TerminatedNot Applicable

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

Stopped: Due to the pandemic, recruitment ended earlier than expected and changes were required to alter data collection methods (and were approved by the IRB). Additional changes were also made to the protocol to move the study to an online platform.

United States24 participantsStarted 2018-09-20

Plain-language 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.

Who can participate

Age range65 Years – 95 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

What they're measuring

Voice Handicap Index-10 (VHI-10) Score

Timeframe: 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)

Trial details

NCT IDNCT03696576

SponsorEmory University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-05-04

Results submitted2021-07-07