- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07837375
SPARK: Supporting Physical Activity Through Reality-Augmented Knowledge in COPD (SPARK)
Acceptability of an Augmented Reality Virtual Coach for Physical Exercise Practice in Patients With Chronic Obstructive Pulmonary Disease: a Multicenter Study
Chronic obstructive pulmonary disease (COPD) is associated with dyspnea, reduced physical activity, muscle deconditioning, and impaired quality of life. Pulmonary rehabilitation is an effective non-pharmacological intervention, but access remains limited and long-term adherence to physical exercise is often difficult to maintain. Augmented reality may provide an innovative approach to support exercise practice by offering real-time visual and auditory guidance while allowing patients to remain anchored in their real environment.
The SPARK study is a multicenter, interventional, non-randomized, proof-of-concept study designed to assess the acceptability of an augmented reality virtual coach for physical exercise in adults with COPD. Participants will attend a single experimental session including baseline questionnaires, presentation of the augmented reality headset, a short immersive exercise session guided by a virtual coach, and post-immersion assessments. Acceptability will be evaluated using the Technology Acceptance Model 3 questionnaire before and after immersion. User experience will also be explored through focus group discussions analyzed according to UXive dimensions.
The study aims to determine whether this technology is acceptable to patients with COPD and to identify factors that may facilitate or limit its future integration into pulmonary rehabilitation pathways.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Angélique Picard
- E-mail: Angelique.picard@ch-havre.fr
Sauvegarde des contacts de l'étude
- Nom: Clement Medrinal, PhD
- Numéro de téléphone: +33664615110
- E-mail: clement.medrinal@ch-havre.fr
Lieux d'étude
-
-
-
Montivilliers, France, 76290
- Recrutement
- Groupe Hospitalier du Havre
-
Contact:
- Clément Medrinal
- Numéro de téléphone: 0664615110
- E-mail: clement.medrinal@ch-havre.fr
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Age ≥ 18 years Diagnosis of chronic obstructive pulmonary disease (COPD) confirmed according to GOLD recommendations, defined by a post-bronchodilator FEV1/FVC ratio < 0.70 No exacerbation during the previous month, defined as hospitalization or major therapeutic modification related to worsening respiratory symptoms Written informed consent obtained before any study-related procedure Affiliation to a social security system
Exclusion Criteria:
- COPD exacerbation during the previous month Major motor disorders, disabling osteoarticular conditions, or significant functional dependence preventing safe participation in physical exercises Insufficient cognitive or language abilities to understand instructions, complete questionnaires, or participate in the semi-structured interview Photosensitive epilepsy Uncorrected or atypical visual and/or hearing impairment Patient under legal guardianship, curatorship, or incarcerated Pregnant or breastfeeding woman
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: N / A
- Modèle interventionnel: Affectation à un seul groupe
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Augmented Reality Virtual Coach Session
Participants with chronic obstructive pulmonary disease will attend a single experimental session using an augmented reality headset with a virtual coach. After baseline questionnaires and headset presentation, participants will complete an approximately 20-minute guided exercise session including calf raises, sit-to-stand exercises, and stretching. The virtual coach provides standardized instructions and corrective feedback during strengthening exercises. Acceptability will be assessed before and after immersion using the TAM3 questionnaire, followed by a focus group exploring user experience. |
Participants will use an augmented reality headset delivering a virtual coach-guided exercise session. The intervention consists of a single approximately 20-minute immersive session performed in a secured environment. The virtual coach provides standardized instructions and corrective feedback during strengthening exercises. The session includes calf raises, sit-to-stand exercises, and stretching. The intervention is designed to assess the acceptability and user experience of an augmented reality-based exercise support tool in adults with chronic obstructive pulmonary disease.
Autres noms:
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Global Acceptability Score of the Augmented Reality Virtual Coach
Délai: Immediately after the augmented reality immersion session, during the single study visit
|
Acceptability will be assessed using the global score of the adapted Technology Acceptance Model 3 questionnaire completed immediately after the augmented reality immersion session. Items are rated on a 7-point Likert scale, with higher scores indicating greater acceptability. The mean global score will be compared with the theoretical neutral value of 4. |
Immediately after the augmented reality immersion session, during the single study visit
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: Anaick Perrochon, PhD, Université Limoges
- Directeur d'études: Bonnevie Tristan, PhD, ADIR Association
- Directeur d'études: Benoit Borel, PhD, Université Limoges
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Estimé)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 2026-A00566-45
- 2026-A00566-45 (Identificateur de registre: ANSM)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .