Pulmonary Rehabilitation Combined With Speleotherapy in Children With Bronchial Asthma

Completed

• Conditions: Asthma in Children

• Registration Number: NCT06557824
• Lead Sponsor: University School of Physical Education, Krakow, Poland

Brief 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 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 Timeline

• Study Start: 2022-01-07
• Primary Completion: 2023-10-10
• Study Completion: 2023-10-11
• Study First Submitted: 2024-07-13
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-13
• Last Update Submitted: 2024-08-13
• Study First Posted: 2024-08-16
• Last Update Posted: 2024-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 415

Inclusion Criteria

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

Exclusion Criteria

• Patients with incomplete data

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Forced expiratory flow in 1 second	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)	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])	January 2022 and October 2023	Peak expiratory flow (PEFR \[pp\]) to assess the pulmonary function in children with asthma before and after speleotherapeutic intervention.

Secondary Outcome Measures

Name	Time	Method
Fractional exhaled nitric oxide concentration (FeNO)	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.

Trial Locations

Locations (1)

University of Physical Education in Krakow; 🇵🇱 Krakow, Poland