Clinical trial NCT02033122: Effect of Aerobic Training in Moderate or Severe Asthmatic Patients
Official title: Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Asthma.
Keywords: exercise, bronchial hyperresponsiveness, inflammation
Lead sponsor: Instituto de Investigação em Imunologia
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
First posted: 2014-01-10
Enrollment: 58
Sex: ALL
Minimum age (years): 20
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility 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.

Primary outcomes:
measure: Bronchial hyperresponsiveness
timeFrame: Before and after 3 months of intervetion
Secondary outcomes:
measure: serum cytokines levels
timeFrame: Before and after 3 months of intervention
Other outcomes:
measure: Clinical control
timeFrame: before and after 3 months of intervention
measure: Health related quality of life
timeFrame: before and after 3 months of interventions
Locations:
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da FMUSP
Study officials:
affiliation: Univeristy of São Paulo
name: Pedro Giavina-Bianchi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Franca-Pinto A, Mendes FA, de Carvalho-Pinto RM, Agondi RC, Cukier A, Stelmach R, Saraiva-Romanholo BM, Kalil J, Martins MA, Giavina-Bianchi P, Carvalho CR. Aerobic training decreases bronchial hyperresponsiveness and systemic inflammation in patients with moderate or severe asthma: a randomised controlled trial. Thorax. 2015 Aug;70(8):732-9. doi: 10.1136/thoraxjnl-2014-206070. Epub 2015 Jun 10.