Clinical trial NCT03015870: Technology-assisted Vocal Exercise for Older Adults
Official title: Technology-assisted Vocal Exercise for Older Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Aging
Keywords: vocal dysfunction
voice
vocal folds
vocal aging
Lead sponsor: University of Illinois at Urbana-Champaign
Sponsor class: OTHER
First posted: 2017-01-10
Enrollment: 26
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Vocal acoustic function
timeFrame: 8-week change from baseline
measure: Vocal aerodynamic function
timeFrame: 8-week change from baseline
Secondary outcomes:
measure: Program engagement and app usability
timeFrame: 8-week training period
measure: Training-induced Change in Voice-related Quality of Life
timeFrame: 8-week change from baseline
measure: Acceptability/feasibility of intervention
timeFrame: Post-intervention (8-week follow-up)
measure: Respiratory Function
timeFrame: 8-week change from baseline
Other outcomes:
Locations:
city: Champaign
country: United States
facility: University of Illinois at Urbana-Champaign
state: Illinois
Study officials:
affiliation: University of Illinois at Urbana-Champaign
name: Aaron M Johnson, PhD
role: PRINCIPAL_INVESTIGATOR
References: