Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
40 participants
INTERVENTIONAL
2013-11-30
2015-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Pulmonary Rehabilitation
Control
No interventions assigned to this group
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Pulmonary Rehabilitation
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* Musculoskeletal disorders that would prevent the patient from performing exercise training
* Severe (NYHA IV) or uncontrolled heart disease
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Sao Paulo General Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Mariana Sponholz Araujo
Postgraduate student
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Mariana S Araujo, MD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Carlos RR Carvalho, PhD
Role: PRINCIPAL_INVESTIGATOR
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
São Paulo, São Paulo, Brazil
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
22729413.6.0000.0068
Identifier Type: -
Identifier Source: org_study_id