date : October 2018
Actual Study Completion Date : December 2018


Group/Cohort
Case
Patients with diagnosis of LCH based on histopathological or clinical and radiological findings.
Controls
Current or ex smokers matched with cases for age, gender and smoking history.



Primary Outcome Measures :
  1. Maximal O2 uptake capacity (VO2 max) [ Time Frame: Baseline ]
    Maximal O2 uptake capacity (VO2 max) during a cardiopulmonary exercise test (mL/kg/min)


Secondary Outcome Measures :
  1. Six-minute walk distance [ Time Frame: Baseline ]
    Distance during a six-minute walk test in meters

  2. Short Form Health Survey (SF-36) [ Time Frame: Baseline ]
    SF-36 questionnaire to evaluate quality of life

  3. Diffusing capacity for carbon monoxide [ Time Frame: Baseline ]
    Diffusing capacity for carbon monoxide (mL/min/mmHg)

  4. Inspiratory capacity [ Time Frame: Baseline ]
    Serial measurement of inspiratory capacity during incremental cardiopulmonary exercise test (L)

  5. Forced expiratory volume in the first 1 second (FEV1) [ Time Frame: baseline ]
    FEV1 (Pulmonary lung function - spirometry) - L

  6. Velocity measurement of tricuspid regurgitant jet [ Time Frame: Baseline ]
    Velocity measurement of tricuspid regurgitant jet evaluated by transthoracic echocardiography (m/s)

  7. Residual volume/total lung capacity ratio [ Time Frame: baseline ]
    Residual volume/total lung capacity ratio evaluated in pulmonary lung function - plethysmography

  8. Residual volume [ Time Frame: Baseline ]
    Residual volume evaluated in pulmonary lung function - plethysmography (L)

  9. Baseline Dyspnea Index [ Time Frame: Baseline ]
    Baseline Dyspnea Index

  10. Six-minute walk test desaturation [ Time Frame: Baseline ]
    Desaturation during a six-minute walk test (%)

  11. Ejection fraction [ Time Frame: Baseline ]
    Ejection fraction evaluated by transthoracic echocardiography (%)

  12. Diameter of the cardiac chambers [ Time Frame: Baseline ]
    Diameter of the cardiac chambers evaluated by transthoracic echocardiography (cm)



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with diagnosis of pulmonary Langerhans cell histiocytosis and current or ex smokers followed at the outpatient clinic of the Pulmonary Division of the Hospital das Clinicas of the University of Sao Paulo
Criteria

Inclusion Criteria:

  • proven diagnosis of pulmonary Langerhans cell histiocytosis based on histopathological or clinical and radiological findings;

Exclusion Criteria:

  • lung transplantation
  • cognitive or musculoskeletal disorders that preclude exercise test;
  • severe or decompensated heart disease.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02665546


Locations
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Brazil
InCor Heart Institute
Sao Paulo, Brazil, 05303900
Sponsors and Collaborators
InCor Heart Institute
Investigators
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Principal Investigator: Bruno G Baldi, md, PhD InCor Heart Institute
Publications:

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Responsible Party: Bruno Guedes Baldi, phD, InCor Heart Institute
ClinicalTrials.gov Identifier: NCT02665546    
Other Study ID Numbers: 4275/15/102
First Posted: January 27, 2016    Key Record Dates
Last Update Posted: March 1, 2019
Last Verified: February 2019
Keywords provided by Bruno Guedes Baldi, InCor Heart Institute:
Dyspnea
pulmonary hypertension
Histiocytosis Langerhans cells
exercise test
Additional relevant MeSH terms:
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Histiocytosis, Langerhans-Cell
Histiocytosis
Lymphatic Diseases
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases