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Pulmonary Rehabilitation in Lymphangioleiomyomatosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02009241
Recruitment Status : Completed
First Posted : December 11, 2013
Last Update Posted : December 11, 2015
Sponsor:
Information provided by (Responsible Party):
Mariana Sponholz Araujo, University of Sao Paulo General Hospital

Brief Summary:

Lymphangioleiomyomatosis (LAM) is a rare disease in which reduced exercise capacity is frequently present. The mechanisms applied are airflow obstruction, abnormal diffusion capacity and dynamic hyperinflation (DH).

Pulmonary rehabilitation (PR) has proved benefit in improving exercise tolerance, dyspnea, and quality of life in chronic obstructive pulmonary disease. There are no studies evaluating the impact of PR in patients with LAM.

The hypothesis under study is that PR determine improvement in exercise capacity, dyspnea, quality of life, muscle force, functional limitation and DH in these patients.


Condition or disease Intervention/treatment Phase
Lymphangioleiomyomatosis Other: Pulmonary Rehabilitation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis
Study Start Date : November 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : May 2015


Arm Intervention/treatment
Active Comparator: Pulmonary Rehabilitation
The intervention group will perform a 12 week pulmonary rehabilitation program consisting of 30 minutes of treadmill aerobic exercise training and 30 minutes of muscle strength training.
Other: Pulmonary Rehabilitation
No Intervention: Control



Primary Outcome Measures :
  1. Endurance time during constant work rate cycle ergometry [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  2. Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  3. Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  4. Dyspnea and functional disability related to daily life activities [ Time Frame: 12 weeks ]
    The Modified Medical Research Council Dyspnea Scale (mMRC) and Baseline Dyspnea Index (BDI) will be evaluated pre - and post - intervention

  5. Health factors related to quality of life [ Time Frame: 12 weeks ]
    St. George's Respiratory Questionnaire (SGRQ) pre - and post - intervention

  6. Anxiety and depression [ Time Frame: 12 weeks ]
    Hospital Anxiety and Depression Scale (HADS) performed pre - and post - intervention

  7. Daily physical activity [ Time Frame: 12 weeks ]
    Evaluated using a pedometer for one week pre - and post - intervention

  8. Changes in six minute walking distance and in desaturation - distance ratio (DDR) [ Time Frame: 12 weeks ]
  9. Changes in pulmonary function parameters [ Time Frame: 12 weeks ]
  10. Changes in peripheral muscle force [ Time Frame: 12 weeks ]
    Using one repetition maximum (1 RM) pre - and post - intervention



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosis of lymphangioleiomyomatosis established by tissue biopsy and / or a combination of history and high-resolution computed tomography scanning
  • Clinical stability, defined as no exacerbations or hospitalizations related to the underlying disease for a minimum of 6 weeks and no change in the treatment regimen in the last 3 months
  • Low level of physical activity, defined as patients who walk less than 10 thousand daily steps and / or are not performing regular physical activity for at least 4 months before the start of rehabilitation
  • Signature of the free, prior and informed consent for participation in the study

Exclusion Criteria:

  • Lung transplant recipients
  • Musculoskeletal disorders that would prevent the patient from performing exercise training
  • Severe (NYHA IV) or uncontrolled 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): NCT02009241


Locations
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Brazil
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Sao Paulo, SP, Brazil, 05403-000
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Mariana S Araujo, MD Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Principal Investigator: Carlos RR Carvalho, PhD Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Mariana Sponholz Araujo, Postgraduate student, University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT02009241    
Other Study ID Numbers: 22729413.6.0000.0068
First Posted: December 11, 2013    Key Record Dates
Last Update Posted: December 11, 2015
Last Verified: December 2015
Keywords provided by Mariana Sponholz Araujo, University of Sao Paulo General Hospital:
Lymphangioleiomyomatosis
Rehabilitation
Exercise
Additional relevant MeSH terms:
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Lymphangioleiomyomatosis
Lymphangiomyoma
Lymphatic Vessel Tumors
Neoplasms by Histologic Type
Neoplasms
Perivascular Epithelioid Cell Neoplasms
Neoplasms, Connective and Soft Tissue
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases