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

August 4, 2021 updated by: Amanda Gillespie, Emory University

EMST And PhoRTE Training For Elderly Patients With Vocal Fold Atrophy

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Georgia
      • Atlanta, Georgia, United States, 30308
        • Emory University Hospital Midtown
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15219
        • University of Pittsburgh Voice Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

65 years to 95 years (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: PhoRTE
This group will undergo standard PhoRTE therapy.
Behavioral: PhoRTE
Completing of PhoRTE voice therapy.
Experimental: PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
Behavioral: PhoRTE
Completing of PhoRTE voice therapy.
Device: EMST
Training of the respiratory system muscles using the EMST device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Voice Handicap Index-10 (VHI-10) Score
Time Frame: 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.
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)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
AVI Score at Baseline and Follow up (5 Weeks)
Time Frame: 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.
At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)
Maximum Expiratory Pressure (MEP)
Time Frame: 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.
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Phonatory Airflow in Speech at Baseline and 5 Weeks
Time Frame: 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
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Number of Breaths at Baseline and Follow up (5 Weeks)
Time Frame: 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).
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Time Frame: 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.
Baseline (At initial therapy visit) and final follow up-visit (week 5)
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Time Frame: 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.
Baseline (At initial therapy visit) and final follow up-visit (week 5)
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Time Frame: 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).
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Time Frame: 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.
At initial therapy visit (Baseline) and final follow up-visit (after week 5)
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Time Frame: At initial therapy visit (Baseline) and final follow up-visit (week 5)
Acoustic measurement: CPP F0 while reading functional phrases.
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Time Frame: 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).
At initial therapy visit (Baseline) and final follow up-visit (week 5)
Vocal Intensity at Baseline and Follow up
Time Frame: At initial therapy visit (baseline) and final follow up-visit (week 5)
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
At initial therapy visit (baseline) and final follow up-visit (week 5)
Mean Change In Overall Voice Severity at 5 Weeks
Time Frame: 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.
At initial therapy visit and final follow up-visit, after week 5

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Emory University

Investigators

  • Principal Investigator: Amanda Gillespie, Emory University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2018

Primary Completion (Actual)

May 4, 2020

Study Completion (Actual)

May 4, 2020

Study Registration Dates

First Submitted

September 20, 2018

First Submitted That Met QC Criteria

October 3, 2018

First Posted (Actual)

October 4, 2018

Study Record Updates

Last Update Posted (Actual)

August 30, 2021

Last Update Submitted That Met QC Criteria

August 4, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00109224
  • PRO18040682 (Other Identifier: University of Pittsburgh)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

only de-identified data will be shared

IPD Sharing Time Frame

during and through data analysis

IPD Sharing Access Criteria

additional researchers may receive de-identified information only if a data use agreement has been executed.

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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