- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05273801
Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot
Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
Aperçu de l'étude
Statut
Les conditions
Description détaillée
OBJECTIVES:
The purpose of this investigation is to determine if knowledge of heart rate (HR) and target HR zones (HRzone), with visual feedback vs no feedback of HR or HRzone improves patient exercise intensity during rehabilitation. The central hypothesis for this study is with visual feedback of HR and target HR zones with instruction about exercise intensity and targets will increase patient HR intensity during sessions within a safe range set by their medical team. For purposes of this study, patients will be monitored in group and individuals sessions throughout the rehabilitation continuum of care sites including: inpatient rehabilitation, day rehabilitation, and community fitness and will be inclusive of all individuals with chronic health conditions. Physical activity and exercise guidelines recommend everyone, including those with chronic health conditions, strive for 150 minutes of moderate intensity aerobic exercise per week. This study will contribute to the knowledge of how patients achieve recommended individual HR and moderate-high intensity zones during exercise.
Aim 1: Measure the extent to which monitoring and education regarding intensity is provided (1) before HR monitoring intervention, (2) when providers know HR monitoring is occurring but without visual feedback for the group, and (3) with visual feedback of HR monitoring in a group setting.
The investigators hypothesize providers will modify their behavior in the number of times they ask about intensity, adjust session intensity or provide education regarding intensity when visual feedback is provided compared to no feedback, which will be further increased from pre-study baseline levels.
Aim 2: Determine the efficacy of using HR with visual feedback during rehabilitation to reach target intensity.
The investigators hypothesize participants will have higher mean HR and increased time in their individualized target HR zones when given visual feedback compared to no feedback during sessions.
Aim 3: Determine the safety of using Heart Zones technology in rehabilitation settings for increasing participant exercise intensity.
The investigators hypothesize the technology will be safe without an increase in number of adverse events throughout their rehabilitation stay.
Aim 4: Assess patient acceptability, exercise self-efficacy and confidence following use of Heart Zones technology in group settings.
The investigators hypothesize use of Heart Zones technology in rehabilitation with feedback will increase participant self-efficacy and confidence in reaching higher exercise intensities, and will be well accepted.
Type d'étude
Inscription (Anticipé)
Phase
- N'est pas applicable
Contacts et emplacements
Coordonnées de l'étude
- Nom: Miriam Rafferty, DPT, PhD
- Numéro de téléphone: 312-238-7233
- E-mail: mrafferty@sralab.org
Sauvegarde des contacts de l'étude
- Nom: Kristen Hohl, DPT
- E-mail: khohl@sralab.org
Lieux d'étude
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Recrutement
- Shirley Ryan AbilityLab
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Contact:
- Miriam Rafferty, DPT, PhD
- E-mail: mrafferty@sralab.org
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Contact:
- Kristen Hohl, DPT
- Numéro de téléphone: 3122381378
- E-mail: khohl@sralab.org
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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:
- Admitted to inpatient rehabilitation, day rehabilitation or participant in community fitness
- Qualifies for group therapy based on diagnosis and insurance reimbursement
- Physician clearance for participation
Exclusion Criteria:
- Unable to provide informed consent due to cognitive impairment
- Inability to communicate with investigators
- Sternal Precautions
- Individuals with LVADs
- Pregnant women
- Uncontrolled Hypertension
- Serious and unstable cardiac arrhythmias
- Loss of bilateral upper extremity sensation
- At high risk for skin breakdown due to poor skin integrity (open wound, fragile skin, etc)
- Previous participation in this study while in another level of care in the last 6 months
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Recherche sur les services de santé
- Répartition: Non randomisé
- Modèle interventionnel: Affectation croisée
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
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Aucune intervention: Clinician Arm (period 1) - behavior prior to HR intervention
The investigators will monitor baseline behavior of providers in regards to sessions and how frequently heart rate (HR), rating of perceived exertion (RPE) and intensity is monitored and subsequent sessions are performed/modified through observation.
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Comparateur actif: Clinician arm (period 2) & Patient arm (control - HR monitor, no feedback)
Participants will receive 1 week of HR monitoring in their group sessions where visual feedback is not provided during group session.
The investigators will monitor overall HR response, mean HR and time in target HR zone, RPE and clinician behavior to HR monitor on patient during these sessions.
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Heart rates are recorded from multiple participants during the group sessions.
However during this intervention, it will not be cast to a TV for feedback to the participant or clinician.
Autres noms:
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Expérimental: Clinician arm (period 3) & Patient arm (active - HR monitor, with feedback)
The same participants will receive 1 week of HR monitoring with visual feedback during group sessions.
The investigators will monitor overall HR response, mean time HR and time in target zone, RPE, and clinician behavior to HR monitoring with visual feedback.
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Visual feedback of HR is provided through a TV monitor.
Multiple heart rates can be displayed and recorded simultaneously allowing for group encouragement, continuous monitoring and adjustment of all participants to ensure reaching appropriate target intensity.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Heart Rate
Délai: During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)
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Average Mean HR, average time in target zone
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During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Clinician Behavior
Délai: Up to 6 months
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Number of times HR, RPE, or intensity is monitored and/or modified based on feedback during rehabilitation sessions
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Up to 6 months
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Incidence of Adverse Events
Délai: During therapy sessions (1-4 hours per day, up to 5 days per week) and through duration of patient's rehabilitation stay (approximately 10-90 days)
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monitoring for adverse events
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During therapy sessions (1-4 hours per day, up to 5 days per week) and through duration of patient's rehabilitation stay (approximately 10-90 days)
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Participant Self-Efficacy and Confidence
Délai: During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)
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Using a scale from 0-100%, participant's will rate their self-efficacy and confidence in their ability to achieve target exercise intensity and confidence in performing the activity without a heart rate monitor.
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During therapy sessions (1-4 hours per day, up to 5 days per week) through the duration of patient's rehabilitation stay (approximately 10-90 days)
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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Miriam Rafferty, DPT, PhD, Shirley Ryan AbilityLab
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Anticipé)
Achèvement primaire (Anticipé)
Achèvement de l'étude (Anticipé)
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
Autres numéros d'identification d'étude
- STU00216223
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime IPD
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
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