NCT04486989

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 4, 2020

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

July 20, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 27, 2020

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 6, 2023

Completed
Last Updated

November 18, 2023

Status Verified

November 1, 2023

Enrollment Period

3.2 years

First QC Date

July 20, 2020

Last Update Submit

November 16, 2023

Conditions

Outcome Measures

Primary Outcomes (7)

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Cardiovascular Conditioning Protocol

EXPERIMENTAL

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

Behavioral: Cardiovascular Conditioning Protocol

Voice Production Exercises

ACTIVE COMPARATOR

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

Other: Voice Production Exercises

Interventions

Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.

Cardiovascular Conditioning Protocol

Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.

Voice Production Exercises

Eligibility Criteria

Age21 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • Trained athletes
  • Trained singers
  • Smoking in the past 6months
  • Prior history of a vocal fold pathology and current vocal fold pathology

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

East Tennessee State University

Johnson City, Tennessee, 37614, United States

Location

MeSH Terms

Conditions

Voice Disorders

Condition Hierarchy (Ancestors)

Laryngeal DiseasesRespiratory Tract DiseasesOtorhinolaryngologic DiseasesNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

July 20, 2020

First Posted

July 27, 2020

Study Start

February 4, 2020

Primary Completion

March 30, 2023

Study Completion

June 6, 2023

Last Updated

November 18, 2023

Record last verified: 2023-11

Data Sharing

IPD Sharing
Will not share

Locations