AsthmaNCT02065258
Breathing Versus Aerobic Exercises on Asthma Control
A study testing Breathing exercise and Aerobic exercise in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 25 to 65 years
- Conditions the study is for
- Asthma
- What is being tested?
- Breathing exercise and Aerobic exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteBrazil
- Study dates
- Feb 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Smokers
- Cardiac disease
- Chronic Obstructive Pulmonary Disease
- Active Cancer
- Pregnant
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital das Clínicas da FMUSP
São Paulo, São Paulo, 05360-160
Celso RF Carvalho, PhD
Milene G Saccomani, Msc
About this study
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
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
Read the 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
- Asthma
- Being tested
- Breathing exercise, Aerobic exercise
- Keywords
- Asthma, Clinical control, Exercise
- Medical subject headings
- Asthma, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Breathing exerciseOther
Also called Yoga
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 exerciseOther
Also called Aerobic training
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
| Study group | Role | What they receive |
|---|---|---|
| Breathing Exercise | Active comparator | 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 and will be part of the routine of breathing exercises the following exercises: I) Kapalabhati ; II) Uddhiyana ;III) Surya Bedhana Receives: Other: Breathing exercise |
| Aerobic Exercise | Active comparator | Exercise 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. Receives: Other: Aerobic exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Clinical Control
Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)
Measured: After 3 months of intervetion
Secondary outcomes (2)
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)
Measured: After 3 months of intervetion
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)
Measured: After 3 months of intervetion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2014 (estimated)
- Study startFeb 2013
- Primary completionFeb 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AsthmaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Responsible party
- Sponsor
- Investigators
- Celso RF Carvalho, PT, PhD, Principal investigator, University of Sao Paulo General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02065258
- Sponsor's protocol ID
- Breathing vs. aerobic exercise
- Other IDs
- 2009538179
- Status last verified
- Dec 2013
- First submitted
- 3 Feb 2014
- Last updated
- 17 Feb 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 32773365Evaristo 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.
PubMed 25326140
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02065258
- Acronym / sponsor ID
- Breathing vs. aerobic exercise
- Conditions
- Asthma
- Keywords
- Asthma, Clinical control, Exercise
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- University of Sao Paulo General HospitalUniversity, hospital or other
- Collaborators
- University of Sao Paulo, Fundação de Amparo à Pesquisa do Estado de São Paulo
- Study start
- Feb 2013
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 17 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Breathing Exercise | Active comparator | Other: Breathing exerciseIt 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 comparator | Other: Aerobic exerciseExercise 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. |
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- Smokers
- Cardiac disease
- Chronic Obstructive Pulmonary Disease
- Active Cancer
- Pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Breathing exerciseAlso: YogaIt 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 | Breathing Exercise |
| Aerobic exerciseAlso: Aerobic trainingExercise 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 | Other | Aerobic Exercise |
Primary outcome
Change from Clinical Control
Time frame: After 3 months of intervetion
Clinical control will be evaluated by Asthma Control Questionnaire (ACQ)
2 secondary outcomes
Change from psychosocial morbidity
Time frame: After 3 months of intervetion
Change from Daily life physical activity (DLPA)
Time frame: After 3 months of intervetion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2014.
- Derived from this study: PubMed 32773365Evaristo 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.
- Derived from this study: PubMed 25326140Evaristo 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Celso RF Carvalho, PT, PhD principal investigator
University of Sao Paulo General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breathing exercise and Aerobic exercise in people with Asthma, run by University of Sao Paulo General Hospital at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Feb 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Celso Carvalho, PhD (+55 11 30697451, cscarval@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Clinical Control (time frame: After 3 months of intervetion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02065258, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2014.