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
2 other identifiers
interventional
48
1 country
1
Brief 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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable asthma
Started Feb 2013
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2014
CompletedFirst Submitted
Initial submission to the registry
February 3, 2014
CompletedFirst Posted
Study publicly available on registry
February 17, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2014
CompletedFebruary 17, 2014
December 1, 2013
1 year
February 3, 2014
February 14, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from Clinical Control
Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)
After 3 months of intervetion
Secondary Outcomes (2)
Change from psychosocial morbidity
After 3 months of intervetion
Change from Daily life physical activity (DLPA)
After 3 months of intervetion
Other Outcomes (3)
Change from Thoracoabdominal kinematics
After 3 months of intervention
Change from Heart rate variability
After 3 months of interventions
Change from Airway and systemic inflammation
After 3 months of interventions
Study Arms (2)
Breathing Exercise
ACTIVE COMPARATORIt 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 and will be part of the routine of breathing exercises the following exercises: I) Kapalabhati ; II) Uddhiyana ;III) Surya Bedhana
Aerobic Exercise
ACTIVE COMPARATORExercise will be performed on a treadmill, 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).Aerobic training sessions that will consist in 40 minutes divided in 5 minutes of warm-up, 35 minutes of aerobic training and 5 minutes of cool down. Exercise intensity will be increased if the patient do not present any increase in asthma symptoms during the exercise for 2 consecutive training days. The program will be performed twice a week, for 3 months.
Interventions
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
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Smokers
- Cardiac disease
- Chronic Obstructive Pulmonary Disease
- Active Cancer
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05360-160, Brazil
Related Publications (2)
Evaristo KB, Mendes FAR, Saccomani MG, Cukier A, Carvalho-Pinto RM, Rodrigues MR, Santaella DF, Saraiva-Romanholo BM, Martins MA, Carvalho CRF. Effects of Aerobic Training Versus Breathing Exercises on Asthma Control: A Randomized Trial. J Allergy Clin Immunol Pract. 2020 Oct;8(9):2989-2996.e4. doi: 10.1016/j.jaip.2020.06.042. Epub 2020 Aug 6.
PMID: 32773365DERIVEDEvaristo KB, Saccomani MG, Martins MA, Cukier A, Stelmach R, Rodrigues MR, Santaella DF, Carvalho CR. Comparison between breathing and aerobic exercise on clinical control in patients with moderate-to-severe asthma: protocol of a randomized trial. BMC Pulm Med. 2014 Oct 17;14:160. doi: 10.1186/1471-2466-14-160.
PMID: 25326140DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Celso RF Carvalho, PT, PhD
University of Sao Paulo General Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 3, 2014
First Posted
February 17, 2014
Study Start
February 1, 2013
Primary Completion
February 1, 2014
Study Completion
June 1, 2014
Last Updated
February 17, 2014
Record last verified: 2013-12