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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04486989
Other study ID # 1R15DC017014-01A1
Secondary ID 0819.1s-ETSU
Status Completed
Phase N/A
First received
Last updated
Start date February 4, 2020
Est. completion date June 6, 2023

Study information

Verified date November 2023
Source East Tennessee State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Teachers are a population at high risk for voice disorders given their occupational demands. In a teaching career, a common debilitating symptom among all vocal symptoms experienced is - vocal fatigue, impacting teachers' occupational performance and increasing health care costs. It is therefore essential to identify potential treatment options to alleviate the symptom of vocal fatigue. The purpose of this study is to utilize a body-system level cardiovascular training protocol in comparison to traditional voice production training to alleviate the symptoms of vocal fatigue.


Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date June 6, 2023
Est. primary completion date March 30, 2023
Accepts healthy volunteers No
Gender Female
Age group 21 Years to 60 Years
Eligibility Inclusion Criteria: - Female teachers between the ages of 21-60 years Female instructors and college professors between the ages of 21-60 years - A score of = 15 on factor 1 of the VFI (tiredness and avoidance of voice use) or a score of = 5 on factor 3 of the VFI (improvement of symptoms or lack thereof with rest) - Sedentary- wherein participants will need to be completing mild intensity cardiovascular exercise less than 150 minutes in less than 5 days per week Exclusion Criteria: - Trained athletes - Trained singers - Smoking in the past 6months - Prior history of a vocal fold pathology and current vocal fold pathology

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Cardiovascular Conditioning Protocol
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
Other:
Voice Production Exercises
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.

Locations

Country Name City State
United States East Tennessee State University Johnson City Tennessee

Sponsors (1)

Lead Sponsor Collaborator
East Tennessee State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Changes in Physiologic Cost of Speaking Physiologic Cost of Speaking is measured as the rate of oxygen consumption at steady state/ rate of speech (wpm) for each of the two reading tasks At baseline, at 4 weeks after treatment
Primary Changes in Oxygen Uptake Kinetics Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks At baseline, at 4 weeks after treatment
Primary Changes in Post Task Physiological Recovery Post Task Physiological Recovery is measured as the time, seconds, to reach baseline of oxygen consumption post task (within 0.2ml/kg/min) following each of the reading tasks At baseline, at 4 weeks after treatment
Primary Changes in Excess Post Exercise Consumption (EPOC) EPOC is measured as the magnitude of recovery oxygen consumption, ml/kg/min for each of the reading tasks At baseline, at 4 weeks after treatment
Primary Changes in Ratings of Perceived Exertion (RPE) Borg Scale of Ratings of Perceived Exertion (RPE)- measures the self-report of vocal effort for each of the reading tasks At baseline, at 4 weeks after treatment
Primary Changes in Vocal Fatigue Index (VFI) Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue At baseline, at 4 weeks after treatment
Primary Changes in Global Rating of Vocal Fatigue (VAS 100mm) Global Rating of Vocal Fatigue (VAS 100mm) measures the ability to sustain voice with no fatigue at the end of a working day At baseline, at 4 weeks after treatment
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