The Effects of Adding Expiratory Muscle Strength Training in Voice Therapy

NCT ID: NCT03692494

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-12-01

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.

Conditions

Dysphonia; Unilateral Vocal Cord Paralysis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Standard of care voice therapy

Intervention Type: OTHER

Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder

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.

Group Type: EXPERIMENTAL

Standard of care voice therapy

Intervention Type: OTHER

Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder

Expiratory muscle strength training (EMST)

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

Standard of care voice therapy

Intervention Type: OTHER

Exercises will include improved breath coordination, sustained humming and vowels, vocal glides, resonant voice therapy, and relaxation techniques to the neck and shoulder

Expiratory muscle strength training (EMST)

Intervention Type: OTHER

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.

Interventions

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

Intervention Type: OTHER

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Miami

OTHER

Sponsor Role: lead

Responsible Party

Adam Lloyd

Speech Pathologist

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Adam T Lloyd, SLP-D, MM, MA

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

University of Miami

Miami, Florida, United States

Countries

United States

Other Identifiers

20171103

Identifier Type: -

Identifier Source: org_study_id