Vocal Warm-up and Respiratory Muscle Training

This study has been completed.
Sponsor:
Collaborator:
Bahia State Secretariat of Education, Brazil
Information provided by (Responsible Party):
Maria Lucia Vaz Masson, Federal University of Bahia
ClinicalTrials.gov Identifier:
NCT02102399
First received: March 30, 2014
Last updated: September 23, 2015
Last verified: September 2015
  Purpose
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.

Condition Intervention
Voice Disorders
Behavioral: Vocal Warm-up
Behavioral: Respiratory Muscle Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Vocal Warm-up and Respiratory Training in Teachers: a Randomized Clinical Trial

Resource links provided by NLM:


Further study details as provided by Federal University of Bahia:

Primary Outcome Measures:
  • Voice Handicap Index (VHI-10) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Acoustic Analysis (Fundamental Frequency) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Acoustic Analysis (Jitter) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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%.


  • Acoustic Analysis (Shimmer) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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%.


  • Acoustic Analysis (Noise) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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

  • Acoustic Analysis (GNE) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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


  • Voice Handicap Index (VHI-10) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Acoustic Analysis (Fundamental Frequency) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Acoustic Analysis (Jitter) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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%.


  • Acoustic Analysis (Shimmer) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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%.


  • Acoustic Analysis (Noise) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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

  • Acoustic Analysis (GNE) 2 [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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


  • Change in Voice Handicap Index (VHI-10) [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Fundamental Frequency [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Change in Jitter [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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%.


  • Change in Shimmer [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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%

  • Change in Noise [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]
    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

  • Change in GNE [ Time Frame: Baseline, 6 weeks ] [ Designated as safety issue: No ]

    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



Secondary Outcome Measures:
  • Post-treatment Questionnaire (Voice Symptoms Improvement) [ Time Frame: After 6 weeks of intervention ] [ Designated as safety issue: No ]
    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.

  • Post-treatment Questionnaire (Voice Clearer) [ Time Frame: After 6 weeks of intervention ] [ Designated as safety issue: No ]
    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.

  • Post-treatment Questionnaire (Easier to Talk) [ Time Frame: After 6 weeks of intervention ] [ Designated as safety issue: No ]
    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.

  • Post-treatment Questionnaire (Compliance With Intervention) [ Time Frame: After 6 weeks of intervention ] [ Designated as safety issue: No ]
    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.


Enrollment: 41
Study Start Date: July 2013
Study Completion Date: September 2013
Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
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.
Behavioral: 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.

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).

  Eligibility

Ages Eligible for Study:   20 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02102399

Locations
Brazil
Federal University of Bahia
Salvador, Bahia, Brazil, 40.026-010
Sponsors and Collaborators
Federal University of Bahia
Bahia State Secretariat of Education, Brazil
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
  More Information

No publications provided by Federal University of Bahia

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Maria Lucia Vaz Masson, Federal University of Bahia
ClinicalTrials.gov Identifier: NCT02102399     History of Changes
Other Study ID Numbers: U1111-1152-9129 
Study First Received: March 30, 2014
Results First Received: January 24, 2015
Last Updated: September 23, 2015
Health Authority: Brazil: National Committee of Ethics in Research

Keywords provided by Federal University of Bahia:
Voice training
Education
Voice
Faculty

Additional relevant MeSH terms:
Voice Disorders
Laryngeal Diseases
Nervous System Diseases
Neurologic Manifestations
Otorhinolaryngologic Diseases
Respiratory Tract Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on February 11, 2016