Respiratory Muscle Strength Training in Presbyphonia

Not Applicable

Completed

• Conditions: Presbylarynx
• Interventions: Device: Inspiratory Muscle Strength Training (IMST); Device: Expiratory Muscle Strength Training (EMST); Behavioral: Voice Exercises

• Registration Number: NCT03557775
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2018-05-22
• Study First Submitted QC: 2018-06-04
• Study Start: 2018-06-15
• Study First Posted: 2018-06-15
• Primary Completion: 2019-06-25
• Study Completion: 2019-07-16
• Results First Submitted: 2020-06-24
• Status Verified: 2020-08
• Results First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Results First Posted: 2020-09-07
• Last Update Posted: 2020-09-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Expiratory Muscle Strength Training	Voice Exercises	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.
Inspiratory Muscle Strength Training	Inspiratory Muscle Strength Training (IMST)	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.
Expiratory Muscle Strength Training	Expiratory Muscle Strength Training (EMST)	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.
Voice Exercises	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.
Inspiratory Muscle Strength Training	Voice Exercises	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.

Primary Outcome Measures

Name	Time	Method
Post-Treatment Mean in Voice Handicap Index Score	up to 5 weeks after baseline	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 )

Secondary Outcome Measures

Name	Time	Method
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)	up to 5 weeks after baseline	Acoustic measure of voice quality, in Decibels
Post-treatment Mean in Overall Severity of Voice Quality	up to 5 weeks after baseline	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).
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score	up to 5 weeks after baseline	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).
Post-treatment Mean in Average Subglottal Pressure	up to 5 weeks after baseline	Aerodynamic measure of voice expressed in cmH20
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)	up to 5 weeks after baseline	Measure of pulmonary function expressed as percent predicted value
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)	up to 5 weeks after baseline	Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)	up to 5 weeks after baseline	Acoustic measure of voice quality, expressed as a percentage
Post-treatment Mean in (Habitual) Sound Pressure Level	up to 5 weeks after baseline	Acoustic measure of loudness, in Decibels
Post-treatment Mean in Baseline Bowing Index	up to 5 weeks after baseline	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.
Post-treatment Mean in Aerodynamic Resistance	up to 5 weeks after baseline	Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second
Post-treatment Mean in Average Glottal Airflow	up to 5 weeks after baseline	Aerodynamic measure of voice expressed in Liters/second
Post-treatment Mean in Forced Vital Capacity (FVC)	up to 5 weeks after baseline	Measure of pulmonary function, expressed as a percent predicted value
Post-treatment Mean in Glottal Function Index (GFI) Score	up to 5 weeks after baseline	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).
Post-treatment Mean in Maximum Expiratory Pressure (MEP)	up to 5 weeks after baseline	Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20
Post-Treatment Mean for FEV1/FVC	up to 5 weeks after baseline	Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)	up to 5 weeks after baseline	Indirect measure of respiratory muscle strength, expressed in cmH20

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States