NCT02009241

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 4, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

December 11, 2013

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2015

Completed
Last Updated

December 11, 2015

Status Verified

December 1, 2015

Enrollment Period

1.4 years

First QC Date

December 4, 2013

Last Update Submit

December 9, 2015

Conditions

Lymphangioleiomyomatosis

Keywords

LymphangioleiomyomatosisRehabilitationExercise

Outcome Measures

Primary Outcomes (1)

  • Endurance time during constant work rate cycle ergometry

    12 weeks

Secondary Outcomes (10)

  • Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry

    12 weeks

  • Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry

    12 weeks

  • Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry

    12 weeks

  • Dyspnea and functional disability related to daily life activities

    12 weeks

  • Health factors related to quality of life

    12 weeks

  • +5 more secondary outcomes

Study Arms (2)

Pulmonary Rehabilitation

ACTIVE COMPARATOR

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

Control

NO INTERVENTION

Interventions

Pulmonary RehabilitationOTHER
Pulmonary Rehabilitation

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 26917604DERIVED

MeSH Terms

Conditions

LymphangioleiomyomatosisMotor Activity

Condition Hierarchy (Ancestors)

LymphangiomyomaNeoplasm, Lymphatic TissueNeoplasms by Histologic TypeNeoplasmsPerivascular Epithelioid Cell NeoplasmsNeoplasms, Connective and Soft TissueLymphoproliferative DisordersLymphatic DiseasesHemic and Lymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesBehavior

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Postgraduate student

Study Record Dates

First Submitted

December 4, 2013

First Posted

December 11, 2013

Study Start

November 1, 2013

Primary Completion

April 1, 2015

Study Completion

May 1, 2015

Last Updated

December 11, 2015

Record last verified: 2015-12

Locations

BR(1)