Vocal FatigueNCT04486989
Treatment for Teachers With Vocal Fatigue
A study testing Cardiovascular Conditioning Protocol and Voice Production Exercises in people with Vocal Fatigue and Treatment, run by East Tennessee State University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 21 to 60 years, women only
- Conditions the study is for
- Vocal Fatigue, Treatment
- What is being tested?
- Cardiovascular Conditioning Protocol and Voice Production Exercises
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Feb 2020to 6 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- Trained athletes
- Trained singers
- Smoking in the past 6months
- Prior history of a vocal fold pathology and current vocal fold pathology
Trial locations and contacts
1 site in 1 country.
United States1 site
East Tennessee State University
Johnson City, Tennessee, 37614
About this study
Official title: 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.
- Conditions
- Vocal Fatigue, Treatment
- Being tested
- Cardiovascular Conditioning Protocol, Voice Production Exercises
- Medical subject headings
- Voice Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiovascular Conditioning ProtocolBehavioural
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
Voice Production ExercisesOther
Participants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Cardiovascular Conditioning Protocol | Experimental | Participants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks. Receives: Behavioral: Cardiovascular Conditioning Protocol |
| Voice Production Exercises | Active comparator | Participants will complete voice production exercises twice per week for a period of 4 weeks. Receives: Other: Voice Production Exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: At baseline, at 4 weeks after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start4 Feb 2020
- Primary completion30 Mar 2023
- Study completion6 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal FatigueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Tennessee State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chayadevie Nanjundeswaran, East Tennessee State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04486989
- Sponsor's protocol ID
- 1R15DC017014-01A1
- Other IDs
- 0819.1s-ETSU
- Status last verified
- Nov 2023
- First submitted
- 20 Jul 2020
- Last updated
- 18 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiovascular Conditioning in the Treatment of Vocal Fatigue
- ClinicalTrials.gov ID
- NCT04486989
- Acronym / sponsor ID
- 1R15DC017014-01A1
- Conditions
- Vocal Fatigue, Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- East Tennessee State UniversityUniversity, hospital or other
- Study start
- 4 Feb 2020 (actual)
- Primary completion
- 30 Mar 2023 (actual)
- Study completion
- 6 Jun 2023 (actual)
- First posted
- 27 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cardiovascular Conditioning Protocol | Experimental | Behavioral: Cardiovascular Conditioning ProtocolParticipants will complete a sub maximal cardiovascular training program twice per week for a period of 4 weeks. |
| Voice Production Exercises | Active comparator | Other: Voice Production ExercisesParticipants will complete voice production exercises twice per week for a period of 4 weeks. |
Who may qualify
- Ages
- 21 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- Trained athletes
- Trained singers
- Smoking in the past 6months
- Prior history of a vocal fold pathology and current vocal fold pathology
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cardiovascular Conditioning ProtocolParticipants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks. | Behavioural | Cardiovascular Conditioning Protocol |
| Voice Production ExercisesParticipants will be randomized to either one of the treatment arms to receive treatment for a period of 4 weeks. | Other | Voice Production Exercises |
Primary outcome
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
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
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
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
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
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- Individual participant dataSharing planned: No
Related trials for Vocal Fatigue
Active, not recruiting
Straw Phonation Exercise Program for Pitch Extension
Voice Fatigue, Voice Disorders
Not yet recruiting
"Effects of EMST and Triflo on Voice Parameters and Vocal Fatigue"
Voice Fatigue, Voice Disorder
Recruiting
Brain and Voice Signatures in Teachers
Voice Disorders, Voice Fatigue
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cardiovascular Conditioning Protocol and Voice Production Exercises in people with Vocal Fatigue and Treatment, run by East Tennessee State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Changes in Physiologic Cost of Speaking (time frame: At baseline, at 4 weeks after treatment). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Nov 2023.