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L'essai clinique NCT06859528 pour Maladie de Parkinson, Parkinson Disease, Idiopathic est 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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Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease 40
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT06859528 est une étude interventionnel pour Maladie de Parkinson, Parkinson Disease, Idiopathic. Son statut actuel est : en recrutement. L'étude a débuté le 1 avril 2025 et vise à recruter 40 participants. Dirigée par l'Université de Saint-Louis, l'étude devrait être terminée d'ici le 30 septembre 2027. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 14 mai 2025.
Résumé succinct
This study will investigate the feasibility of a 6-month community walking program for people with Parkinson's disease (PD) and their care partners in greater Saint Louis, Missouri region. The walking program will consist of weekly, organized walking groups at the Missouri Botanical Gardens. Participants in the program will use Nordic walking poles during the walks. The walking group(s) will meet once per week and wi...Afficher plus
Titre officiel
Step Up to PD: A Community-based Walking Program for People With Parkinson's Disease
Pathologies
Maladie de ParkinsonParkinson Disease, IdiopathicAutres identifiants de l'étude
- 34235
Numéro NCT
Date de début (réel)
2025-04-01
Dernière mise à jour publiée
2025-05-14
Date de fin (estimée)
2027-09-30
Inscription (estimée)
40
Type d'étude
Interventionnel
PHASE
N/A
Statut
En recrutement
Mots clés
Walking
Physical Activity
Social Connectedness
Loneliness
Physical Activity
Social Connectedness
Loneliness
Objectif principal
Traitement
Méthode d'allocation
N/A
Modèle d'intervention
Groupe unique
Masquage
Aucun (ouvert)
Bras / Interventions
| Groupe de participants/Bras | Intervention/Traitement |
|---|---|
ExpérimentalAttend group community walking program for 60 minutes each week Participants will participate in one, 60-minute group walk using Nordic poles at the Missouri Botanical Gardens for at least 6 months, with an optional continuation upto 12 months. Participants will be assessed before the program begins, after 6-months, and after 12 months. Falls will be prospectively collected for 6 months following completion of the program. | Community Walking Program This is a group, community walking program at local parks using Nordic walking poles. Participants will be encouraged to walk briskly but safely for 60 minutes one time per week with the ultimate goal of using this community walking program to drive behavioral change (increased physical and social engagement in their communities) throughout the week. |
Critère principal d'évaluation
Critère secondaire d'évaluation
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Safety/Rate of Falls - Feasibility | The rate falls related to walking program participation. | From enrollment to both the 6 and 12 month endpoints |
Enrollment - Feasibility | The percentage of eligible participants that enroll in the study. | Through enrollment of all the study participants |
Attendance - Feasibility | The percentage of attended walking program session across all enrolled participants. | Enrollment through the 6- and 12-month endpoints |
| Critères d'évaluation | Description de la mesure | Période |
|---|---|---|
Steps per Day | This outcome will be captured via wearable sensors worn through the duration of study participation. | From baseline assessment through the the end of the fall reporting period at 18 months |
Balance Discordance | This is the difference between actual balance confidence (captured via the activities specific balance confidence scale) and predicted balance confidence (modeled from time to complete the Timed Up and Go Test). | From baseline assessment through the 6- and 12-month endpoints |
Loneliness | Assessed with the 20 item UCLA loneliness scale in which subjects rate the degree of loneliness that they experience in daily life. The scale has a minimum score of 20 and maximum score of 80 with higher scores indicating that the individual is experience more loneliness. | From baseline assessment through the 6- and 12-month endpoints |
Social Connection | Assessed with the Berkman-Syme Social Network Index, an 11-item questionnaire in which participants rate their perceived social network and isolation. The index has a minimum score of zero and maximum score of 11 with higher score indicating a larger and stronger social network. | From baseline assessment through the 6- and 12-month endpoints |
Assistant à la participation
Critères d'éligibilité
Âges éligibles
Adulte, Adulte âgé
Âge minimum
30 Years
Sexes éligibles
Tous
- 30-85 years old
- Neurologist-diagnosed Parkinson's disease
- Able to walk independently with or without a walking aid (e.g., cane, walker)
- Willing to participate in study for at least 6 months
- Health diagnosis that would limit exercise participation (e.g., heart problems, uncontrolled blood pressure, exercise-induced asthma).
- Additional neurologic disease or injury beyond Parkinson's disease.
- Evidence of significant cognitive impairment. This will be determined by completing the Montreal Cognitive Assessment
- Participants with poor walking ability (determined using the Timed Up and Go Test during initial testing).
Partie responsable de l'étude
Jason Longhurst, Investigateur principal, Assistant Professor, St. Louis University
Contact central de l'étude
Contact: Jason K Longhurst, DPT, PHD, 314-977-8533, [email protected]
1 Centres de l'étude dans 1 pays
Missouri
Integrated Health and Movement Science Laboratory, Saint Louis University, St Louis, Missouri, 63104, United States
En recrutement