AsthmaNCT02720380
Buteyko Method for Children With Asthma
A study testing Buteyko and Asthma education in people with Asthma and Child, run by Universidade Federal do Rio Grande do Norte at 1 site in Brazil.
Trial summary
This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma. Read more about this study
- Who is it for?
- Ages 7 to 12 years
- Conditions the study is for
- Asthma, Child, Breathing Exercises
- What is being tested?
- Buteyko and Asthma education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBrazil
- Study dates
- Jul 2015to May 2016
- 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 7 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Children from 7 up to 12 years old with asthma diagnose;
- Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
- Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
Who cannot join
- Children that are not able to perform some of the necessary procedures;
- Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Universidade Federal do Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59078970
About this study
Official title: Buteyko Method for Children With Asthma: a Randomized Controlled Trial
This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.
Read the detailed description
Children from 7 to 12 years old with asthma diagnose will be included. Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. The investigators will assess quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen peripheral saturation will also be assessed during the tests. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage .
- Conditions
- Asthma, Child, Breathing Exercises
- Being tested
- Buteyko, Asthma education
- Keywords
- Asthma, Physical Therapy Specialty, Breathing Exercises, Child, Clinical Trail
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ButeykoOther
Intervention will be held twice a week during 3 weeks.
Asthma educationOther
Educational interventions in relation to asthma will be given to children assigned to the control group.
| Study group | Role | What they receive |
|---|---|---|
| Buteyko | Experimental | Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Receives: Other: Buteyko |
| Asthma education | Active comparator | Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. Receives: Other: Asthma education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Quality of life (questionnaire)
Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).
Measured: Baseline and three weeks later
Secondary outcomes (6)
Change in pulmonary function (spirometry)
Measured parameters (which will be expressed as percent predicted): FVC, FEV1, FEV1/FVC, FEF25-75%, PEF. PEF will be expressed as L/min.
Measured: Baseline and three weeks later
Change in the Six-minute walk test distance
Measured: Baseline and three weeks later
Number of visits to the emergency room
Measured: Through study completion, an average of three weeks
Occurrence of absences in school
Measured: Through study completion, an average of three weeks
Occurrence of exacerbations
Occurrence of asthma exacerbations or allergy episodes
Measured: Through study completion, an average of three weeks
Occurrence of Beta2-agonists usage
Measured: Through study completion, an average of three weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJul 2015
- Primary completionMay 2016
- Study completionMay 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidade Federal do Rio Grande do Norte
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karla Morganna Pereira Pinto de Mendonça, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02720380
- Sponsor's protocol ID
- 562.554
- Status last verified
- Jan 2017
- First submitted
- 7 Mar 2016
- Last updated
- 24 Jan 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Buteyko Method for Children With Asthma: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02720380
- Acronym / sponsor ID
- 562.554
- Conditions
- Asthma, Child, Breathing Exercises
- Keywords
- Asthma, Physical Therapy Specialty, Breathing Exercises, Child, Clinical Trail
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 25 Mar 2016 (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.
This study has the aim to assess the effectiveness of the Buteyko method as an adjunct therapy in the treatment of children with asthma.
Detailed description
Children from 7 to 12 years old with asthma diagnose will be included. Children in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. The investigators will assess quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), pulmonary function (spirometry) and the six-minute walk test. Vital signs, pulmonary auscultation and oxygen peripheral saturation will also be assessed during the tests. In addition, information will be collected on the numbers of hospitalizations, occurence of absence in school due to exacerbation of the disease, asthma symptoms and Beta2-agonists usage .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Buteyko | Experimental | Other: ButeykoChildren in the intervention group will perform 6 sessions (twice a week) of treatment with the Buteyko Method. |
| Asthma education | Active comparator | Other: Asthma educationChildren assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. |
Who may qualify
- Ages
- 7 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Children from 7 up to 12 years old with asthma diagnose;
- Regular inhaled corticosteroids with no change in dose in the preceding 4 weeks;
- Children cannot present: other respiratory disease (such as cystic fibrosis, bronchiectasis, tuberculosis), retinal detachment, hypertensive crisis, congenital heart defect, pulmonary edema, history of lobectomy or lung segmentectomy, respiratory infections 15 days prior to the evaluations.
Key exclusion criteria (2 listed)
- Children that are not able to perform some of the necessary procedures;
- Give up participating in the research and present acute symptoms of respiratory tract during the assessments.
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 |
|---|---|---|
| ButeykoIntervention will be held twice a week during 3 weeks. | Other | Buteyko |
| Asthma educationEducational interventions in relation to asthma will be given to children assigned to the control group. | Other | Asthma education |
Primary outcome
Change in Quality of life (questionnaire)
Time frame: Baseline and three weeks later
Quality of life will be assessed by the Pediatric Asthma Quality of Life Questionnaire (PAQLQ).
6 secondary outcomes
Change in pulmonary function (spirometry)
Time frame: Baseline and three weeks later
Change in the Six-minute walk test distance
Time frame: Baseline and three weeks later
Number of visits to the emergency room
Time frame: Through study completion, an average of three weeks
Occurrence of absences in school
Time frame: Through study completion, an average of three weeks
Occurrence of exacerbations
Time frame: Through study completion, an average of three weeks
Occurrence of Beta2-agonists usage
Time frame: Through study completion, an average of three weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2017.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Buteyko and Asthma education in people with Asthma and Child, run by Universidade Federal do Rio Grande do Norte 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 3 inclusion and 2 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: finished, as of the sponsor's last update on 24 Jan 2017. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Quality of life (questionnaire) (time frame: Baseline and three weeks later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jan 2017; AzTrials last refreshed its copy on 27 Oct 2026.