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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

Tracking Information
First Submitted Date  ICMJE December 4, 2013
First Posted Date  ICMJE December 11, 2013
Last Update Posted Date December 11, 2015
Study Start Date  ICMJE November 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 8, 2013)
Endurance time during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 8, 2013)
  • Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  • Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  • Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry [ Time Frame: 12 weeks ]
  • 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
  • Health factors related to quality of life [ Time Frame: 12 weeks ]
    St. George's Respiratory Questionnaire (SGRQ) pre - and post - intervention
  • Anxiety and depression [ Time Frame: 12 weeks ]
    Hospital Anxiety and Depression Scale (HADS) performed pre - and post - intervention
  • Daily physical activity [ Time Frame: 12 weeks ]
    Evaluated using a pedometer for one week pre - and post - intervention
  • Changes in six minute walking distance and in desaturation - distance ratio (DDR) [ Time Frame: 12 weeks ]
  • Changes in pulmonary function parameters [ Time Frame: 12 weeks ]
  • Changes in peripheral muscle force [ Time Frame: 12 weeks ]
    Using one repetition maximum (1 RM) pre - and post - intervention
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Pulmonary Rehabilitation in Lymphangioleiomyomatosis
Official Title  ICMJE Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Lymphangioleiomyomatosis
Intervention  ICMJE Other: Pulmonary Rehabilitation
Study Arms  ICMJE
  • 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.
    Intervention: Other: Pulmonary Rehabilitation
  • No Intervention: Control
Publications * Araujo MS, Baldi BG, Freitas CS, Albuquerque AL, Marques da Silva CC, Kairalla RA, Carvalho CR, Carvalho CR. Pulmonary rehabilitation in lymphangioleiomyomatosis: a controlled clinical trial. Eur Respir J. 2016 May;47(5):1452-60. doi: 10.1183/13993003.01683-2015. Epub 2016 Feb 25.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: December 9, 2015)
40
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2013)
30
Actual Study Completion Date  ICMJE May 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Brazil
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02009241
Other Study ID Numbers  ICMJE 22729413.6.0000.0068
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mariana Sponholz Araujo, University of Sao Paulo General Hospital
Study Sponsor  ICMJE University of Sao Paulo General Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account University of Sao Paulo General Hospital
Verification Date December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP