Assessing Visual Feedback of HR Monitoring in Rehabilitation - Pilot
Assessing Feasibility, Efficacy, and Acceptability of Visual Feedback During HR Monitoring in Rehabilitation
Panoramica dello studio
Stato
Descrizione dettagliata
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.
Tipo di studio
Iscrizione (Anticipato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Miriam Rafferty, DPT, PhD
- Numero di telefono: 312-238-7233
- Email: mrafferty@sralab.org
Backup dei contatti dello studio
- Nome: Kristen Hohl, DPT
- Email: khohl@sralab.org
Luoghi di studio
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Illinois
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Chicago, Illinois, Stati Uniti, 60611
- Reclutamento
- Shirley Ryan AbilityLab
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Contatto:
- Miriam Rafferty, DPT, PhD
- Email: mrafferty@sralab.org
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Contatto:
- Kristen Hohl, DPT
- Numero di telefono: 3122381378
- Email: khohl@sralab.org
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Ricerca sui servizi sanitari
- Assegnazione: Non randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
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Nessun intervento: 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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Comparatore attivo: 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.
Altri nomi:
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Sperimentale: 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.
Altri nomi:
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Heart Rate
Lasso di tempo: 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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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Clinician Behavior
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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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Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Miriam Rafferty, DPT, PhD, Shirley Ryan AbilityLab
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Inizio studio (Anticipato)
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- STU00216223
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Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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