Effect of Aerobic Training in Moderate or Severe Asthmatic Patients - Full Text View

Purpose

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.

Condition	Intervention	Phase
Asthma.	Other: Aerobic training Other: Breathing exercise	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	Effect of Aerobic Training on Bronchial Hyperresponsiveness and Systemic Inflammation in Patients With Moderate or Severe Asthma: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness

U.S. FDA Resources

Further study details as provided by Instituto de Investigação em Imunologia:

Primary Outcome Measures:

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).

Secondary Outcome Measures:

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

Other Outcome Measures:

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
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) .


Estimated Enrollment:	58
Study Start Date:	July 2012
Estimated Study Completion Date:	December 2014
Estimated Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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 .

Arms

Assigned Interventions

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 .

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


Ages Eligible for Study:	20 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02033122

Contacts


Contact: Pedro Giavina-Bianchi, MD, PhD	(11) 2661-0000 ext 6225	pbianchi@usp.br

Locations


Brazil
Hospital das Clínicas da FMUSP	Recruiting
São Paulo, Brazil
Contact: Pedro Giavina-Bianchi, MD, PhD pbianchi@usp.br
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: Beatriz M Saraiva-Romanholo, PhD
Sub-Investigator: Milton A Martins, MD
Sub-Investigator: Jorge Kalil, PhD
Principal Investigator: Celso RF Carvalho, PhD
Sub-Investigator: Regina M Carvalho-Pinto

Sponsors and Collaborators

Instituto de Investigação em Imunologia

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

França-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.


Responsible Party:	Instituto de Investigação em Imunologia
ClinicalTrials.gov Identifier:	NCT02033122 History of Changes
Other Study ID Numbers:	ETA1
Study First Received:	October 31, 2013
Last Updated:	January 9, 2014

Keywords provided by Instituto de Investigação em Imunologia:


exercise, bronchial hyperresponsiveness, inflammation

Additional relevant MeSH terms:


Asthma Bronchial Hyperreactivity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive	Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases

ClinicalTrials.gov processed this record on July 17, 2017

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