- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT07935473
Effects of "Exercise Snack" in Individuals With Obesity (OBEXSNACK)
Effects of "Exercise Snack" on Physical Fitness,Vbody Composition, Enjoyment and Quality of Life in Outpatients With Obesity
Obesity is associated with reduced physical fitness, functional limitations, and poorer quality of life (Kell et al., 2001). Nutritional support and supervised exercise can improve weight management and physical health, but low motivation and perceived lack of time often limit participation to physical activity (Alberga et al., 2013; Baillot et al., 2021). Evidence shows that shorter-time exercise strategies may help overcome these barriers and support training adherence (Poon et al., 2020). Brief activity bouts distributed throughout the day, including vigorous intermittent lifestyle physical activity and structured "exercise snacks," may help to improve cardiorespiratory fitness, muscle function, and metabolic health (Islam et al., 2022; Ahmadi et al., 2024; Wang et al., 2024). Observational evidence also links VILPA to lower mortality risk (Stamatakis et al., 2023). Combining brief exercise bouts with education to interrupt prolonged sitting may therefore address both insufficient physical activity and sedentary behaviour (Dunstan et al., 2021; Dogra et al., 2022; Pinto et al., 2023). Generally, research has largely focused on healthy, inactive adults, with limited evidence in people with overweight or obesity (Jones et al., 2024). Rafiei et al. (2021) reported acute improvements in insulin and non-esterified fatty acid responses following brief stair-climbing bouts compared with prolonged sitting in adults with obesity. Schmidt et al. (2001) found comparable improvements in body composition and aerobic fitness following accumulated or continuous exercise during caloric restriction. The effects of exercise snacks combined with education to reduce sedentary behaviour nevertheless remain unclear. This study aims to evaluate the effects of an exercise-snacking programme on body composition, physical fitness, quality of life, and exercise adherence in adults with obesity.
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: Luca Cavaggioni, PhD
- Numéro de téléphone: +3902619111
- E-mail: cavaggioni.luca@gmail.com
Lieux d'étude
-
-
Mi
-
Milan, Mi, Italie, 20145
- Recrutement
- Istituto Auxologico Italiano IRCCS
-
Contact:
- Luca Cavaggioni, PhD
- Numéro de téléphone: 3485408103
- E-mail: cavaggioni.luca@gmail.com
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Male or female gender
- Body Mass Index more than 30 kg/m2
- Participation in physical activity fewer than twice per week
- informed consent signature
Exclusion Criteria:
- aged more than 70 years
- history of disabling musculoskeletal or osteoarticular conditions that prevent regular participation in physical activity, with a pain score > of 7 out of 10 arbitrary units on the visual analogue scale (VAS)
- history of hip or knee replacement
- Surgery within the 6 months preceding the study
- presence of severe hip or knee osteoarthrosis
- presence of cardiac, neurological or psychiatric disordes
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Expérimental: Exercise Snack Group
Exercise snacks activity throughout the day |
10-week-home-based training protocol to improve cardiorespiratory fitness, muscular strength and stability performed through a short bout of physical activity called "exercise snack". The programme consists of high-intensity home-based exercises performed in five 2-minute bouts per day, spaced 2 hours apart, for 7 days (10 minutes of exercise per day). |
|
Expérimental: Traditional Fitness Group
Conventional circuit training exercise |
10-week-home-based training protocol to improve cardiorespiratory fitness, muscular strength and stability performed through a circuit-training mode. The programme consists of home-based exercises performed in a circuit-training format (time of work per set 20 s, time of rest between each exercise 10 s, time of rest between sets 2 min, total volume 3 sets) for a duration of 35 min with a frequency of 3 days per week while performing traditional strength and postural control exercises. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline fat mass at ten weeks
Délai: up to ten weeks
|
Fat mass percentage measurement using a bioelectric impedance analysis |
up to ten weeks
|
|
Change from baseline fat free mass at ten weeks
Délai: up to ten weeks
|
Fat free mass percentage measurement using a bioelectric impedance analysis |
up to ten weeks
|
|
Change from baseline waist circumference at ten weeks
Délai: up to ten weeks
|
Waist circumference using a 200 centimeters tape measure in centimeters |
up to ten weeks
|
|
Change from baseline weight at ten weeks
Délai: up to ten weeks
|
Body weight using a calibrated weight scale in kilograms |
up to ten weeks
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline body balance at ten weeks
Délai: up to ten weeks
|
Body stability using the modified version of the Balance Error Scoring System protocol in arbitrary units with a 0-30 point scale in which lower scores mean a better outcome |
up to ten weeks
|
|
Change from baseline upper-body muscular strength at ten weeks
Délai: up to ten weeks
|
Maximal isometric grip strength in kilograms using the handgrip dynamometer |
up to ten weeks
|
|
Change from baseline lower-body muscular strength at six weeks
Délai: up to ten weeks
|
Amount of time in seconds during a chair raise using the Five Repetition Sit-To-Stand protocol |
up to ten weeks
|
|
Change from baseline cardiorespiratory fitness at ten weeks
Délai: up to ten weeks
|
Heart rate monitor in beats per minute during a 45-second squat exercise using the Ruffier-Dickson squat test protocol |
up to ten weeks
|
|
Change from baseline amount of physical activity at ten weeks
Délai: up to ten weeks
|
Weekly amount of physical activity and sedentary time using the short-form International Physical Activity Questionnaire expressed in mets per week |
up to ten weeks
|
|
Change from baseline enjoyment at ten weeks
Délai: up to ten weeks
|
Exercise enjoyment using the short-form PACES scale questionnaire in arbitrary units with a 0-5 point scale in which higher scores mean a better outcome |
up to ten weeks
|
|
Change from baseline adherence at ten weeks
Délai: up to ten weeks
|
Exercise enjoyment using the Exercise Adherence Rating Scale questionnaire in arbitrary units with a 0-5 point scale in which higher scores mean a better outcome |
up to ten weeks
|
|
Change from baseline quality of life perception at ten weeks
Délai: up to ten weeks
|
Subjective quality of life perception using the using the EuroQol EQ-5D VAS in arbitrary units with a 0-100 point scale in which higher scores mean a better outcome |
up to ten weeks
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Luca Cavaggioni, PhD, Istituto Auxologico Italiano IRCCS
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
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 43C504
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 .