Effect of Aerobic Training in Moderate or Severe Asthmatic Patients

NCT02033122 | Unknown Phase 3

• 1 other identifier: ETA1
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Asthma.

Keywords

exercise, bronchial hyperresponsiveness, inflammation

Outcome Measures

Primary Outcomes (1)

• Bronchial hyperresponsiveness

  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).

  Before and after 3 months of intervetion

Secondary Outcomes (1)

• serum cytokines levels

  Before and after 3 months of intervention

Other Outcomes (2)

• Clinical control

  before and after 3 months of intervention

• Health related quality of life

  before and after 3 months of interventions

Study Arms (2)

Aerobic training

ACTIVE COMPARATOR

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; Other: Breathing exercise

Breathing exercise

SHAM COMPARATOR

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

Interventions

Aerobic training OTHER

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.

Aerobic training

Breathing exercise OTHER

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 .

Aerobic training; Breathing exercise

Eligibility Criteria

• Age: 20 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Instituto de Investigação em Imunologia: lead
• University of Sao Paulo: collaborator
• Fundação de Amparo à Pesquisa do Estado de São Paulo: collaborator

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 26063507 DERIVED

MeSH Terms

Conditions

Asthma; Motor Activity; Bronchial Hyperreactivity; Inflammation

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Pedro Giavina-Bianchi, MD, PhD

  Univeristy of São Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pedro Giavina-Bianchi, MD, PhD

CONTACT

(11) 2661-0000; pbianchi@usp.br

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2013
• First Posted: January 10, 2014
• Study Start: July 1, 2012
• Primary Completion: July 1, 2014
• Study Completion: December 1, 2014
• Last Updated: January 10, 2014

Record last verified: 2014-01

Locations

BR (1)