NCT06557824

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?

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
415

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 7, 2022

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2023

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 11, 2023

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

July 13, 2024

Completed
1 month until next milestone

First Posted

Study publicly available on registry

August 16, 2024

Completed
Last Updated

August 16, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

July 13, 2024

Last Update Submit

August 13, 2024

Conditions

Keywords

asthmachildrensubterranean therapy6MWTexhaled nitric oxide

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    January 2022 and October 2023

Secondary Outcomes (1)

  • Fractional exhaled nitric oxide concentration (FeNO)

    January 2022 and October 2023

Interventions

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.

Eligibility Criteria

Age3 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Patients with incomplete data

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Physical Education in Krakow

Krakow, 31-571, Poland

Location

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Sylwia Mętel, PhD

    University of Physical Education in Krakow

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD, MSc, working as Assistant Professor in Insitute of Applied Sciences, Faculty of Motor Rehabilitation, University of Physical Education in Krakow

Study Record Dates

First Submitted

July 13, 2024

First Posted

August 16, 2024

Study Start

January 7, 2022

Primary Completion

October 10, 2023

Study Completion

October 11, 2023

Last Updated

August 16, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Open access journals

Locations