Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma

August 13, 2024 updated by: Sylwia Mętel, University School of Physical Education, Krakow, Poland

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?

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

415

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

  • Poland
      • Krakow, Poland, 31-571
        • University of Physical Education in Krakow

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

  • Child
  • Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Medical records of 415 patients with clinical diagnosis of bronchial asthma (J45.9, J45.0, J45, J45.8, J45.1) were analysed.

Description

Inclusion Criteria:

- Children with asthma who partcipated in speleotherapeutic intervention in Sanatorium Edel in Zlate Hory

Exclusion Criteria:

  • Patients with incomplete data

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
January 2022 and October 2023
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.
January 2022 and October 2023
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.
January 2022 and October 2023

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Fractional exhaled nitric oxide concentration (FeNO)
Time Frame: January 2022 and October 2023
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.
January 2022 and October 2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University School of Physical Education, Krakow, Poland

Collaborators

Andrzej Frycz Modrzewski Krakow University
Sanatorium Edel
Health Resort "Wieliczka" Salt Mine

Investigators

  • Principal Investigator: Sylwia Mętel, PhD, University of Physical Education in Krakow

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 (Actual)

January 7, 2022

Primary Completion (Actual)

October 10, 2023

Study Completion (Actual)

October 11, 2023

Study Registration Dates

First Submitted

July 13, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 16, 2024

Study Record Updates

Last Update Posted (Actual)

August 16, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AWF-EDEL 1/2024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Open access journals

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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