- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04486989
Treatment for Teachers With Vocal Fatigue
November 16, 2023 updated by: Chayadevie Nanjundeswaran, East Tennessee State University
Cardiovascular Conditioning in the Treatment of Vocal Fatigue
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
31
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Chaya Nanjundeswaran (Guntupalli), Ph.D.
- Phone Number: 423-439-4036
- Email: nanjundeswar@etsu.edu
Study Locations
-
-
Tennessee
-
Johnson City, Tennessee, United States, 37614
- East Tennessee State University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
21 years to 45 years (Adult)
Accepts Healthy Volunteers
No
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cardiovascular Conditioning Protocol
Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.
|
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
|
Active Comparator: Voice Production Exercises
Participants will complete voice production exercises twice per week for a period of 4 weeks.
|
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Changes in Physiologic Cost of Speaking
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Changes in Oxygen Uptake Kinetics
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Changes in Post Task Physiological Recovery
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Changes in Excess Post Exercise Consumption (EPOC)
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Changes in Ratings of Perceived Exertion (RPE)
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Changes in Vocal Fatigue Index (VFI)
Time Frame: At baseline, at 4 weeks after treatment
|
Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue
|
At baseline, at 4 weeks after treatment
|
Changes in Global Rating of Vocal Fatigue (VAS 100mm)
Time Frame: At baseline, at 4 weeks after treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 4, 2020
Primary Completion (Actual)
March 30, 2023
Study Completion (Actual)
June 6, 2023
Study Registration Dates
First Submitted
July 20, 2020
First Submitted That Met QC Criteria
July 22, 2020
First Posted (Actual)
July 27, 2020
Study Record Updates
Last Update Posted (Actual)
November 18, 2023
Last Update Submitted That Met QC Criteria
November 16, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 1R15DC017014-01A1 (U.S. NIH Grant/Contract)
- 0819.1s-ETSU (Other Identifier: East Tennessee State University (ETSU))
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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