Effect of Aerobic Training in Moderate or Severe Asthmatic Patients

NCT ID: NCT02033122

Last Updated: 2014-01-10

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE3
• Total Enrollment: 58 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-07-31
• Study Completion Date: 2014-12-31

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).

Conditions

Asthma.

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Aerobic training

Intervention Type: 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.

Breathing exercise

Intervention Type: 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 .

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 .

Group Type: SHAM_COMPARATOR

Breathing exercise

Intervention Type: 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 .

Interventions

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.

Intervention Type: 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 .

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo

OTHER

Sponsor Role: collaborator

Fundação de Amparo à Pesquisa do Estado de São Paulo

OTHER_GOV

Sponsor Role: collaborator

Instituto de Investigação em Imunologia

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Pedro Giavina-Bianchi, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Univeristy of São Paulo

Locations

Hospital das Clínicas da FMUSP

São Paulo, , Brazil

Site Status: RECRUITING

Countries

Brazil

Central Contacts

Pedro Giavina-Bianchi, MD, PhD

Role: CONTACT

pbianchi@usp.br

(11) 2661-0000 ext. 6225

Facility Contacts

Pedro Giavina-Bianchi, MD, PhD

Role: primary

pbianchi@usp.br

References

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.

Reference Type: DERIVED

PMID: 26063507 (View on PubMed)

Other Identifiers

ETA1

Identifier Type: -

Identifier Source: org_study_id