Comparison Between Continuous Versus Interval Exercise Training in Asthmatic Patients

Study Overview
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Brief Summary
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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. .

Detailed Description
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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.

Official Title
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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

Conditions
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Asthma

Intervention / Treatment
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* Other: Continuous Exercise Training
* Other: Interval Exercise Training
* Behavioral: Education Program


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 59 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Continuous Exercise Training<br>The interventions of active comparator will be education program and exercise training. | Other: Continuous Exercise Training<br>* The continuous training (CT) will be held in two weekly sessions lasting total of 40 minutes and 5 minutes for heating and 5 to slowdown, and the duration will be 24 sessions (3 months). The exercise sessions will be will be performed on a stationary bicycle, with the initial intensity of 70% of VO2max. If the subject sustain continuously training intensity for 2 consecutive sessions without symptoms breathing, exercise intensity will be increased by 5% of heart rate. The patient may stop the activity if he has any symptoms or respiratory distress, returning it as soon present improvement. Throughout the training, will be monitored heart rate and the level of perception subjective effort (modified Borg scale).<br>Behavioral: Education Program<br>* The education program will discuss issues related to asthma and physical activity. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peak flow meter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.<br>|
| Active Comparator: Interval Exercise Training<br>The interventions of active comparator will be education program and exercise training. | Other: Interval Exercise Training<br>* The interval training (IT) will be held in two weekly sessions. The IT is individualized and will be performed on a stationary bicycle. Training sessions will be performed with total duration of 40 minutes consisting of 5 minutes extender, 30 minutes from the main part (IT), finishing with five minutes back to calm. In the main part (of 5 to 30 minutes), the patient will perform the exercise with high intensity in the first two weeks, the exercise will be conducted with an intensity 80% of maximum capacity obtained in cycle ergometer test and will cycle for 30 seconds followed by a 30 second recovery period. In the 3rd and 4th weeks, the intensity will be increased to 100% of the maximum obtained. After this period, the intensity will be increased by 5% charge.<br>Behavioral: Education Program<br>* The education program will discuss issues related to asthma and physical activity. Presentations and group discussions will be carried out, including information about asthma pathophysiology, medication and peak flow meter skills, self-monitoring techniques, environmental control, benefits and current recommendations of physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endurance test | Measurements at isotime: at identical work rates before and after training, heart rate, perception exertion and dyspnea. | After 3 months of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nitric oxide exhaled measurement | The level of nitric oxide exhaled (FEno) in the patients with asthma will be quantified with use of the equipment Niox Mino (Niox, Solna, Sweden). | Before and after 3 months of intervention | 
| Quantification of Inflammatory mediators | The levels of inflammatory mediators interleukin (IL)-4, IL-5, IL-6, IL-8, IL-2, IL-12, IL-17, Interferon gamma (IFN-γ), Tumor necrosis factor alpha (TNF-α), IL-10, and chemokines IL-8, Regulated on Activation, Normal T cell Expressed and Secreted (RANTES), Monocyte Chemoattractant Protein-1 (MCP-1), Monokine induced by gamma interferon (MIG), Interferon gamma-induced protein-10 (IP-10) e Transforming Growing Factor-beta (TGF-b) in the serum will be analyzed by Cytometric bead array (CBA) technique (BD Biosciences, San Jose, California, EUA). | Before and after 3 months of intervention | 
| Analysis of cortisol in the serum | The level plasmatic of cortisol hormone will be quantified by fluoroimmunoassay by AutoDelfia (Turku, Finland). | Before and after 3 months of intervention | 
| Level of physical activity | The level of Physical activity will be analyzed using a pedometer Yamax model PW 610 (Yamasa, Japan) during 7 consecutive days. | Before and after 3 months of intervention, and after 3 months of follow up | 
| Clinical Control | Clinical control will be evaluated by asthma control questionnaire (ACQ) | Before and after 3 months os intervention, ans after 3 months of follow up | 
| Health related quality of life | Health related quality of life will be assessed by Asthma Quality Life Questionnaire (AQLQ) | Before and after 3 months os intervention, and after 3 months of follow up | 
| Level of depression and anxiety | The symptoms of depression and anxiety will be assessed by Hospital Anxiety and Depression (HAD) | Before and after 3 months os intervention, and after 3 months of follow up | 
| Lung function | Lung volumes will be assessed by Spirometry | Before and after 3 months os intervention, and after 3 months of follow up | 
| Physical capacity | Maximal aerobic capacity (VO2max) will be assessed by Cardiopulmonary exercise test | Before and after 3 months os intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Asthma, Continuous Exercise Training, interval Exercise Training, Clinical Control, Inflammation