Effect of Aerobic Training in Moderate or Severe Asthmatic Patients

Phase 3

• Conditions: Asthma.

• Registration Number: NCT02033122
• Lead Sponsor: 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.

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).

Study Timeline

• Study Start: 2012-07
• Study First Submitted: 2013-10-31
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10
• Primary Completion: 2014-07
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 58

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Bronchial hyperresponsiveness	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

Name	Time	Method
serum cytokines levels	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

Trial Locations

Locations (1)

Hospital das Clínicas da FMUSP; 🇧🇷 São Paulo, Brazil