- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02140086
Buteyko Based Remedial Breathing Therapy With Children With Asthma
March 1, 2016 updated by: ARCIM Institute Academic Research in Complementary and Integrative Medicine
A randomized, controlled trial to investigate the effects of a buteyko based remedial breathing therapy on children with asthma regarding to their symptoms, use of medication and lung function tests.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
32
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Baden-Württemberg
-
Filderstadt, Baden-Württemberg, Germany, 70794
- Filderklinik
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 15 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- signed informed consent of the parents
- age 6- 15 years
- information and consent of the consulting doctor
- levels of asthma therapy 1-3
Exclusion Criteria:
- participation in another study
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Buteyko based Remedial Breathing Therapy
|
Buteyko based remedial Breathing Therapy after Dr. Buteyko
|
|
No Intervention: Waiting List
Training in the course of the study
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Reduction of Betamimetics (-30%) at 3- and/or 6-month follow up
Time Frame: asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up
|
asthmaspezific parameters are measured before and after intervention as well as 3- and 6- month follow up
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Asthma Control Questionnaire (ACQ)
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
Scores of the ACQ (Asthma Control Questionnaire)
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
Paediatric Asthma Quality of Life Questionnaire (PAQLQ)
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
Scores of PAQLQ (Paediatric Asthma Quality of Life Questionnaire)
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
ARCIM Questionnaire (AFB)
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
Scores of the AFB (ARCIM Questionnaire) regarding to asthma symptoms of the last 3 month (AFB is not validated)
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
Peak Flow
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
|
NO-measurement nasal and oral
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
|
Buteyko-Questionnaire
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
|
parameters of spirometry
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
|
|
Paediatric asthma caregiver´s quality of life questionnaire (PACQLQ)
Time Frame: parameters are measured before and after intervention as well as 3- and 6- month follow up
|
parameters are measured before and after intervention as well as 3- and 6- month follow up
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2014
Primary Completion (Actual)
November 1, 2014
Study Completion (Actual)
November 1, 2014
Study Registration Dates
First Submitted
May 14, 2014
First Submitted That Met QC Criteria
May 15, 2014
First Posted (Estimate)
May 16, 2014
Study Record Updates
Last Update Posted (Estimate)
March 2, 2016
Last Update Submitted That Met QC Criteria
March 1, 2016
Last Verified
March 1, 2016
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- RBT_03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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