Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy
NCT ID: NCT03696576
Last Updated: 2021-08-30
Study Results
Results available
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
24 participants
Study Classification
INTERVENTIONAL
Study Start Date
2018-09-20
Study Completion Date
2020-05-04
Brief Summary
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The larynx and vocal folds undergo many age-related changes in their physiology and structure that can lead to undesirable effects on the voice, with changes in the respiratory system compounding these deficits. These changes, also called presbyphonia, can have serious detrimental effects on the lives of elderly individuals. There are few studies that have evaluated the use of voice therapy treatment options for these patients. The primary aim of this study is to test whether the addition of expiratory muscle strength training (EMST) to a current, validated voice therapy protocol aimed at treating presbyphonia, (phonation resistance training, PhoRTE) can improve outcomes of therapy.
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Detailed Description
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The purpose of this study is to test whether the addition of EMST to PhoRTE Voice Therapy is at least as effective as PhoRTE alone for improving acoustic, aerodynamic, and patient-reported outcomes in patients affected by age-related vocal fold atrophy.
Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy.
Voice therapy is often the first-line treatment for patients experiencing presbyphonia. Despite being the most common treatment for presbyphonia, scant literature exists on the efficacy of voice therapy for these patients. The current proposal aims to add to this growing body of literature. In general, studies of existing voice therapy programs for presbyphonia have demonstrated success in achieving improvement in aerodynamic (increased subglottal pressure), acoustic (increased shimmer, jitter, and decreased noise-to-harmonics ratio), and patient-centered outcomes (reduction in Voice Handicap Index scores, decreased phonatory effort). Ziegler et al. conducted a study comparing a standard voice therapy, Vocal Function Exercises (VFE) and Phonation Resistance Training Exercises (PhoRTE) and found that both therapies improved outcomes of voice-related quality of life, but only PhoRTE gave a statistically significant reduction in perceived phonatory effort. A specific therapy designed to address age-related changes to respiratory system is expiratory muscle strength training (EMST). EMST devices are loaded with a resistive spring which opens when a desired level of expiratory pressure is reached and maintained. Maintenance of consistent subglottal pressure is the foundation for phonation. EMST device training improves active expiratory muscle forces required for high-pressure activities such as long utterances or loud speech in vocally healthy individuals. When used in conjunction with traditional voice therapy, EMST use has also shown to increase maximum phonation time, maximum expiratory pressure, dynamic range, subglottal pressure, and perception of voice handicap in professional voice users over traditional voice therapy alone. The theoretical underpinnings for treatment of vocal fold atrophy with EMST are clear, as it addresses many of the common goals of treatment in patients with presbyphonia, but it has not yet been tested as a possible adjunctive treatment for patients undergoing voice therapy.
Conditions
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Voice Disorder
Vocal Cord Atrophy
Presbyphonia
Study Design
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Allocation Method
RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
SINGLE
Caregivers
Speech Language Pathologists (SLPs) will not know which group the participants have been randomized to.
Study Groups
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PhoRTE
This group will undergo standard PhoRTE therapy.
Group Type
ACTIVE_COMPARATOR
PhoRTE
Intervention Type
BEHAVIORAL
Completing of PhoRTE voice therapy.
PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
Group Type
EXPERIMENTAL
EMST
Intervention Type
DEVICE
Training of the respiratory system muscles using the EMST device.
PhoRTE
Intervention Type
BEHAVIORAL
Completing of PhoRTE voice therapy.
Interventions
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EMST
Training of the respiratory system muscles using the EMST device.
Intervention Type
DEVICE
PhoRTE
Completing of PhoRTE voice therapy.
Intervention Type
BEHAVIORAL
Eligibility Criteria
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Inclusion Criteria
* Age 65 or older
* Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist
* Willingness to be randomized to one of two treatments
* Diagnosis of presbyphonia (vocal fold atrophy) made by a fellowship-trained laryngologist and a voice specialized speech language pathologist
* Willingness to be randomized to one of two treatments
Exclusion Criteria
* Any concomitant laryngeal diagnoses or diseases known to affect voice function, including: amyloidosis, arytenoid dislocation, laryngeal cancer, cricoarytenoid fixation, vocal fold cyst(s), vocal nodules, vocal fold polyp(s), dysplasia, vocal fold fibrous mass(es), glottal web, vocal fold immobility, laryngeal stenosis, laryngocele, leukoplakia, Parkinson's disease, Reinke's edema, respiratory recurrent pneumonia, sarcoidosis, spasmodic dysphonia
* Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis
* History of acute stroke
* Untreated hypertension
* Untreated gastroesophageal reflux disease (GERD)
* Any chronic lower airway disease such as chronic obstructive pulmonary disease (COPD), asthma, chronic bronchitis, emphysema, cystic fibrosis
* History of acute stroke
* Untreated hypertension
* Untreated gastroesophageal reflux disease (GERD)
Minimum Eligible Age
65 Years
Maximum Eligible Age
95 Years
Eligible Sex
ALL
Accepts Healthy Volunteers
No
Sponsors
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Emory University
OTHER
Sponsor Role
lead
Responsible Party
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Amanda Gillespie
Assitant professor
Responsibility Role
PRINCIPAL_INVESTIGATOR
Principal Investigators
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Amanda Gillespie
Role: PRINCIPAL_INVESTIGATOR
Emory University
Locations
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Emory University Hospital Midtown
Atlanta, Georgia, United States
Site Status
University of Pittsburgh Voice Center
Pittsburgh, Pennsylvania, United States
Site Status
Countries
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United States
References
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BACKGROUND
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BACKGROUND
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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PRO18040682
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00109224
Identifier Type: -
Identifier Source: org_study_id
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