- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05097885
Avantages pour la santé des vibrations globales du corps (VIBE-Rx)
Enquête pilote sur les bienfaits pour la santé de l'entraînement par vibrations subaiguës (12 semaines) sur tout le corps
The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking/running or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.
Type d'étude
Inscription (Estimé)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
Georgia
-
Augusta, Georgia, États-Unis, 30912
- Augusta University/Georgia Prevention Institute/ Laboratory of Integrative and Exercise Physiology
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
- Men and women (> 18 yrs old)
- All races
Exclusion Criteria:
- <18 years old
- Clinical diagnosis of hepatic, cardiovascular, or renal disease
- Diabetic complications (i.e. macrovascular, microvascular, or autonomic)
- Pregnancy
- Direct vasoactive medications (i.e. nitrates)
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: Sous-aiguë (12 semaines) Entraînement de tout le corps
|
Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and/or reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and/or reduce the duration of rest. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change in VO2 Peak
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline relative (mL/kg/min) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Flow-Mediated Dilation (FMD)
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline brachial artery flow mediated dilation at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Skeletal Muscle Mitochondrial Function
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline skeletal muscle mitochondrial function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1) |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Pulse Wave Velocity (PWV)
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m/s. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in Post Occlusive Reactive Hyperemia (PORH)
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI). |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
|
Change in IL-6
Délai: pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks. |
pre-treatment baseline and following 12 weeks sub-acute whole-body vibration
|
Collaborateurs et enquêteurs
Parrainer
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
Autres numéros d'identification d'étude
- 1818010
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 .