search
Back to results

Pulmonary Rehabilitation in Lymphangioleiomyomatosis

Primary Purpose

Lymphangioleiomyomatosis

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Pulmonary Rehabilitation
Sponsored by
University of Sao Paulo General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Lymphangioleiomyomatosis focused on measuring Lymphangioleiomyomatosis, Rehabilitation, Exercise

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Pulmonary Rehabilitation

Control

Arm Description

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.

Outcomes

Primary Outcome Measures

Endurance time during constant work rate cycle ergometry

Secondary Outcome Measures

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

Full Information

First Posted
December 4, 2013
Last Updated
December 9, 2015
Sponsor
University of Sao Paulo General Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT02009241
Brief Title
Pulmonary Rehabilitation in Lymphangioleiomyomatosis
Official Title
Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis
Study Type
Interventional

2. Study Status

Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
November 2013 (undefined)
Primary Completion Date
April 2015 (Actual)
Study Completion Date
May 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphangioleiomyomatosis
Keywords
Lymphangioleiomyomatosis, Rehabilitation, Exercise

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pulmonary Rehabilitation
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Pulmonary Rehabilitation
Primary Outcome Measure Information:
Title
Endurance time during constant work rate cycle ergometry
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry
Time Frame
12 weeks
Title
Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry
Time Frame
12 weeks
Title
Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry
Time Frame
12 weeks
Title
Dyspnea and functional disability related to daily life activities
Description
The Modified Medical Research Council Dyspnea Scale (mMRC) and Baseline Dyspnea Index (BDI) will be evaluated pre - and post - intervention
Time Frame
12 weeks
Title
Health factors related to quality of life
Description
St. George's Respiratory Questionnaire (SGRQ) pre - and post - intervention
Time Frame
12 weeks
Title
Anxiety and depression
Description
Hospital Anxiety and Depression Scale (HADS) performed pre - and post - intervention
Time Frame
12 weeks
Title
Daily physical activity
Description
Evaluated using a pedometer for one week pre - and post - intervention
Time Frame
12 weeks
Title
Changes in six minute walking distance and in desaturation - distance ratio (DDR)
Time Frame
12 weeks
Title
Changes in pulmonary function parameters
Time Frame
12 weeks
Title
Changes in peripheral muscle force
Description
Using one repetition maximum (1 RM) pre - and post - intervention
Time Frame
12 weeks

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mariana S Araujo, MD
Organizational Affiliation
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Carlos RR Carvalho, PhD
Organizational Affiliation
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil

12. IPD Sharing Statement

Citations:
PubMed Identifier
26917604
Citation
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.
Results Reference
derived

Learn more about this trial

Pulmonary Rehabilitation in Lymphangioleiomyomatosis

We'll reach out to this number within 24 hrs