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Technology-assisted Vocal Exercise for Older Adults

6. januar 2017 opdateret af: 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.

Studieoversigt

Detaljeret 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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

26

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

    • Illinois
      • Champaign, Illinois, Forenede Stater, 61820
        • University of Illinois at Urbana-Champaign

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

65 år og ældre (Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: 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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2014

Primær færdiggørelse (Faktiske)

1. december 2016

Studieafslutning (Faktiske)

1. december 2016

Datoer for studieregistrering

Først indsendt

4. november 2015

Først indsendt, der opfyldte QC-kriterier

6. januar 2017

Først opslået (Skøn)

10. januar 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

10. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

6. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • IRB15130

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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.

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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