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Technology-assisted Vocal Exercise for Older Adults

6 de enero de 2017 actualizado por: University of Illinois at Urbana-Champaign
Many detrimental effects of aging have been identified in the human voice, most of which are accepted as "normal". However, age-related vocal deficits disrupt communication and decrease quality of life in older adults and may be preventable and/or treatable through behavioral interventions. The objective of this proposal is to determine the effectiveness of a technology-assisted vocal exercise intervention on the vocal function and quality of life in older adults. Forty older adults (65+) will be recruited and randomly assigned to either an app or PDF-delivered vocal training intervention lasting 8 weeks. Pre- and post-testing involving vocal functioning assessments, as well as mobility, psychosocial, and cognitive functioning assessments will be conducted. This interdisciplinary project will enhance the investigators understanding of physical, mental, and social health-related quality of life among older adults.

Descripción general del estudio

Descripción detallada

All participants will receive an iPad pre-loaded with an instructional PDF containing written instructions and embedded recorded audio prompts to assist with the delivery of an established vocal training paradigm, the Vocal Function Exercises (VFE) developed by Stemple.22 The VFE involves a set of four exercises focusing on extending maximum phonation time, increasing pitch range, and, therefore, improving coordination of the respiratory, phonatory, and resonatory systems during voicing. The iPads will be collected from the participants at the conclusion of the study at the post-intervention testing sessions.

Participants will be randomly assigned to either an experimental feedback group or active control no feedback group. Participants in the feedback group will receive iPads pre-loaded with Sonneta Voice Monitor app (MintLeaf Software) which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions. The no feedback group will be provided with an iPad pre-installed with the PDF for the full duration of the study, but no feedback app.

Prior to and separate from the individual baseline testing appointments (described below), one group-based introductory session will be held to orient all participants to iPad controls (i.e., navigation, volume, recordings), as well as training specific to their assigned condition (how to use the pdf or app). Participants will complete a progressive weekly training schedule (3, 4, 5, 6, 7, 7, 7, & 7 days per week) 2x per day for 30-minute sessions over 8 weeks. The first training session will be monitored to provide technical assistance and ensure fidelity of the training protocol. Undergraduate research assistants from Dr. Johnson's lab will contact each participant via telephone on a weekly basis to provide technical assistance and confirm adherence to the training schedule.

Tipo de estudio

Intervencionista

Inscripción (Actual)

26

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Illinois
      • Champaign, Illinois, Estados Unidos, 61820
        • University of Illinois at Urbana-Champaign

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

65 años y mayores (Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 65 years or older
  • Vision at least 20/40 with glass or contacts

Exclusion Criteria:

  • Moderate-severe cognitive impairment
  • Currently engaged in regular daily singing practice
  • Currently involved in a research study involving exercise, memory, or vocal strengthening
  • Currently being treated for a voice disorder by either an ENT or SLP

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Feedback
Behavioral: Vocal exercise with real-time feedback.
The feedback intervention will use iPads pre-installed with a PDF of vocal exercises for the full duration of the study and with an app which will provide tailored feedback regarding pitch, loudness, and duration of phonation during practice sessions.
Comparador activo: Recording
Behavioral: Vocal exercise with recording
The recording intervention will use an iPad pre-installed with the PDF of vocal exercises for the full duration of the study, but no feedback app.Participants audio record self while performing vocal exercises

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Vocal acoustic function
Periodo de tiempo: 8-week change from baseline
Dysphonia Severity Index: composite measure of maximum phonation time (s), highest fundamental frequency (Hz), lowest intensity (dB) and jitter (%).
8-week change from baseline
Vocal aerodynamic function
Periodo de tiempo: 8-week change from baseline
Phonation threshold pressure (kPa)
8-week change from baseline

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Program engagement and app usability
Periodo de tiempo: 8-week training period
Assessed via self-report (and verified via objective data) weekly during intervention and computed as an un-weighted composite score reflecting 8-week program adherence and ease of use.
8-week training period
Training-induced Change in Voice-related Quality of Life
Periodo de tiempo: 8-week change from baseline
The London Chest Activity of Daily Living Scale will be used to assess theoretical and mechanistic components of the vocal exercise intervention. Un-weight composite scores will be calculated at each assessment.
8-week change from baseline
Acceptability/feasibility of intervention
Periodo de tiempo: Post-intervention (8-week follow-up)
Self-reported level of agreement (1 strongly disagree, 7 strongly agree) with three separate statements ("I enjoyed the program I used to exercise my voice," "I will continue to use the training techniques in the future," and "I believe my voice improved as a result of my participation in this program")
Post-intervention (8-week follow-up)
Respiratory Function
Periodo de tiempo: 8-week change from baseline
FEV1 - forced expiratory volume in 1 second (Liters)
8-week change from baseline

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

  • Investigador principal: Aaron M Johnson, PhD, University of Illinois at Urbana-Champaign

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de septiembre de 2014

Finalización primaria (Actual)

1 de diciembre de 2016

Finalización del estudio (Actual)

1 de diciembre de 2016

Fechas de registro del estudio

Enviado por primera vez

4 de noviembre de 2015

Primero enviado que cumplió con los criterios de control de calidad

6 de enero de 2017

Publicado por primera vez (Estimar)

10 de enero de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

10 de enero de 2017

Última actualización enviada que cumplió con los criterios de control de calidad

6 de enero de 2017

Última verificación

1 de enero de 2017

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • IRB15130

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Descripción del plan IPD

Primary data will be made available via https://databank.illinois.edu/ within 6 months of trial completion. Secondary data will be available within 2 years of trial completion.

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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