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Technology-assisted Vocal Exercise for Older Adults

6. januar 2017 oppdatert av: 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.

Studieoversikt

Detaljert beskrivelse

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.

Studietype

Intervensjonell

Registrering (Faktiske)

26

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • Illinois
      • Champaign, Illinois, Forente stater, 61820
        • University of Illinois at Urbana-Champaign

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

65 år og eldre (Eldre voksen)

Tar imot friske frivillige

Ja

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
Aktiv komparator: 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

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Vocal acoustic function
Tidsramme: 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
Tidsramme: 8-week change from baseline
Phonation threshold pressure (kPa)
8-week change from baseline

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Program engagement and app usability
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 8-week change from baseline
FEV1 - forced expiratory volume in 1 second (Liters)
8-week change from baseline

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

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

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2014

Primær fullføring (Faktiske)

1. desember 2016

Studiet fullført (Faktiske)

1. desember 2016

Datoer for studieregistrering

Først innsendt

4. november 2015

Først innsendt som oppfylte QC-kriteriene

6. januar 2017

Først lagt ut (Anslag)

10. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

10. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Andre studie-ID-numre

  • IRB15130

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

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.

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Abonnere