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Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot

1 mars 2022 mis à jour par: Miriam Rafferty, Shirley Ryan AbilityLab

Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation

Monitoring heart rate during exercise can provide feedback to the patient and provider that the patient is exercising in the appropriate, individualized and safe range for them. This is particularly important in a group setting when multiple individuals are supervised by one provider. This study is interested in assessing the difference in intensity of care delivered when visual feedback of heart rate is provided vs. no visual feedback of heart rate in rehabilitation. Visual feedback of heart rate will be provided through Heart Zones, a platform which synthesizes multiple signals from externally worn heart rate monitors. This study is interested in better understanding the acceptability, feasibility and appropriateness of this technology when used in rehabilitation.

Aperçu de l'étude

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

Interventionnel

Inscription (Anticipé)

90

Phase

  • N'est pas applicable

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Coordonnées de l'étude

Sauvegarde des contacts de l'étude

Lieux d'étude

    • Illinois
      • Chicago, Illinois, États-Unis, 60611
        • Recrutement
        • Shirley Ryan AbilityLab
        • Contact:
        • Contact:

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 90 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

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

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

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
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.
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.
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:
  • Heart Zones, Inc
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.
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:
  • Heart Zones, Inc

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)
Average Mean HR, average time in target zone
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)

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Clinician Behavior
Délai: Up to 6 months
Number of times HR, RPE, or intensity is monitored and/or modified based on feedback during rehabilitation sessions
Up to 6 months
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)
monitoring for adverse events
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)
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)
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.
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)

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Les enquêteurs

  • Chercheur principal: Miriam Rafferty, DPT, PhD, Shirley Ryan AbilityLab

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude (Anticipé)

1 mars 2022

Achèvement primaire (Anticipé)

1 décembre 2022

Achèvement de l'étude (Anticipé)

1 décembre 2022

Dates d'inscription aux études

Première soumission

1 février 2022

Première soumission répondant aux critères de contrôle qualité

1 mars 2022

Première publication (Réel)

10 mars 2022

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

10 mars 2022

Dernière mise à jour soumise répondant aux critères de contrôle qualité

1 mars 2022

Dernière vérification

1 mars 2022

Plus d'information

Termes liés à cette étude

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) ?

NON

Description du régime IPD

Pilot data of individuals clinical care with plan for future work to validate process.

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

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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