- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05241171
The "Step4Life" Randomized Control Trial in Hemodialysis
The Impact of Use of a Wearable Pedometer and Structured Feedback Program on Physical Activity in Hemodialysis Patients: The "Step4Life" Randomized Control Trial
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
Physical activity is an important modifiable behavior that is known to impact morbidity and mortality. The patients with advance kidney disease especially those on chronic hemodialysis are deconditioned with decreased muscle mass, and have co-morbidities such as anemia, malnutrition, and depression. These factors may explain why hemodialysis patients are known to have very low physical activity relative to healthy populations. We have recently demonstrated that hemodialysis patients are frequently sedentary, walk less with lower levels of physical activity. Thus, this provides an opportunity to design interventions to improve and sustain physical activity levels in hemodialysis patients.
There is a growing experience of digital technology and intervention delivery modalities to promote physical activity in chronic comorbid conditions, but little is known in hemodialysis patients. We set forward to test a weekly coaching intervention guided by a wearable pedometer to determine whether it would be feasible, promote physical activity, and be sustained for 12 weeks in hemodialysis patients. Equipped with pedometer data, informing subjects quantitatively about their levels of physical activity relative to other hemodialysis patients, might promote physical activity in this high-risk population.
We conduct a 12-week, open label, randomized controlled trial to determine the feasibility and effectiveness of providing structured feedback instruction (e.g., behavioral feedback, goal setting) along with a wearable pedometer (FitBit ®) in sustaining or improving physical activity levels in chronic hemodialysis patients as compared to the wearable pedometer (automated self-managed) alone. I hypothesized that the structured feedback intervention coupled with the wearable pedometer would be feasible, would improve physical activity, and would be sustainable for 12 weeks in hemodialysis patients.
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
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California
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San Diego, California, États-Unis, 92101
- University of California San Diego
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion Criteria:
1) HD for ≥3 months, 2) age ≥18 years, and 3) ability to walk with or without assistive devices,
Exclusion Criteria:
1) wheelchair bound, 2) unstable severe health conditions (e.g., acute infections, heart failure (HF) NYHA class 4 and/or unstable angina), 3) hospitalization within 3 months before enrollment for non-access related reasons, or 4) clinically recognized cognitive impairment including dementia or psychosis.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Autre
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Expérimental: Fitbit plus Feedback Intervention
Participants who were randomized to the provider-feedback intervention arm received goal setting, and feedback graphs and charts,
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The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
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Comparateur actif: Fitbit alone
Participants in self-managed control group were provided access to the Fitbit website or app but did not receive any feedback on their activity level from the study team.
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The study participants in intervention group received feedback based on steps achieved every week (converted to average steps per day) after randomization.
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
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the absolute change from baseline in step counts per week from baseline to 12-weeks between randomized groups.
Délai: 12 weeks
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weekly step counts measured with Fitbit
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12 weeks
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Rakesh Malhotra, MD, MPH, University of California, San Diego
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
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
- P171917
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
produit fabriqué et exporté des États-Unis.
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 .
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