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

January 9, 2014 updated by: Instituto de Investigação em Imunologia

Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

58

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • São Paulo, Brazil
        • Recruiting
        • Hospital das Clínicas da FMUSP
        • Contact:
        • 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:
          • Jorge Kalil, PhD
        • Sub-Investigator:
          • Regina M Carvalho-Pinto

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 59 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Before and after 3 months of intervetion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Before and after 3 months of intervention

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
before and after 3 months of intervention
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) .
before and after 3 months of interventions

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Instituto de Investigação em Imunologia

Collaborators

University of Sao Paulo
Fundação de Amparo à Pesquisa do Estado de São Paulo

Investigators

  • Principal Investigator: Pedro Giavina-Bianchi, MD, PhD, Univeristy of São Paulo

Publications and helpful links

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General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2012

Primary Completion (Anticipated)

July 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

October 31, 2013

First Submitted That Met QC Criteria

January 9, 2014

First Posted (Estimate)

January 10, 2014

Study Record Updates

Last Update Posted (Estimate)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ETA1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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