Clinical trial NCT02489383: Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients
Official title: Comparison to Short and Medium-term Effects of Continuous and Interval Aerobic Exercise Training in Improving Aerobic Capacity, Psychosocial Factors and Impact on the Level of Physical Activity in Patients With Asthma Moderate and Severe
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Asthma
Keywords: Asthma
Continuous Exercise Training
interval Exercise Training
Clinical Control
Inflammation
Lead sponsor: University of Sao Paulo General Hospital
Sponsor class: OTHER
Collaborators: name: University of Sao Paulo
name: Fundação de Amparo à Pesquisa do Estado de São Paulo
name: Conselho Nacional de Desenvolvimento Científico e Tecnológico
First posted: 2015-07-03
Enrollment: 60
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: The treatment of asthma is based in clinical control. However, previous studies have been shown that patients that participate of the programs of regular or aerobic continuous exercise training (CT) presented improvements in the physical conditioning, and quality life, as well as decreased the levels of anxiety and depression, reduced the oxide nitric exhaled and leukocyte migration at the airways and reduced the airway hyperresponsiveness. The regular exercise also is important part in the rehabilitation of other lung disease as well as chronic obstructive pulmonary disease (COPD). Additionally, others studies have been shown the effects of high intensity interval training (IT) in the pulmonary rehabilitation of COPD patients, that after performed IT presented reduction of dyspnea, and increase the physical capacity. In this sense, the impact of IT in the asthmatic patients at the present moment is poorly studied, and necessity of the more investigation to prove the efficiency of this training model for asthma patients.

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Detailed description: The present study will compare the impact of IT and CT in patients with moderate or severe asthma, and investigate what is the most efficient and increases the physical capacity, and quality of life and reduces the inflammatory mediators.

Sixty asthmatic adults will be randomly assigned into two groups: CT (Continuous training) or IT (Interval training). CT will have treatment 2x week, 40 min./session, 60-75% of maximum heart rate intensity and IT also 2x week, 40 min./session, 80-140% of the maximum load intensity, both performed in ergometer cycle by 24 weeks.

Eligibility criteria: Inclusion Criteria:

* Asthma moderate and severe
* Asthma will diagnosed (Global Initiative for Asthma - GINA)
* Body Mass Index (BMI) \< 35kg/m2
* Medical Treatment for at least 6 months
* Clinically stable (i.e., no exacerbation or medication changes for at least 30 days)

Exclusion Criteria:

* Cardiovascular, musculoskeletal or other different chronic lung diseases
* Active cancer
* Pregnant
* Smokers

Primary outcomes:
measure: Endurance test
timeFrame: After 3 months of intervention
Secondary outcomes:
measure: Nitric oxide exhaled measurement
timeFrame: Before and after 3 months of intervention
measure: Quantification of Inflammatory mediators
timeFrame: Before and after 3 months of intervention
measure: Analysis of cortisol in the serum
timeFrame: Before and after 3 months of intervention
measure: Level of physical activity
timeFrame: Before and after 3 months of intervention, and after 3 months of follow up
measure: Clinical Control
timeFrame: Before and after 3 months os intervention, ans after 3 months of follow up
measure: Health related quality of life
timeFrame: Before and after 3 months os intervention, and after 3 months of follow up
measure: Level of depression and anxiety
timeFrame: Before and after 3 months os intervention, and after 3 months of follow up
measure: Lung function
timeFrame: Before and after 3 months os intervention, and after 3 months of follow up
measure: Physical capacity
timeFrame: Before and after 3 months os intervention
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Physical Therapy, and Clinical Hospital of Sao Paulo University Medical School (HCFMUSP)
city: São Paulo
country: Brazil
facility: Hospital das Clínicas da Faculadade de Medicina da USP
Study officials:
affiliation: University of São Paulo General Hospital
name: Celso RF Carvalho, PhD
role: PRINCIPAL_INVESTIGATOR
References: