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Treatment for Teachers With Vocal Fatigue

Primary Purpose

Vocal Fatigue, Treatment

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cardiovascular Conditioning Protocol
Voice Production Exercises
Sponsored by
East Tennessee State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Vocal Fatigue

Eligibility Criteria

21 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • East Tennessee State UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Cardiovascular Conditioning Protocol

Voice Production Exercises

Arm Description

Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.

Participants will complete voice production exercises twice per week for a period of 4 weeks.

Outcomes

Primary Outcome Measures

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
Changes in Oxygen Uptake Kinetics
Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks
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
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
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
Changes in Vocal Fatigue Index (VFI)
Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue
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

Secondary Outcome Measures

Full Information

First Posted
July 20, 2020
Last Updated
June 15, 2022
Sponsor
East Tennessee State University
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1. Study Identification

Unique Protocol Identification Number
NCT04486989
Brief Title
Treatment for Teachers With Vocal Fatigue
Official Title
Cardiovascular Conditioning in the Treatment of Vocal Fatigue
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2020 (Actual)
Primary Completion Date
May 16, 2023 (Anticipated)
Study Completion Date
July 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
East Tennessee State University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vocal Fatigue, Treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
52 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Cardiovascular Conditioning Protocol
Arm Type
Experimental
Arm Description
Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks.
Arm Title
Voice Production Exercises
Arm Type
Active Comparator
Arm Description
Participants will complete voice production exercises twice per week for a period of 4 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Cardiovascular Conditioning Protocol
Intervention Description
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
Intervention Type
Other
Intervention Name(s)
Voice Production Exercises
Intervention Description
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
Primary Outcome Measure Information:
Title
Changes in Physiologic Cost of Speaking
Description
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
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Oxygen Uptake Kinetics
Description
Oxygen Uptake Kinetics is measured as the pattern of oxygen use during each of the two reading tasks
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Post Task Physiological Recovery
Description
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
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Excess Post Exercise Consumption (EPOC)
Description
EPOC is measured as the magnitude of recovery oxygen consumption, ml/kg/min for each of the reading tasks
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Ratings of Perceived Exertion (RPE)
Description
Borg Scale of Ratings of Perceived Exertion (RPE)- measures the self-report of vocal effort for each of the reading tasks
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Vocal Fatigue Index (VFI)
Description
Vocal Fatigue Index (VFI) is a retrospective scale that measures self-reported symptoms of vocal fatigue
Time Frame
At baseline, at 4 weeks after treatment
Title
Changes in Global Rating of Vocal Fatigue (VAS 100mm)
Description
Global Rating of Vocal Fatigue (VAS 100mm) measures the ability to sustain voice with no fatigue at the end of a working day
Time Frame
At baseline, at 4 weeks after treatment

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chaya Nanjundeswaran (Guntupalli), Ph.D.
Phone
423-439-4036
Email
nanjundeswar@etsu.edu
Facility Information:
Facility Name
East Tennessee State University
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37614
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chaya Nanjundeswarn (Guntupalli), Ph.D.
Phone
423-439-4036
Email
nanjundeswar@etsu.edu

12. IPD Sharing Statement

Plan to Share IPD
No

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Treatment for Teachers With Vocal Fatigue

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