J45
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: • Clinically diagnosed bronchial asthma (ICD: J45) • Age 4–6 years • Regularly scheduled four-week inpatient rehabilitation stay • Written consent from the parents
Exclusion criteria
Exclusion criteria: • Acute asthma exacerbation • Unstable asthma (e.g., recurrent dyspnea, increased need for rescue medication) • General condition with reduced exercise tolerance or clinical impairment • Severe chronic comorbidities with contraindications to thermal stimuli • Decompensated cardiorespiratory diseases • Allergic or bronchospastic reactions to medicinal plants or essential oils used • Lack of medical clearance due to medical uncertainty
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoints for the second work package (WP2) are the feasibility of implementing a Kneipp-based hydrotherapeutic intervention plan in a rehabilitation clinic, as well as adherence (fidelity) and reach. Adherence (fidelity) is defined as the proportion of measures actually performed relative to the individually planned measures according to the therapy plan. Reach is defined as the proportion of those included in the study out of those who meet the inclusion criteria and are invited to participate. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary or exploratory clinical endpoints (indications of efficacy) include, first, the feasibility of the intervention, which is assessed through a brief structured descriptive interview using a Likert scale. This captures acceptance (perception of the Kneipp concept as satisfactory), adaptability (the extent to which Kneipp interventions can be tailored or refined to individual needs), compatibility (parents’ and staff’s assessment of successful implementation in the rehab setting or at home), and complexity (perception of the comprehensibility/applicability of the intervention and related information as well as the number of intervention components). Second, health-related quality of life is measured using PAQLQ, PACQLQ, Pictorial PAQLQ, and KINDL; third, asthma-specific symptoms are measured using C-ACT as well as the frequency of asthma exacerbations; fourth, respiratory infections or cold symptoms are assessed using CARIFS, CCQ (Common Cold Questionnaire), and NCI CTC-AE scales (gastroenterological endpoints). Additionally, the context and culture of applying Kneipp interventions in the rehab setting are captured through staff (telephone interviews), sustainability among staff and parents (the extent to which an intervention continues to be carried out) is described, and the self-efficacy expectations of parents and therapists in the context of a Kneipp water intervention are recorded immediately before the start (T0) and after completion (T2). | — |
Countries
Germany
Contacts
Institut für Umweltmedizin und Integrative Gesundheit