Respiratory Muscle Strength Training in Presbyphonia

Presbyphonia is an age-related voice disorder that affects more than 10 million people in the United States. Presbyphonia is characterized by vocal fold atrophy that impairs older individuals' ability to communicate, leading to social isolation and reduced quality of life. Outcomes from current treatment approaches are often suboptimal for patients with presbyphonia as they do not sufficiently challenge the respiratory system to induce meaningful change. It is highly likely that the addition of respiratory training would result in greatly improved outcomes, such as the ability to speak loud and long enough to have a normal conversation. The purpose of this study will be to examine the effect of adding inspiratory muscle strength training (IMST) or expiratory muscle strength training (EMST) to standard of care voice therapy on respiratory and voice outcomes in patients with an age-related voice disorder.

Forty-eight participants diagnosed with presbyphonia will be blocked-randomized into three intervention groups, using a 3-parallel arm design: IMST and voice exercises, EMST and voice exercises, and voice exercises during all session. Study endpoints will be the change in voice and respiratory measures after four treatment sessions compared to baseline values. Response to treatment will be analyzed to determine if there are subgroups of high- or low-responders based on baseline voice and respiratory characteristics.

Study Overview

• Status: Completed
• Conditions: Presbylarynx
• Intervention / Treatment: Device: Inspiratory Muscle Strength Training (IMST); Behavioral: Voice Exercises; Device: Expiratory Muscle Strength Training (EMST)

• Study Type: Interventional
• Enrollment (Actual): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • South Carolina
    • Charleston, South Carolina, United States, 29403
      • Medical University of South Carolina

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 46 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• must receive a diagnosis of presbyphonia by a trained laryngologist. The diagnosis will be given following a visual examination if the observations are consistent with the characteristics of a presbylarynx, as judged by the laryngologist.
• must be 50 years old and older.

Exclusion Criteria:

• has received voice therapy in the past year
• presents with a vocal fold pathology other than presbyphonia
• has a known neurologic or a progressive neuromuscular disease
• has a medical condition that could be aggravated by the experimental intervention, or any condition judged by the physician (Dr. Halstead) as being unsuitable for RMST.
• has dysarthria or a language disorder
• has a hearing loss that is not adequately managed
• has a cognitive disorder that might affect treatment compliance
• is unable to give informed consent

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Inspiratory Muscle Strength Training; The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST). The IMST intervention will consist of 5 sets of 5 breaths in the inspiratory threshold device every day during four weeks, with a loading dose set at 75% of the participants' maximal inspiratory pressure (MIP). MIP will be measured once a week during the weekly supervised session to adjust the inspiratory trainer.	Device: Inspiratory Muscle Strength Training (IMST); IMST will be conducted using an inspiratory pressure threshold trainer (Philips Respironics® Threshold IMT or POWERbreathe® Medic Plus), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing in forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.; Other Names: Inspiratory muscle training (IMT); Respiratory muscle training (RMT); Respiratory muscle strength training (RMST); Philips Respironics® Threshold IMT; POWERbreathe® Medic Plus; Behavioral: Voice Exercises; Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement.
Experimental: Expiratory Muscle Strength Training; The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST). The EMST intervention will consist of 5 sets of 5 breaths in the expiratory threshold device every day during four weeks, with a loading dose set at 75% of the participants' maximal expiratory pressure (MEP). MEP will be measured once a week during the weekly supervised session to adjust the inspiratory trainer.	Behavioral: Voice Exercises; Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement.; Device: Expiratory Muscle Strength Training (EMST); EMST will be conducted using an expiratory pressure threshold trainer (EMST150®), which consists of a mouthpiece with a spring-loaded valve. The valve blocks the airflow until the threshold pressure is achieved by breathing out forcefully into the device. This allows airflow as long as the sufficient pressure is maintained.; Other Names: Respiratory muscle training (RMT); Respiratory muscle strength training (RMST); Expiratory muscle training (EMT); EMST150®
Active Comparator: Voice Exercises; The participants in the voice exercises group will receive standard of care voice therapy with a speech language pathologist, once a week during four weeks, plus daily practices.	Behavioral: Voice Exercises; Voice exercises will consist of the Vocal Function Exercises (VFE) protocol, developed by Stemple (2005). It contains 4 steps: (a) sustain the vowel /i/ on the musical note F for as long as possible. Repeat as judged by the SLP. (b) Glide from the lowest note to the highest note. Repeat as judged by the SLP. (c) Glide from the highest note to the lowest note. Repeat as judged by the SLP. (d) Sustain the notes C-D-E-F-G for as long as possible. Each note will be repeated until the participant finds the right placement (forward-focused voice), as judged by the SLP. Humming will be used to facilitate placement.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-Treatment Mean in Voice Handicap Index Score	Voice Handicap Index-10 (ordinal scale that measures the degree of handicap a person experiences because of their voice disorder. Minimum score 0, maximal score 40. A lower score is better )	up to 5 weeks after baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-treatment Mean in (Habitual) Sound Pressure Level	Acoustic measure of loudness, in Decibels	up to 5 weeks after baseline
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)	Acoustic measure of voice quality, in Decibels	up to 5 weeks after baseline
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)	Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.	up to 5 weeks after baseline
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)	Acoustic measure of voice quality, expressed as a percentage	up to 5 weeks after baseline
Post-treatment Mean in Overall Severity of Voice Quality	This is a auditory-perceptual measure rated on the standardized form: Consensus Auditory-Perceptual Evaluation of Voice (a 100-mm visual analogue scale where 0 represents a normal voice and 100 represents an extremely disrupted voice quality. A lower score is better).	up to 5 weeks after baseline
Post-treatment Mean in Baseline Bowing Index	Measure of vocal fold atrophy, calculated as the length of the membranous vocal fold/distance from the edge x100. The index was calculated based on still images from the larynx obtained from videostroboscopy. A smaller bowing index is indicative of less atrophy, and is therefore a better outcome. A greater bowing index is indicative of more atrophy and represent a worse outcome.	up to 5 weeks after baseline
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score	Ordinal scale measuring the impact of the communication disorder on various situations. A higher score is indicative of a more functional communication (the minimum score is 0 and the maximum score is 30).	up to 5 weeks after baseline
Post-treatment Mean in Glottal Function Index (GFI) Score	Glottal Function Index (ordinal scale that measures the presence and degree of symptoms of glottal dysfunction experienced by a patient. Minimum score is 0, maximum score is 20. A lower score is better).	up to 5 weeks after baseline
Post-treatment Mean in Average Glottal Airflow	Aerodynamic measure of voice expressed in Liters/second	up to 5 weeks after baseline
Post-treatment Mean in Average Subglottal Pressure	Aerodynamic measure of voice expressed in cmH20	up to 5 weeks after baseline
Post-treatment Mean in Aerodynamic Resistance	Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second	up to 5 weeks after baseline
Post-treatment Mean in Maximum Expiratory Pressure (MEP)	Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20	up to 5 weeks after baseline
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)	Indirect measure of respiratory muscle strength, expressed in cmH20	up to 5 weeks after baseline
Post-treatment Mean in Forced Vital Capacity (FVC)	Measure of pulmonary function, expressed as a percent predicted value	up to 5 weeks after baseline
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)	Measure of pulmonary function expressed as percent predicted value	up to 5 weeks after baseline
Post-Treatment Mean for FEV1/FVC	Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)	up to 5 weeks after baseline

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Voice-Vibratory Assessment With Laryngeal Imaging	exploratory measure	up to 5 weeks after baseline

Collaborators and Investigators

• Sponsor: Medical University of South Carolina
• Investigators: Principal Investigator: Heather Bonilha, PhD, Medical University of South Carolina; Study Director: Maude Desjardins, M.Sc., Medical University of South Carolina

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2018
• Primary Completion (Actual): June 25, 2019
• Study Completion (Actual): July 16, 2019

Study Registration Dates

• First Submitted: May 22, 2018
• First Submitted That Met QC Criteria: June 4, 2018
• First Posted (Actual): June 15, 2018

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: August 19, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 00064753

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

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.: No