Effect of Aerobic Training in Moderate or Severe Asthmatic Patients (ETA1)
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ClinicalTrials.gov Identifier: NCT02033122 |
Recruitment Status : Unknown
Verified January 2014 by Instituto de Investigação em Imunologia.
Recruitment status was: Recruiting
First Posted : January 10, 2014
Last Update Posted : January 10, 2014
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Condition or disease | Intervention/treatment | Phase |
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Asthma. | Other: Aerobic training Other: Breathing exercise | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 58 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Single (Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial |
Study Start Date : | July 2012 |
Estimated Primary Completion Date : | July 2014 |
Estimated Study Completion Date : | December 2014 |
Arm | Intervention/treatment |
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Active Comparator: Aerobic training
the intervention will be an aerobic training program. For the TG subjects, breathing exercises will have duration of 30 minutes and will be always followed by aerobic training sessions that will consist in 35 minutes divided in 5 minutes of warm-up, 25 minutes of aerobic training and 5 minutes of cool down. Initially, aerobic training will be performed at the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (AnT) and the respiratory compensation point (RCP) obtained in the incremental cardiopulmonary testing (CPET) and after two weeks of the adaptation, the intensity will increased to two thirds of the difference between AnT and RCP. The program will be performed twice a week, for 3 months.
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Other: Aerobic training
the intervention will be an aerobic training program. For the TG subjects, breathing exercises will have duration of 30 minutes and will be always followed by aerobic training sessions that will consist in 35 minutes divided in 5 minutes of warm-up, 25 minutes of aerobic training and 5 minutes of cool down. Initially, aerobic training will be performed at the heart rate (HR) corresponding to one third of the difference between the anaerobic threshold (AnT) and the respiratory compensation point (RCP) obtained in the incremental cardiopulmonary testing (CPET) and after two weeks of the adaptation, the intensity will increased to two thirds of the difference between AnT and RCP. The program will be performed twice a week, for 3 months. Other: Breathing exercise Patients from the control group will be taught breathing exercises with 30 min per session , twice a week , during 3 months. Every exercise will be performed in sets of 3 (2 min each) and 60 s of rest . |
Sham Comparator: Breathing exercise
Patients from the control group will be taught breathing exercises with 30 min per session , twice a week , during 3 months. Every exercise will be performed in sets of 3 (2 min each) and 60 s of rest .
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Other: Breathing exercise
Patients from the control group will be taught breathing exercises with 30 min per session , twice a week , during 3 months. Every exercise will be performed in sets of 3 (2 min each) and 60 s of rest . |
- Bronchial hyperresponsiveness [ Time Frame: Before and after 3 months of intervetion ]The bronchial provocation test will be conducted according to American Thoracic Society (ATS) guideline (1999). Patients will inhale increasing concentrations of histamine following the sequences: 0.0625, 0.25, 1.0, 4.0 and 16.0 mg/ ml using the method of the dosimeter (DeVilbiss 646nebulizer, DeVilbiss Health Care, USA) . Forced expiratory volume in one second (FEV1) will be measured after 30 and 90 seconds from the end of inhalations. The test will considered positive when the concentration of histamine promotes a fall ≥ 20% in FEV1 (PC20) with respect to the post-saline value or when the maximum concentration is reached (16 mg/mL).
- serum cytokines levels [ Time Frame: Before and after 3 months of intervention ]The plasma levels of inflammatory mediators will be evaluated before and after 3 months of intervention.The method Cytometric Beat Array (CBA) (BD Biosciences, USA) will be used to analyze the levels of interleukins (IL) IL-4, IL-5, IL-6, IL-8, IL -10, Tumor Necrosis Factor (TNF-α) and IL-12p70 and chemokines IL-8, Monocyte Chemotactic Protein-1 (MCP-1/CCL2) and RANTES
- Clinical control [ Time Frame: before and after 3 months of intervention ]Clinical control will be evaluated by daily symptoms dairy , exacerbation and asthma control questionnaire (ACQ) and
- Health related quality of life [ Time Frame: before and after 3 months of interventions ]Health related quality of life will be assessed by the Asthma Quality Life Questionnaire (AQLQ) .

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Ages Eligible for Study: | 20 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with moderate and severe persistent asthma
- Asthma will diagnosed according to Global Initiative for Asthma (GINA)
- Body Mass Index <35 kg/ m2
- Patients will submitted the medical treatment, followed by pulmonary specialists for at least 6 months.
Patients will considered clinically stable (i.e., no exacerbation or changes in medication for at least 30 days).
Exclusion Criteria:
- Patients will diagnosed with cardiovascular, musculoskeletal or other chronic lung diseases;
- Patients with current participation in exercise programs
- current smokers or ex-smokers will excluded from the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02033122
Contact: Pedro Giavina-Bianchi, MD, PhD | (11) 2661-0000 ext 6225 | pbianchi@usp.br |
Brazil | |
Hospital das Clínicas da FMUSP | Recruiting |
São Paulo, Brazil | |
Contact: Pedro Giavina-Bianchi, MD, PhD pbianchi@usp.br | |
Principal Investigator: Pedro Giavina-Bianchi, MD, PhD | |
Principal Investigator: Andrezza França-Pinto, PT | |
Principal Investigator: Felipe AR Mendes | |
Sub-Investigator: Rosana C Agondi | |
Sub-Investigator: Alberto Cukier | |
Sub-Investigator: Rafael Stelmach | |
Sub-Investigator: Beatriz M Saraiva-Romanholo, PhD | |
Sub-Investigator: Milton A Martins, MD | |
Sub-Investigator: Jorge Kalil, PhD | |
Principal Investigator: Celso RF Carvalho, PhD | |
Sub-Investigator: Regina M Carvalho-Pinto |
Principal Investigator: | Pedro Giavina-Bianchi, MD, PhD | Univeristy of São Paulo |
Responsible Party: | Instituto de Investigação em Imunologia |
ClinicalTrials.gov Identifier: | NCT02033122 |
Other Study ID Numbers: |
ETA1 |
First Posted: | January 10, 2014 Key Record Dates |
Last Update Posted: | January 10, 2014 |
Last Verified: | January 2014 |
exercise, bronchial hyperresponsiveness, inflammation |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |