Asthma in ChildrenNCT06557824
Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma
An observational study of Asthma in Children, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
Trial summary
The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was: Does speleotherapeutic intervention increase distance in… Read more about this study
- Who is it for?
- Ages 3 to 18 years
- Conditions the study is for
- Asthma in Children
- What is being tested?
- speleotherapeutic intervention
- How many people
- 415 participants
- Where
- 1 sitePoland
- Study dates
- 7 Jan 2022to 11 Oct 2023
- Phase
- Observational
- 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 3 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed.
Who may be able to join
- Children with asthma who partcipated in speleotherapeutic intervention in Sanatorium Edel in Zlate Hory
Who cannot join
- Patients with incomplete data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma: a Retrospective Study.
The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was:
- Does speleotherapeutic intervention increase distance in 6-Minute Walk Test (6MWT) and influence spirometry parameters and fractional exhaled nitric oxide concentration (FeNO) in children with asthma?
Read the detailed description
Background: Bronchial asthma is the leading cause of chronic disease and missed school days in children. The aim of the study was to evaluate pulmonary function and exercise tolerance in children with asthma who underwent speleotherapeutic intervention (STI) between January 2022 and October 2023 at Sanatorium Edel in Zlaté Hory.
Methods: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed. The patients attended rehabilitation and treatment stays with a median length of 32 days combined with an average number of 15 speleotherapy sessions. The spirometry parameters, fractional exhaled nitric oxide concentration (FeNO), and 6-Minute Walk Test (6MWT) distance were measured before and after STI.
- Conditions
- Asthma in Children
- Being tested
- speleotherapeutic intervention
- Keywords
- asthma, children, subterranean therapy, 6MWT, exhaled nitric oxide
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
speleotherapeutic interventionOther
In the study, medical records of 415 Czech children diagnosed with bronchial asthma who took part in speleotherapeutic intervention between January 2022 and October 2023 were analysed.
What is being measured
The primary outcome is the main question the study is designed to answer.
Forced expiratory flow in 1 second
Forced expiratory flow in 1 second, pp=percent predicted (FEV1 [pp]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention.
Measured: January 2022 and October 2023
6-Minute Walk Test (6MWT)
6-Minute Walk Test (6MWT) distance was measured to assess exercise tolerance in children with asthma before and after speleotherapeutic intervention.
Measured: January 2022 and October 2023
Peak expiratory flow (PEFR [pp])
Peak expiratory flow (PEFR [pp]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention.
Measured: January 2022 and October 2023
Secondary outcomes (1)
Fractional exhaled nitric oxide concentration (FeNO)
The fractional exhaled nitric oxide concentration (FeNO) was measured to recognize the presence of eosinophillic inflammation involving the bronchial tree in children with asthma before and after speleotherapeutic intervention.
Measured: January 2022 and October 2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2024
- Study start7 Jan 2022
- Primary completion10 Oct 2023
- Study completion11 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Asthma in ChildrenStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Retrospective
- Enrolment
- 415 participants (actual)
Sponsor and investigators
- Lead sponsor
- University School of Physical Education, Krakow, Poland
- Sponsor type
- University, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University, Sanatorium Edel, Health Resort "Wieliczka" Salt Mine
- Responsible party
- Principal investigator, Sylwia Mętel, University School of Physical Education, Krakow, Poland
- Investigators
- Sylwia Mętel, PhD, Principal investigator, University of Physical Education in Krakow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06557824
- Sponsor's protocol ID
- AWF-EDEL 1/2024
- Status last verified
- Aug 2024
- First submitted
- 13 Jul 2024
- Last updated
- 16 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Open access journals
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma: a Retrospective Study.
- ClinicalTrials.gov ID
- NCT06557824
- Acronym / sponsor ID
- AWF-EDEL 1/2024
- Conditions
- Asthma in Children
- Keywords
- asthma, children, subterranean therapy, 6MWT, exhaled nitric oxide
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 415 participants (actual)
- Lead sponsor
- University School of Physical Education, Krakow, PolandUniversity, hospital or other
- Collaborators
- Andrzej Frycz Modrzewski Krakow University, Sanatorium Edel, Health Resort "Wieliczka" Salt Mine
- Study start
- 7 Jan 2022 (actual)
- Primary completion
- 10 Oct 2023 (actual)
- Study completion
- 11 Oct 2023 (actual)
- First posted
- 16 Aug 2024 (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.
The goal of this retrospective study is to learn about the effects of rehabilitation and treatment stays combined with speleotherapy in children with asthma. Medical records of 415 patients with this clinical diagnosis were analyzed and the main question was:
- Does speleotherapeutic intervention increase distance in 6-Minute Walk Test (6MWT) and influence spirometry parameters and fractional exhaled nitric oxide concentration (FeNO) in children with asthma?
Detailed description
Background: Bronchial asthma is the leading cause of chronic disease and missed school days in children. The aim of the study was to evaluate pulmonary function and exercise tolerance in children with asthma who underwent speleotherapeutic intervention (STI) between January 2022 and October 2023 at Sanatorium Edel in Zlaté Hory.
Methods: Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed. The patients attended rehabilitation and treatment stays with a median length of 32 days combined with an average number of 15 speleotherapy sessions. The spirometry parameters, fractional exhaled nitric oxide concentration (FeNO), and 6-Minute Walk Test (6MWT) distance were measured before and after STI.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 3 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed.
Key inclusion criteria (1 listed)
- Children with asthma who partcipated in speleotherapeutic intervention in Sanatorium Edel in Zlate Hory
Key exclusion criteria (1 listed)
- Patients with incomplete data
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 |
|---|---|---|
| speleotherapeutic interventionIn the study, medical records of 415 Czech children diagnosed with bronchial asthma who took part in speleotherapeutic intervention between January 2022 and October 2023 were analysed. | Other | – |
Primary outcome
Forced expiratory flow in 1 second
Time frame: January 2022 and October 2023
Forced expiratory flow in 1 second, pp=percent predicted (FEV1 [pp]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention.
6-Minute Walk Test (6MWT)
Time frame: January 2022 and October 2023
6-Minute Walk Test (6MWT) distance was measured to assess exercise tolerance in children with asthma before and after speleotherapeutic intervention.
Peak expiratory flow (PEFR [pp])
Time frame: January 2022 and October 2023
Peak expiratory flow (PEFR [pp]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention.
1 secondary outcome
Fractional exhaled nitric oxide concentration (FeNO)
Time frame: January 2022 and October 2023
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 16 Aug 2024.
- Individual participant dataSharing planned: No. Open access journals
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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.
Sylwia Mętel, PhD principal investigator
University of Physical Education in Krakow
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma in Children, run by University School of Physical Education, Krakow, Poland at 1 site in Poland.
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 1 inclusion and 1 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 16 Aug 2024. 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 Poland. 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?
Forced expiratory flow in 1 second (time frame: January 2022 and October 2023). The study lists 3 primary outcomes in all. 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 16 Aug 2024.