- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02102399
Vocal Warm-up and Respiratory Muscle Training
Vocal Warm-up and Respiratory Training in Teachers: a Randomized Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Randomized Clinical Trial where participants were allocated into groups: Vocal Warm-up (to perform exercises of resistance and flexibility for 13 minutes before teaching, during six weeks) and Respiratory Muscle Training (to perform exercises to strengthen the respiratory muscles through the use of incentive respiratory equipment. Five repetitions of exhales with an interval of thirty seconds between each one were performed. It was requested rest for two minutes, repeating the procedure four times with the total of five series. These exercises were performed for 13 minutes before teaching, during six weeks).
Outcomes analyzed: demographics and teaching activity characteristics; symptoms, habits and factors associated with voice disorders; self-reported voice handicap (Voice Handicap Index-VHI-10); vocal severity rating (Vocal Severity Scale); and acoustic parameters through the computerized acoustic voice analysis program VoxMetria (CTS Informatics).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Bahia
-
Salvador, Bahia, Brazil, 40.026-010
- Federal University of Bahia
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 20-60.
- No occurence of speech therapy simultaneously to the intervention
Exclusion Criteria:
- Professional voice use in another activity;
- Frequent use of alcohol and tobacco;
- Influenza and/or upper respiratory tract infections (eg, rhinitis, sinusitis, pharyngitis) during the period of participation in the research.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vocal Warm-up
Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
|
Vocal Warm-up group performed 13 minutes of vocal warm-up exercises everyday before teaching over a course of 6 weeks, with one session exercise per day.
|
Experimental: Respiratory Muscle Training
Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
|
Respiratory Muscle Training group performed 13 minutes of Respiratory Muscle Training everyday before teaching over a course of 6 weeks, with one session exercise per day.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Voice Handicap Index (VHI-10)
Time Frame: Baseline, 6 weeks
|
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life.
The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject.
It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always).
Total VHI Score ranges from 0 (never) to 40 (always).
Higher scores indicate greater voice handicap.
Abnormal values > 11.
|
Baseline, 6 weeks
|
Acoustic Analysis (Fundamental Frequency)
Time Frame: Baseline, 6 weeks
|
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds.
The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
|
Baseline, 6 weeks
|
Acoustic Analysis (Jitter)
Time Frame: Baseline, 6 weeks
|
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%. |
Baseline, 6 weeks
|
Acoustic Analysis (Shimmer)
Time Frame: Baseline, 6 weeks
|
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%. |
Baseline, 6 weeks
|
Acoustic Analysis (Noise)
Time Frame: Baseline, 6 weeks
|
Noise is the analysis of aperiodic components of the sound's signal.
It is an important correlate of that the human ear considers voice disorders.
Normal levels < 2.5 dB
|
Baseline, 6 weeks
|
Acoustic Analysis (GNE)
Time Frame: Baseline, 6 weeks
|
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB |
Baseline, 6 weeks
|
Voice Handicap Index (VHI-10) 2
Time Frame: Baseline, 6 weeks
|
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life.
The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject.
It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always).
Total VHI Score ranges from 0 (never) to 40 (always).
Higher scores indicate greater voice handicap.
Abnormal values > 11.
|
Baseline, 6 weeks
|
Acoustic Analysis (Fundamental Frequency) 2
Time Frame: Baseline, 6 weeks
|
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds.
The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
|
Baseline, 6 weeks
|
Acoustic Analysis (Jitter) 2
Time Frame: Baseline, 6 weeks
|
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%. |
Baseline, 6 weeks
|
Acoustic Analysis (Shimmer) 2
Time Frame: Baseline, 6 weeks
|
The shimmer measures the amplitude's disturbance, e. g. how fast the amplitude changes on a sustained vowel for a few seconds. Shimmer high levels are normally associated with pathological voice. This can be attributed due to changes in size, shape or firmness of the vocal folds. Normal values < 6.5%. |
Baseline, 6 weeks
|
Acoustic Analysis (Noise) 2
Time Frame: Baseline, 6 weeks
|
Noise is the analysis of aperiodic components of the sound's signal.
It is an important correlate of that the human ear considers voice disorders.
Normal levels < 2.5 dB
|
Baseline, 6 weeks
|
Acoustic Analysis (GNE) 2
Time Frame: Baseline, 6 weeks
|
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB |
Baseline, 6 weeks
|
Change in Voice Handicap Index (VHI-10)
Time Frame: Baseline, 6 weeks
|
The voice handicap index (VHI) is a self-assessment questionnaire which quantifies the functional, physical and emotional impacts of a voice disorder on the quality of life.
The VHI-10 is a reduced version and it consists of 10 questions about the severity of the voice problem perceived by the subject.
It is presented as an ordinal scale (range 0-4) that indicates how frequently the subject has experienced the same situation (0 = never; 1 = almost never; 2 = sometimes; 3= almost always; 4 = always).
Total VHI Score ranges from 0 (never) to 40 (always).
Higher scores indicate greater voice handicap.
Abnormal values > 11.
|
Baseline, 6 weeks
|
Change in Fundamental Frequency
Time Frame: Baseline, 6 weeks
|
The measurement of fundamental frequency directly reflects the rate of vibration of the vocal folds.
The fundamental frequency term refers to the frequency of more occurrence of vocal fold vibration, featuring a certain production.
|
Baseline, 6 weeks
|
Change in Jitter
Time Frame: Baseline, 6 weeks
|
Jitter is the perturbation cycle-to-cycle of the fundamental frequency. High levels of jitter are normally associated with pathological voice. The instability of the fundamental frequency can be attributed to changes in size, shape or firmness of the vocal folds. Normal values must be < 0.6%. |
Baseline, 6 weeks
|
Change in Shimmer
Time Frame: Baseline, 6 weeks
|
Shimmer measures the amplitude perturbations, e. g. how fast the amplitude changes on a sustained vowel for a few seconds.
Shimmer high levels are normally associated with pathological voice.
This can be attributed due to changes in size, shape or firmness of the vocal folds.
Normal values < 6.5%
|
Baseline, 6 weeks
|
Change in Noise
Time Frame: Baseline, 6 weeks
|
Noise is the analysis of aperiodic components of the sound's signal.
It is an important correlate of that the human ear considers voice disorders.
Normal levels < 2.5 dB
|
Baseline, 6 weeks
|
Change in GNE
Time Frame: Baseline, 6 weeks
|
Glottal to Noise Excitation ratio (GNE) is an acoustic measurement to calculate the noise in a series of pulses produced by the oscillation of the vocal folds. This parameter is based on the hypothesis that resulting pulses of vocal fold collision generate a synchronous excitation of different frequency bands. Moreover, the noise produced by the vocal folds compressed generates uncorrelated excitations. Normal levels > 0.5 dB |
Baseline, 6 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Post-treatment Questionnaire (Voice Symptoms Improvement)
Time Frame: After 6 weeks of intervention
|
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention.
Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot").
The questionnaire was applied only after the intervention.
The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat").
The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
|
After 6 weeks of intervention
|
Post-treatment Questionnaire (Voice Clearer)
Time Frame: After 6 weeks of intervention
|
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention.
Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot").
The questionnaire was applied only after the intervention.
The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat").
The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
|
After 6 weeks of intervention
|
Post-treatment Questionnaire (Easier to Talk)
Time Frame: After 6 weeks of intervention
|
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention.
Participants rated their extent of improvement on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot").
The questionnaire was applied only after the intervention.
The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat").
The results were presented in frequency/percentage of subjects that answered "moderate/a lot" in each intervention.
|
After 6 weeks of intervention
|
Post-treatment Questionnaire (Compliance With Intervention)
Time Frame: After 6 weeks of intervention
|
The post-treatment questionnaire was based on the original designed by Roy (2003) for assessing the teachers' perception of voice improvement and compliance with the intervention.
Participants rated their degree of compliance on a 3-point Likert scale ("not at all/somewhat"; "moderate"; "a lot").
The questionnaire was applied only after the intervention.
The answers were dichotomized in two categories ("moderate/a lot" and "not at all/somewhat").
It was considered compliance the answers "moderate" and "a lot" in comparison of "not at all/somewhat", considered as no compliance.
The results were presented in frequency/percentage of subjects in each intervention.
|
After 6 weeks of intervention
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Maria Lucia V Masson, PhD, Federal University of Bahia
- Study Chair: Lilian Paternostro, MS, Federal University of Bahia
- Study Director: Fernando M Carvalho, PhD, Federal University of Bahia
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- U1111-1152-9129
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