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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
Sponsor:
Collaborators:
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Information provided by (Responsible Party):
Instituto de Investigação em Imunologia

Brief Summary:
Exercise training has been proposed as adjunctive therapy in asthma to improve many clinical outcomes; however its effects on bronchial hyperresponsiveness (BHR) and inflammation, characteristic features in asthma, remains poorly understood. We aim to investigate the effects of aerobic training on BHR (primary aim) and systemic inflammation (secondary aim). In addition, clinical control and health related quality of life (HRQoL) will be also assessed.

Condition or disease Intervention/treatment Phase
Asthma. Other: Aerobic training Other: Breathing exercise Phase 3

Detailed Description:
This is a randomized, controlled and single-blind trial whose intervention will be an aerobic training. Fifty -eight patients with moderate or severe persistent asthma will be recruited at a university hospital and randomly assigned in two groups: control (CG) or training (TG) .The study will be performed between two medical visits with intervals of six months and during this period the same medication dosage will be maintained. Patients in CG will perform (an educational program + breathing exercise; n=28) and TG patients will perform (an educational program+breathing exercises+aerobic training; n=30).The sessions will be conducted twice a week, for 3 months. Before and after the intervention, all patients will be evaluated by bronchial hyperresponsiveness, serum cytokines levels, total immunoglobulin E, induced sputum, fractional exhaled nitric oxide (FeNO), asthma clinical control (daily symptoms dairy, exacerbations and asthma control questionnaire - ACQ), health related quality of life (HRQoL); asthma quality of life questionnaire-(AQLQ), pulmonary function and cardiopulmonary exercise testing. All the patients will be evaluated by specific immunoglobulin E (atopy) through (skin prick test or Phadiatop).

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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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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 .
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 .




Primary Outcome Measures :
  1. 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).


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. 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

  2. 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
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Pedro Giavina-Bianchi, MD, PhD (11) 2661-0000 ext 6225 pbianchi@usp.br

Locations
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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         
Sponsors and Collaborators
Instituto de Investigação em Imunologia
University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo
Investigators
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Principal Investigator: Pedro Giavina-Bianchi, MD, PhD Univeristy of São Paulo

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier: NCT02033122     History of Changes
Other Study ID Numbers: ETA1
First Posted: January 10, 2014    Key Record Dates
Last Update Posted: January 10, 2014
Last Verified: January 2014
Keywords provided by Instituto de Investigação em Imunologia:
exercise, bronchial hyperresponsiveness, inflammation
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases