AnxietyNCT00989365
Effect of Aerobic Training on Asthmatic Patients
A study testing Aerobic training in people with Anxiety and Depression, run by University of Sao Paulo General Hospital at 1 site in Brazil.
Trial summary
The investigators hypothesize that aerobic training can reduce anxiety, depression and airway inflammation and those benefits may be related to changes in autonomic system. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Anxiety, Depression, Airway Inflammation
- What is being tested?
- Aerobic training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteBrazil
- Study dates
- Jan 2007to Sep 2009
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 20-50 years old
- moderate and severe asthma
Who cannot join
- other pulmonary or cardiovascular disease
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Clinical Hospital, School of Medicine, University of São Paulo
São Paulo, São Paulo, 05403-000
About this study
Official title: Effect of Aerobic Training on Psychosocial Morbidity, Symptoms, Airway Inflammation and Autonomic Modulation in Asthmatic Patients
The investigators hypothesize that aerobic training can reduce anxiety, depression and airway inflammation and those benefits may be related to changes in autonomic system.
Read the detailed description
One-hundred patients with moderate or severe persistent asthma, age ranging from 20 to 50 years-old recruited after a medical consultation. Asthma diagnosis based on GINA1 and patients were under medical treatment for at least 6-months and considered clinically stable (no crises and changes in medication for at least 30 days). Patients diagnosed with cardiovascular, pulmonary or musculoskeletal diseases impairing exercise training were excluded.
Experimental Design: Patients were studied between 2 medical consultation to avoid changes in medication during the study and patients were randomized (by drawing lots) into either Control or Training groups. CG was submitted to a 4-hour educational program and a breathing exercise program and TG was submitted to the same CG procedures plus an aerobic training program individually based on VO2max. Before and after the intervention, patients performed pulmonary function test and cardiopulmonary exercise testing and as well as fulfilled questionnaires to quantify asthma specific HRQL and anxiety and depression levels. Asthma daily symptoms were evaluated monthly.
- Conditions
- Anxiety, Depression, Airway Inflammation
- Being tested
- Aerobic training
- Keywords
- Aerobic Exercise, Exercise
- Medical subject headings
- Anxiety Disorders, Depression, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aerobic trainingOther
Also called Exercise conditioning
Treadmill training
| Study group | Role | What they receive |
|---|---|---|
| Patient cousenling | Other | Improve medicine use Self control asthma crisis Ambient hygiene Receives: Other: Aerobic training |
What is being measured
The primary outcome is the main question the study is designed to answer.
psychosocial morbidity and airway inflammation
Measured: 3 months
Secondary outcomes (1)
autonomic modulation, aerobic capacity, pulmonary function
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2009 (estimated)
- Study startJan 2007
- Primary completionSep 2009
- Study completionSep 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AnxietyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Laboratório de Investigação Médica
- Investigators
- Celso RF Carvalho, PhD, Study chair, School of Medicine, University of São Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00989365
- Sponsor's protocol ID
- Asthmatraining
- Status last verified
- Oct 2009
- First submitted
- 2 Oct 2009
- Last updated
- 5 Oct 2009
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fanelli A, Cabral AL, Neder JA, Martins MA, Carvalho CR. Exercise training on disease control and quality of life in asthmatic children. Med Sci Sports Exerc. 2007 Sep;39(9):1474-80. doi: 10.1249/mss.0b013e3180d099ad.
PubMed 17805077Mendes FA, Goncalves RC, Nunes MP, Saraiva-Romanholo BM, Cukier A, Stelmach R, Jacob-Filho W, Martins MA, Carvalho CR. Effects of aerobic training on psychosocial morbidity and symptoms in patients with asthma: a randomized clinical trial. Chest. 2010 Aug;138(2):331-7. doi: 10.1378/chest.09-2389. Epub 2010 Apr 2.
PubMed 20363839
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Aerobic Training on Psychosocial Morbidity, Symptoms, Airway Inflammation and Autonomic Modulation in Asthmatic Patients
- ClinicalTrials.gov ID
- NCT00989365
- Acronym / sponsor ID
- Asthmatraining
- Conditions
- Anxiety, Depression, Airway Inflammation
- Keywords
- Aerobic Exercise, Exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Conselho Nacional de Desenvolvimento Científico e Tecnológico, Laboratório de Investigação Médica
- Study start
- Jan 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2009 (actual)
- First posted
- 5 Oct 2009 (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.
The investigators hypothesize that aerobic training can reduce anxiety, depression and airway inflammation and those benefits may be related to changes in autonomic system.
Detailed description
One-hundred patients with moderate or severe persistent asthma, age ranging from 20 to 50 years-old recruited after a medical consultation. Asthma diagnosis based on GINA1 and patients were under medical treatment for at least 6-months and considered clinically stable (no crises and changes in medication for at least 30 days). Patients diagnosed with cardiovascular, pulmonary or musculoskeletal diseases impairing exercise training were excluded.
Experimental Design: Patients were studied between 2 medical consultation to avoid changes in medication during the study and patients were randomized (by drawing lots) into either Control or Training groups. CG was submitted to a 4-hour educational program and a breathing exercise program and TG was submitted to the same CG procedures plus an aerobic training program individually based on VO2max. Before and after the intervention, patients performed pulmonary function test and cardiopulmonary exercise testing and as well as fulfilled questionnaires to quantify asthma specific HRQL and anxiety and depression levels. Asthma daily symptoms were evaluated monthly.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patient cousenling | Other | Other: Aerobic trainingImprove medicine use Self control asthma crisis Ambient hygiene |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 20-50 years old
- moderate and severe asthma
Key exclusion criteria (1 listed)
- other pulmonary or cardiovascular 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 |
|---|---|---|
| Aerobic trainingAlso: Exercise conditioningTreadmill training | Other | Patient cousenling |
Primary outcome
psychosocial morbidity and airway inflammation
Time frame: 3 months
1 secondary outcome
autonomic modulation, aerobic capacity, pulmonary function
Time frame: 3 months
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 5 Oct 2009.
- Background: PubMed 17805077Fanelli A, Cabral AL, Neder JA, Martins MA, Carvalho CR. Exercise training on disease control and quality of life in asthmatic children. Med Sci Sports Exerc. 2007 Sep;39(9):1474-80. doi: 10.1249/mss.0b013e3180d099ad.
- Derived from this study: PubMed 20363839Mendes FA, Goncalves RC, Nunes MP, Saraiva-Romanholo BM, Cukier A, Stelmach R, Jacob-Filho W, Martins MA, Carvalho CR. Effects of aerobic training on psychosocial morbidity and symptoms in patients with asthma: a randomized clinical trial. Chest. 2010 Aug;138(2):331-7. doi: 10.1378/chest.09-2389. Epub 2010 Apr 2.
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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.
Celso RF Carvalho, PhD study chair
School of Medicine, University of São Paulo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aerobic training in people with Anxiety and Depression, 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 2 inclusion and 1 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 5 Oct 2009. 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?
psychosocial morbidity and airway inflammation (time frame: 3 months). 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 NCT00989365, which also lists 2 linked publications.
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 5 Oct 2009.