Vocal Warm-up and Respiratory Muscle Training

Voice Disorders Clinical Trial

Official title:

Vocal Warm-up and Respiratory Training in Teachers: a Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02102399
• Other study ID #: U1111-1152-9129
• Status: Completed
• Phase: N/A
• First received: March 30, 2014
• Last updated: September 23, 2015
• Start date: July 2013
• Est. completion date: September 2013

Study information

• Verified date: September 2015
• Source: Federal University of Bahia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to verify the effects of two speech-pathology interventions: vocal warm-up and respiratory training in teachers who work in a public school of the city of Salvador-Bahia, with or without complaints of vocal disorders. It is a preventive study and the hypothesis is that both approaches can produce positive voice changes, but the Vocal Warm-up will produce the most significant changes.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 41
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Voice Disorders

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Brazil	Federal University of Bahia	Salvador	Bahia

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Bahia	Bahia State Secretariat of Education, Brazil

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Voice Handicap Index (VHI-10)	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	No
Primary	Acoustic Analysis (Fundamental Frequency)	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	No
Primary	Acoustic Analysis (Jitter)	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	No
Primary	Acoustic Analysis (Shimmer)	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	No
Primary	Acoustic Analysis (Noise)	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	No
Primary	Acoustic Analysis (GNE)	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	No
Primary	Voice Handicap Index (VHI-10) 2	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	No
Primary	Acoustic Analysis (Fundamental Frequency) 2	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	No
Primary	Acoustic Analysis (Jitter) 2	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	No
Primary	Acoustic Analysis (Shimmer) 2	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	No
Primary	Acoustic Analysis (Noise) 2	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	No
Primary	Acoustic Analysis (GNE) 2	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	No
Primary	Change in Voice Handicap Index (VHI-10)	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	No
Primary	Change in Fundamental Frequency	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	No
Primary	Change in Jitter	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	No
Primary	Change in Shimmer	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	No
Primary	Change in Noise	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	No
Primary	Change in GNE	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	No
Secondary	Post-treatment Questionnaire (Voice Symptoms Improvement)	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	No
Secondary	Post-treatment Questionnaire (Voice Clearer)	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	No
Secondary	Post-treatment Questionnaire (Easier to Talk)	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	No
Secondary	Post-treatment Questionnaire (Compliance With 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	No