Trials / Unknown
UnknownNCT02065258
Breathing Versus Aerobic Exercises on Asthma Control
Comparison Between Breathing and Aerobic Exercises on Clinical Control, Psychosocial Morbidity, Thoracoabdominal Kinematics, and Airway Inflammation in Patients With Moderate-to-severe Asthma: a Randomized Trial
- Status
- Unknown
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- University of Sao Paulo General Hospital · Academic / Other
- Sex
- All
- Age
- 25 Years – 65 Years
- Healthy volunteers
- Not accepted
Summary
Background: Asthma is a chronic inflammatory airway disease characterized by reversible obstruction, inflammation and hyperresponsiveness to different stimulus. Aerobic and breathing exercises have been demonstrated to benefit asthmatic patients; however, there is no evidence comparing the effectiveness of the treatments. Objective: To compare the effects of aerobic and breathing exercises on clinical control (primary outcome), psychosocial morbidity and daily life physical activity (secondary outcome) in patients with moderate-to-severe persistent asthma. In addition, thoracoabdominal kinematics, heart rate variability and airway and systemic inflammation will be evaluated. The initial hypothesis will be that both exercises present improved clinical control of asthma. Methods: Forty-eight asthmatic adults will be randomly divided into 2 groups: aerobic (AG) and breathing exercises (BG). All treatments will be performed twice a week for 3 months, totalizing 24 sessions of 40 minutes each. Both groups will complete an educational program consisting of 2 classes at the beginning of the interventions. Before and after interventions, the following parameters will be quantified: clinical control, health related quality of life, levels of anxiety and depression, maximal exercise capacity, autonomic nervous imbalance, daily living physical activity, thoracoabdominal kinematics, inflammatory cells in the sputum, fraction of exhaled nitric oxide (FENO) and systemic inflammatory cytokines. Asthma symptoms will be quantified monthly using diaries. Kolmogorov-Smirnov test will be used to analyze the data normality, and a two-way ANOVA with repeated measures with appropriate post hoc test (Student Newman Keuls) will be used to compare the inter and intra-groups differences
Detailed description
Both groups completed an educational program that consisted of two classes held once a week, each lasting 2 hours. Presentations and group discussions were done, including information about asthma pathophysiology, medication skills, self-monitoring techniques, and environmental control and avoidance strategies.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Breathing exercise | It will be based on Yoga´s breathing technique (Eliade, 1996) and will be focus on to stimulate nasal and diaphragmatic breathings, to increase expiratory time, to slow respiratory flow and to regulate the breathing rhythm. Breathing exercises will be divided into 3 phases (lasting one month each) with progressive intensity every 8 sessions. All participants will be required to maintain their normal medical regimens during the interventions. Will be part of the routine of breathing exercises the following exercises: I) Kapalabhati, II) Uddhiyana |
| OTHER | Aerobic exercise | Exercise will be performed on a treadmill (Imbramed Export Plus, Brazil) with the initial intensity of 60% of the maximum predicted heart rate for patient´s age (Tanaka et al, 2001) reaching a maximal of 80% during the training. The intensity values will be calculated using Karvonen's formule (1957). Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. Before and after every session, patients will perform a peak expiratory flow test and if values were lower than 70% of the patient´s maximum value, they will be advised to use the rescue dose of bronchodilator prescribed the their physician |
Timeline
- Start date
- 2013-02-01
- Primary completion
- 2014-02-01
- Completion
- 2014-06-01
- First posted
- 2014-02-17
- Last updated
- 2014-02-17
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT02065258. Inclusion in this directory is not an endorsement.