Effect of Aerobic Training in Moderate or Severe Asthmatic Patients (ETA1)

Instituto de Investigação em Imunologia

Status and phase: Unknown; Phase 3

Conditions: Asthma.

Treatments: Other: Breathing exercise; Other: Aerobic training

Study type: Interventional

Funder types: Other

Identifiers

NCT02033122

ETA1

Details and patient eligibility

About

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.

Full 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).

Enrollment: 58 estimated patients

Sex: All

Ages: 20 to 59 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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58 participants in 2 patient groups

Aerobic training

Active Comparator group

Description:

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.

Treatment:

Other: Aerobic training

Other: Breathing exercise

Breathing exercise

Sham Comparator group

Description:

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 .

Treatment:

Other: Breathing exercise