AsthmaNCT03392129
Ai Chi Method for Children With Asthma
A study testing Ai Chi 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 Ai Chi 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, Respiratory Disease
- What is being tested?
- Ai Chi and Asthma education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Dec 2017to 20 Jul 2020
- 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), obesity, 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, 1 recruiting
- Recruiting
Universidade Federal do Rio Grande do Norte (UFRN)
Natal, Rio Grande do Norte, 59078-970
Karla Mendonça, Phd, +55 84 3342-2020, karla-morganna@hotmail.com
Renata Tomaz, Phd, +55 83 999351535, renatinha_sud@hotmail.com
About this study
Official title: Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
This study has the aim to assess the effectiveness of the Ai Chi 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 diagnosis will be included. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma, based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2017.Children in the intervention group will perform 12 sessions (twice a week) of treatment with the Ai Chi Method and educational interventions similiar to the control group. The investigators will assess pulmonary function (spirometry), asthma control by the Childhood Asthma Control Test (c-ACT Questionnaire), quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), anxiety symptoms by the SCAS (Spence Children's Anxiety Scale) and Disturbed Sleep by the Sleep Disorders Scale in Children. 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, Respiratory Disease, Hydrotherapy, Respiratory Tract Diseases, Respiratory Hypersensitivity
- Being tested
- Ai Chi, Asthma education
- Keywords
- Asthma, Child, respiratory exercises, Hydrotherapy, Physical Therapy Specialty, Sleep, Quality of life, Anxiety, Spirometry, Clinical trial
- Medical subject headings
- Asthma, Respiration Disorders, Respiratory Tract Diseases, Respiratory Hypersensitivity, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ai ChiOther
Children in the intervention group will perform 12 sessions (twice a week 40 minutes each session) of treatment with the Ai Chi Method, and educational intervention in relation to asthma.
Asthma educationOther
Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma.
| Study group | Role | What they receive |
|---|---|---|
| Ai Chi | Experimental | Children in the intervention group will perform 12 sessions (twice a week, 40 minutes each session) of treatment with the Ai Chi Method and educational interventions in relation to asthma. Receives: Other: Ai Chi |
| 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 Lung function (spirometry).
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow between 25-75% of the pulmonary volume (FEF25-75).
Measured: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Secondary outcomes (4)
Change in asthma control.
Asthma control will be assessed by the Childhood Asthma Control Test - c-ACT Questionnaire Mean c-ACT score. Do higher values of 19 points represent a better outcome .
Measured: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Quality of life
Quality of life of childhood asthma as assessed by the Standardized Pediatric Asthma Quality of Life Questionnaire (PAQLQ). 7 point rating scale Do higher values represent a better outcome.
Measured: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Anxiety symptoms.
Change in Spence Children's Anxiety Scale following intervention. Self-reported (child and parent version) child anxiety symptoms, 38 items questionnaire, rated at a 4-point scale. Do higher values represent a worse outcome.
Measured: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Disturbed Sleep.
Disturbed Sleep will be assessed by the Sleep Disorders Scale in Children. 26 items questionnaire, rated at a 5-point scale. Do higher values represent a worse outcome.
Measured: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start20 Dec 2017
- Primary completion20 Jul 2020 (estimated)
- Study completion20 Jul 2020 (estimated)
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
- 42 participants (estimated)
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
- Investigators
- Karla Mendonça, PT, PhD, Principal investigator, Universidade Federal do Rio Grande do NorteRenata Tomaz, PT, PhD's Student, Principal investigator, Universidade Federal do Rio Grande do NorteAda Jácome, PT, PhD's student, Principal investigator, Universidade Federal do Rio Grande do NorteThayla Amorim, PT, Ms, Principal investigator, Universidade Federal do Rio Grande do Norte
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03392129
- Sponsor's protocol ID
- 67253617.4.0000.5537
- Status last verified
- Aug 2019
- First submitted
- 28 Dec 2017
- Last updated
- 12 Aug 2019
- Results posted
- No
- Data monitoring committee
- 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 12 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ai Chi Method for Children With Asthma: A Single-blinded Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03392129
- Acronym / sponsor ID
- 67253617.4.0000.5537
- Conditions
- Asthma, Child, Respiratory Disease, Hydrotherapy, Respiratory Tract Diseases, Respiratory Hypersensitivity
- Keywords
- Asthma, Child, respiratory exercises, Hydrotherapy, Physical Therapy Specialty, Sleep, Quality of life, Anxiety
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 42 participants (estimated)
- Lead sponsor
- Universidade Federal do Rio Grande do NorteUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 20 Jul 2020 (estimated)
- Study completion
- 20 Jul 2020 (estimated)
- First posted
- 5 Jan 2018 (actual)
- 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 Ai Chi method as an adjunct therapy in the treatment of children with asthma.
Detailed description
Children from 7 to 12 years old with asthma diagnosis will be included. Children assigned to the control group will receive, along with their parents, educational interventions in relation to asthma, based on guidelines of Global Strategy for Asthma Management and Prevention Revised 2017.Children in the intervention group will perform 12 sessions (twice a week) of treatment with the Ai Chi Method and educational interventions similiar to the control group. The investigators will assess pulmonary function (spirometry), asthma control by the Childhood Asthma Control Test (c-ACT Questionnaire), quality of life by the PAQLQ (Paediatric Asthma Quality of Life Questionnaire), anxiety symptoms by the SCAS (Spence Children's Anxiety Scale) and Disturbed Sleep by the Sleep Disorders Scale in Children. 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 |
|---|---|---|
| Ai Chi | Experimental | Other: Ai ChiChildren in the intervention group will perform 12 sessions (twice a week, 40 minutes each session) of treatment with the Ai Chi Method and educational interventions in relation to asthma. |
| 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), obesity, 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 |
|---|---|---|
| Ai ChiChildren in the intervention group will perform 12 sessions (twice a week 40 minutes each session) of treatment with the Ai Chi Method, and educational intervention in relation to asthma. | Other | Ai Chi |
| Asthma educationChildren assigned to the control group will receive, along with their parents, educational interventions in relation to asthma. | Other | Asthma education |
Primary outcome
Change in Lung function (spirometry).
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Forced expiratory volume in one second (FEV1), forced vital capacity (FVC), FEV1/FVC ratio, forced expiratory flow between 25-75% of the pulmonary volume (FEF25-75).
4 secondary outcomes
Change in asthma control.
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Quality of life
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Anxiety symptoms.
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Change in Disturbed Sleep.
Time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Asthma
Enrolling by invitationObservational study
Allergy, Asthma, and Atopic Eczema in Finland
Asthma, Asthma in Children
RecruitingPhase 2
Rademikibart IV for Acute Asthma and COPD Exacerbation
Asthma Acute, COPD Exacerbation Acute
Active, not recruiting
Community Health Equity Accelerator (CHEA) Pediatric Asthma Intervention
Asthma in Children
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
RecruitingObservational study
NHALES (Natural History of Asthma With Longitudinal Environmental Sampling)
Asthma
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.
Karla Mendonça, PT, PhD principal investigator
Universidade Federal do Rio Grande do Norte
Renata Tomaz, PT, PhD's Student principal investigator
Universidade Federal do Rio Grande do Norte
Ada Jácome, PT, PhD's student principal investigator
Universidade Federal do Rio Grande do Norte
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ai Chi 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: status not confirmed, as of the sponsor's last update on 12 Aug 2019. 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 Karla Morganna P.P Mendonça, PT, PHD (+55 84 3342-2020, karla-morganna@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Lung function (spirometry). (time frame: Baseline, six weeks later (endpoint) and one month since the initial of intervention (follow-up)). 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 12 Aug 2019.