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L'essai clinique NCT07044843 pour BPCO est actif, pas en recrutement. Consultez la vue en carte du Radar des Essais Cliniques et les outils de découverte par IA pour tous les détails, ou posez vos questions ici. | ||
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Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?
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L'étude clinique NCT07044843 est un essai interventionnel pour BPCO. Son statut actuel est : actif, pas en recrutement. L'étude a débuté le 23 juillet 2025 et vise à recruter 54 participants. Dirigé par Eastern Switzerland University of Applied Sciences, l'essai devrait être terminé d'ici le 31 décembre 2025. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 7 août 2025.
Résumé succinct
The aim of the current study is the effect of SSOT during a 3-weeks inpatient pulmonary rehabilitation program. Further aim is to analyze exercise endurance, distinguishing between those exercising whilst breathing air at 760m "normoxia", breathing air at approx. 1600m "hypoxia", or breathing SSOT at 760m "hyperoxia" conditions during inpatient pulmonary rehabilitation.
The objective of the study is to provide long-awaited data concerning the use of SSOT during training. To date, it is not clear whether patients with chronic lung diseases who reveal a SpO2 > 88% at rest but desaturate during exercise and thus may not qualify for long-term oxygen therapy undergoing PR benefit from supplemental oxygen.
Titre officiel
Oxygen Therapy During Exercise Training in Inpatient Rehabilitation in Chronic Lung Disease- Does it Matter?
Conditions
BPCOAutres identifiants de l'essai
- inRehaExO2_normoxia_hyperoxia
Numéro NCT
Date de début (réel)
2025-07-23
Dernière mise à jour publiée
2025-08-07
Date de fin (estimée)
2025-12-31
Inscription (estimée)
54
Type d'essai
Interventionnel
PHASE
N/A
Statut
Actif, pas en recrutement
Mots clés
Oxygen
Exercise
Rehabilitation
Exercise
Rehabilitation
Objectif principal
Traitement
Plan d'attribution
Randomisé
Modèle d'intervention
Séquentiel
Masquage
Quadruple aveugle
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
Comparateur facticeNormoxia Sham air (ambient air) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula. | Standard Ambiant Air Will Be Breathed During Endurance Training. ambiant air |
Comparateur actifHyperoxia Standardized supplemental oxygen therapy (SSOT) (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training | Oxygène SSOT and sham air (5l/min) will be applied with the oxygen concentrator EverFloTM via nasal cannula during training |
ExpérimentalHypoxia This group will train at moderate altitude. | Standard Ambiant Air Will Be Breathed During Endurance Training. ambiant air |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia | from baseline to 3 weeks |
| Critères d'évaluation | Description de critères | Période |
|---|---|---|
6 minute walk test (6MWT) | 6 minute walk distance (6MWD), SpO2 and heart rate at the end of the 6 minute walk test (6MWT) from baseline to 3 weeks at normoxia vs hypoxia vs hyperoxia | 3 weeks |
Hospital Anxiety and Depression Scale (HADS) normoxia vs hypoxia vs hyperoxia | HADS-A (Anxiety): 7 items
HADS-D (Depression): 7 items
Each item is scored from 0 to 3, resulting in:
Minimum score per subscale: 0
Maximum score per subscale: 21
Interpretation:
Higher scores indicate worse psychological status.
Scores of 0-7: Normal
Scores of 8-10: Borderline abnormal
Scores of 11-21: Abnormal (clinically relevant anxiety or depression) | 3 weeks |
mMRC score at normoxia vs hypoxia vs hyperoxia | The scale ranges from 0 to 4.
Each grade reflects a different level of functional limitation due to dyspnea.
Minimum score: 0 Maximum score: 4
Interpretation:
Higher scores indicate more severe dyspnea (worse outcome). | 3 weeks |
CAT score (COPD assessments tool) normoxia vs hypoxia vs hyperoxia | It consists of 8 items, each scored from 0 to 5.
The total score ranges from:
Minimum score: 0 Maximum score: 40
Interpretation:
Higher scores indicate greater symptom burden and worse health status.
Score bands for interpretation:
0-10: Low impact
11-20: Medium impact
21-30: High impact
31-40: Very high impact | 3 weeks |
Chronic respiratory questionnaire (CRQ) normoxia vs hypoxia vs hyperoxia | The CRQ consists of 20 items across four domains:
Dyspnea (5 items)
Fatigue (4 items)
Emotional function (7 items)
Mastery (4 items)
Each item is scored on a 7-point Likert scale:
Minimum score per item: 1
Maximum score per item: 7
Interpretation:
Higher scores indicate better health-related quality of life (less impairment).
Mean scores are calculated per domain and as a total score. | 3 weeks |
Change in cycling CWRET time normoxia vs hypoxia vs hyperoxia | 3 months |
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous
- aged ≥ 18 years
- stable condition > 3 weeks (e.g. no exacerbations)
- resting SpO2 ≥ 88% and exercise induced hypoxemia defined by a fall in SpO2 by ≥ 4% and/or below 90% during a 6-minute walk test (6MWT)
- informed consent as documented by signature.
- Severe daytime resting hypoxemia (SpO2 < 88%)
- long-term oxygen therapy
- unstable condition requiring adaptation of pharmacologic and other treatment modalities or requirement of intensive care or relevant severe concomitant disease
- inability to follow the procedures of the study, e.g. due to language problems psychological disorders, neurological or orthopedic problems with walking disability or inability to ride a bicycle
- women who are pregnant or breast feeding
- enrolment in another clinical trial with active treatment.
Eastern Switzerland University of Applied Sciences- National Center of Cardiology and Internal Medicine named after academician M.Mirrakhimov
- Université de Zurich267 essais cliniques actifs à explorer
Aucune donnée de contact disponible
2 Centres de l'essai dans 2 pays
Canton of St. Gallen
Eastern Switzerland University of Applied Sciences, Sankt Gallen, Canton of St. Gallen, 9001, Switzerland
National center for cardiology and internal medicine, Bishkek, Kyrgyzstan