Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy

Not Applicable

Terminated

• Conditions: Vocal Cord Atrophy; Voice Disorder; Presbyphonia
• Interventions: Device: EMST; Behavioral: PhoRTE

• Registration Number: NCT03696576
• Lead Sponsor: Emory University

Brief Summary

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.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2018-09-20
• Study First Submitted: 2018-09-20
• Study First Submitted QC: 2018-10-03
• Study First Posted: 2018-10-04
• Primary Completion: 2020-05-04
• Study Completion: 2020-05-04
• Disposition First Submitted: 2021-06-17
• Results First Submitted: 2021-07-07
• Status Verified: 2021-08
• Results First Submitted QC: 2021-08-04
• Disposition First Submitted QC: 2021-08-04
• Last Update Submitted: 2021-08-04
• Results First Posted: 2021-08-30
• Disposition First Posted: 2021-08-30
• Last Update Posted: 2021-08-30

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 24

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PhoRTE + EMST	EMST	This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
PhoRTE + EMST	PhoRTE	This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
PhoRTE	PhoRTE	This group will undergo standard PhoRTE therapy.

Primary Outcome Measures

Name	Time	Method
Voice Handicap Index-10 (VHI-10) Score	At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)	The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.

Secondary Outcome Measures

Name	Time	Method
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up	At initial therapy visit (Baseline) and final follow up-visit (after week 5)	Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
AVI Score at Baseline and Follow up (5 Weeks)	At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)	The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks	Baseline (At initial therapy visit) and final follow up-visit (week 5)	Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Maximum Expiratory Pressure (MEP)	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Maximum Expiratory Pressure (MEP) was measured using a handheld manometer (Micro Direct Respiratory Pressure Meter, MicroRPM, Med-Electronics, Beltsville, MD, United States) at baseline and after 5 weeks of therapy. Participants were instructed to blow with maximum force into the MicroRPM device over 10 trials, and the participant's best three trials were used to calculate their average MEP.
Phonatory Airflow in Speech at Baseline and 5 Weeks	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Aerodynamic measures were collected and analyzed via the Phonatory Aerodynamic System 6600 (PAS; PENTAX Medical, Montvale, NJ, United States) using the first four sentences of the Rainbow Passage. Aerodynamic measures included mean airflow during voicing and number of breaths taken. The PAS captured phonatory aerodynamic functioning using a pneumotach coupled to a facemask, with external microphone. During speech, expired air flows through the pneumotach, which consists of a stainless-steel mesh screen with pressure transducers on either side. The system calculates the pressure difference across the screen to determine airflow rate. The microphone is positioned at the end of the pneumotach and internally calibrated per system specifications to represent a mouth-to-microphone distance of 15 cm. The participant sat with the facemask held snugly over their nose and mouth while they read the first fou
Number of Breaths at Baseline and Follow up (5 Weeks)	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Acoustic measurement: CPP F0 while reading functional phrases.
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks	Baseline (At initial therapy visit) and final follow up-visit (week 5)	Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks	At initial therapy visit (Baseline) and final follow up-visit (week 5)	Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Vocal Intensity at Baseline and Follow up	At initial therapy visit (baseline) and final follow up-visit (week 5)	Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Mean Change In Overall Voice Severity at 5 Weeks	At initial therapy visit and final follow up-visit, after week 5	Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.

Trial Locations

Locations (2)

University of Pittsburgh Voice Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Emory University Hospital Midtown; 🇺🇸 Atlanta, Georgia, United States