LymphangioleiomyomatosisNCT02009241
Pulmonary Rehabilitation in Lymphangioleiomyomatosis
A study testing Pulmonary Rehabilitation in people with Lymphangioleiomyomatosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial 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). Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Lymphangioleiomyomatosis
- What is being tested?
- Pulmonary Rehabilitation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- Nov 2013to May 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Lung transplant recipients
- Musculoskeletal disorders that would prevent the patient from performing exercise training
- Severe (NYHA IV) or uncontrolled heart disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
São Paulo, São Paulo, 05403-000
About this study
Official title: 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.
- Conditions
- Lymphangioleiomyomatosis
- Being tested
- Pulmonary Rehabilitation
- Keywords
- Lymphangioleiomyomatosis, Rehabilitation, Exercise
- Medical subject headings
- Lymphangioleiomyomatosis, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pulmonary RehabilitationOther
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Pulmonary Rehabilitation |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endurance time during constant work rate cycle ergometry
Measured: 12 weeks
Secondary outcomes (10)
Peak oxygen consumption (VO2 peak) during constant work rate cycle ergometry
Measured: 12 weeks
Dynamic hyperinflation and ventilatory parameters during constant work rate cycle ergometry
Measured: 12 weeks
Dyspnea and fatigue in the lower limbs during constant work rate cycle ergometry
Measured: 12 weeks
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
Measured: 12 weeks
Health factors related to quality of life
St. George's Respiratory Questionnaire (SGRQ) pre - and post - intervention
Measured: 12 weeks
Anxiety and depression
Hospital Anxiety and Depression Scale (HADS) performed pre - and post - intervention
Measured: 12 weeks
Daily physical activity
Evaluated using a pedometer for one week pre - and post - intervention
Measured: 12 weeks
Changes in six minute walking distance and in desaturation - distance ratio (DDR)
Measured: 12 weeks
Changes in pulmonary function parameters
Measured: 12 weeks
Changes in peripheral muscle force
Using one repetition maximum (1 RM) pre - and post - intervention
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2015
- Study completionMay 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LymphangioleiomyomatosisStudies of the same condition, open and under way.
- More trials run by University of Sao Paulo General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mariana Sponholz Araujo, University of Sao Paulo General Hospital
- Investigators
- Mariana S Araujo, MD, Principal investigator, Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical SchoolCarlos RR Carvalho, PhD, Principal investigator, Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02009241
- Sponsor's protocol ID
- 22729413.6.0000.0068
- Status last verified
- Dec 2015
- First submitted
- 4 Dec 2013
- Last updated
- 11 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26917604
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of a Pulmonary Rehabilitation Program on Exercise Capacity in Patients With Lymphangioleiomyomatosis
- ClinicalTrials.gov ID
- NCT02009241
- Acronym / sponsor ID
- 22729413.6.0000.0068
- Conditions
- Lymphangioleiomyomatosis
- Keywords
- Lymphangioleiomyomatosis, Rehabilitation, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Study start
- Nov 2013
- Primary completion
- Apr 2015 (actual)
- Study completion
- May 2015 (actual)
- First posted
- 11 Dec 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Rehabilitation | Active comparator | Other: Pulmonary RehabilitationThe 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. |
| Control | No intervention | – |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Lung transplant recipients
- Musculoskeletal disorders that would prevent the patient from performing exercise training
- Severe (NYHA IV) or uncontrolled heart disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pulmonary Rehabilitation | Other | Pulmonary Rehabilitation |
Primary outcome
Endurance time during constant work rate cycle ergometry
Time frame: 12 weeks
10 secondary outcomes
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
Health factors related to quality of life
Time frame: 12 weeks
Anxiety and depression
Time frame: 12 weeks
Daily physical activity
Time frame: 12 weeks
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2015.
- Derived from this study: PubMed 26917604Araujo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mariana S Araujo, MD principal investigator
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
Carlos RR Carvalho, PhD principal investigator
Pulmonary Division, Heart Institute (InCor), University of Sao Paulo Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pulmonary Rehabilitation in people with Lymphangioleiomyomatosis, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Endurance time during constant work rate cycle ergometry (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02009241, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2015.