Pulmonary Rehabilitation in Lymphangioleiomyomatosis

December 9, 2015 updated by: Mariana Sponholz Araujo, University of Sao Paulo General Hospital

Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • SP
      • Sao Paulo, SP, Brazil, 05403-000
        • Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SUPPORTIVE_CARE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
NO_INTERVENTION: Control
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Endurance time during constant work rate cycle ergometry
Time Frame: 12 weeks
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry
Time Frame: 12 weeks
12 weeks
Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry
Time Frame: 12 weeks
12 weeks
Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry
Time Frame: 12 weeks
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
12 weeks
Health factors related to quality of life
Time Frame: 12 weeks
St. George's Respiratory Questionnaire (SGRQ) pre - and post - intervention
12 weeks
Anxiety and depression
Time Frame: 12 weeks
Hospital Anxiety and Depression Scale (HADS) performed pre - and post - intervention
12 weeks
Daily physical activity
Time Frame: 12 weeks
Evaluated using a pedometer for one week pre - and post - intervention
12 weeks
Changes in six minute walking distance and in desaturation - distance ratio (DDR)
Time Frame: 12 weeks
12 weeks
Changes in pulmonary function parameters
Time Frame: 12 weeks
12 weeks
Changes in peripheral muscle force
Time Frame: 12 weeks
Using one repetition maximum (1 RM) pre - and post - intervention
12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Sao Paulo General Hospital

Investigators

  • 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 and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (ACTUAL)

April 1, 2015

Study Completion (ACTUAL)

May 1, 2015

Study Registration Dates

First Submitted

December 4, 2013

First Submitted That Met QC Criteria

December 8, 2013

First Posted (ESTIMATE)

December 11, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

December 11, 2015

Last Update Submitted That Met QC Criteria

December 9, 2015

Last Verified

December 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 22729413.6.0000.0068

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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