The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Adam Lloyd，University of Miami

Tracking Information

First Submitted Date ^ICMJE

September 26, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 2, 2018

Actual Study Start Date ^ICMJE

November 1, 2018

Estimated Primary Completion Date

December 1, 2020 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Maximum expiratory pressure[ Time Frame: 16 weeks ]

Maximum expiratory pressure, in cm of H2O, will be measured to evaluate how much pressure a participant can blow into a respiratory pressure meter.

Amplitude[ Time Frame: 16 weeks ]

Amplitude of voice, in decibels, will be measured using handheld digital SPL meter values will be compared to gender matched normative values for normal and loud volumes.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Fundamental frequency[ Time Frame: 16 weeks ]
Fundamental frequency, measured in herz, will be obtained using the Multidimensional Voice Profile on Kay Pentax Computerized Speech Lab.
Dynamic pitch range[ Time Frame: 16 weeks ]
Dynamic pitch range will be measured using Voice Range Profile on Kay Pentax Computerized Speech Lab.
Jitter[ Time Frame: 16 weeks ]
Jitter, measured in relative average perturbation, will be obtained using the Multidimensional Voice Profile on Kay Pentax Computerized Speech Lab.
Shimmer[ Time Frame: 16 weeks ]
Shimmer, measured in decibels, will be obtained using the Multidimensional Voice Profile on Kay Pentax Computerized Speech Lab.
Noise to harmonic ratio[ Time Frame: 16 weeks ]
Noise to harmonic ratio, which is measured in a ratio, will be obtained using the Multidimensional Voice Profile on Kay Pentax Computerized Speech Lab.
Voice Handicap Index[ Time Frame: 16 weeks ]
This is quality of life assessment tool quantifying perception of the impact of their vocal disorder on various aspects of lifestyle. It is 30-questions in length and is divided into 3 subscales including emotional, physical, and functional, divided into 10 questions each. Each question scored from 0-4. Total score range from 0-120. Higher score indicates increased handicap.
Maximum phonation time[ Time Frame: 16 weeks ]
The patient will be asked to inhale deeply and sustain the vowel /a/ at a comfortable loudness level for a many seconds as possible.
Peak expiratory flow rate[ Time Frame: 16 weeks ]
Peak expiratory flow rate, measured in units of liters per minute, will be measured for purposes of measuring cough function.

Descriptive Information

Brief Title ^ICMJE

The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Official Title ^ICMJE

The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

Brief Summary

Evaluate if adding expiratory muscle strength training to traditional voice therapy for individuals with dysphonia due to glottal insufficiency improves maximal expiratory pressure, acoustic and aerodynamic measures (i.e. amplitude, maximum phonation time, peak expiratory flow), and voice related quality of life.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Other: Standard of care voice therapy
Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder
Device: Expiratory muscle strength training (EMST)
EMST150 used at 75% of their maximum expiratory pressure. Participants will be directed to perform 5 sets of 5 breaths, 5 days per week, for 5 weeks, at the pressure threshold established in therapy. Maximum expiratory pressure will then be determined at the beginning of each therapy session and recalibration of the device will be performed if indicated.

Study Arms

Experimental: Unilateral vocal fold paralysis standard of care voice therapy
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques.
Experimental: Unilateral paralysis standard of care voice therapy plus EMST
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.
Experimental: Parkinson's disease standard of care voice therapy plus EMST
The participants will receive the standard of voice therapy including improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relations techniques. EMST consists of blowing into respiratory device at a measure threshold pressure. As strength improves threshold resistance will be increased.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

120

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

March 1, 2021

Estimated Primary Completion Date

December 1, 2020 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Individuals with glottic insufficiency. - Adequate cognition evidenced by score of 24 or higher on the Mini-Mental State Examination (MMSE) survey to determine if the subject has the mental capacity to participate in therapy - Completed voice combination evaluation with speech pathologists and otolaryngologist. - Individuals 18 years of age or older Exclusion Criteria: - Adults unable to consent - Non English or Spanish speakers - Pregnant women - Prisoners - Individuals with significant uncontrolled chronic and progressive respiratory diseases including COPD, interstitial lung disease, and cystic fibrosis. - Individuals with uncontrolled blood pressure. - Individuals with significant GI disease and/or gastroesophageal surgery with the exception of well-controlled GERD. - Individuals with a history of abdominal hernia. - Individuals with difficulty complying due to neuropsychological dysfunction (e.g., severe depression, psychosis). - Individuals with other neurological disorders and/or neuromuscular disease other than Parkinson's Disease

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Adam Lloyd，University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Miami

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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