Breathing Versus Aerobic Exercises on Asthma Control

Asthma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02065258
• Other study ID #: Breathing vs. aerobic exercise
• Secondary ID: 2009538179
• Status: Recruiting
• Phase: N/A
• First received: February 3, 2014
• Last updated: February 14, 2014
• Start date: February 2013
• Est. completion date: June 2014

Study information

• Verified date: December 2013
• Source: University of Sao Paulo General Hospital
• Contact: Celso Carvalho, PhD
• Phone: +55 11 30697451
• Email: cscarval[@]usp.br
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: June 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

Inclusion Criteria:

• Asthma moderate and severe

• Asthma will diagnosed (Global Initiative for Asthma -GINA)

• Body Mass Index <35 kg/ m2

• Sedentary

• Medical treatment, for at least 6 months

• Clinically stable

Exclusion Criteria:

• Smokers

• Cardiac disease

• Chronic Obstructive Pulmonary Disease

• Active Cancer

• Pregnant

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

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
• 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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	Sao Paulo	SP

Sponsors (3)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital	Fundação de Amparo à Pesquisa do Estado de São Paulo, University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change from Thoracoabdominal kinematics	Thoracoabdominal kinematics will be evaluated by using optoelectronic plethysmography (OEP system, BTS, Italy) as previously described Aliverti et al, 2006.	After 3 months of intervention	No
Other	Change from Heart rate variability	Heart rate variability will be assessed using heart rate variability (HRV) by a hert rate monitor ( Polar S810i, Finland) previously validated (Gamelin, Berthoin & Bosquet, 2006).	After 3 months of interventions	No
Other	Change from Airway and systemic inflammation	Airway inflammation will be quantified using the induced sputum , exhaled fraction of nitric oxide . Systemic inflammation will be evaluated by level of plasmatic inflammatory mediators Th1 ( IL-6, TNF) , Th2 (IL-4, IL-5 and IL-13) and anti-inflammatory ( IL-10 and IL-1ra)	After 3 months of interventions	No
Primary	Change from Clinical Control	Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)	After 3 months of intervetion	Yes
Secondary	Change from psychosocial morbidity	The psychosocial morbidity will be quantified by health factors related to quality of life (Asthma quality of life questionnaire- AQLQ) and depression and anxiety levels (HAD score)	After 3 months of intervetion	Yes
Secondary	Change from Daily life physical activity (DLPA)	Daily life physical activity will be assessed using an accelerometer (power Walker SW 610, Japan) that records the total daily number of steps and those performed at moderate intensity ( >110 steps per minute)	After 3 months of intervetion	Yes