Respiratory Muscle Strength Training in Presbyphonia

NCT03557775 | Completed Results FDA Device

• 1 other identifier: 00064753
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Presbylarynx

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Post-treatment Mean in (Habitual) Sound Pressure Level

  up to 5 weeks after baseline

• Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)

  up to 5 weeks after baseline

• Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)

  up to 5 weeks after baseline

• Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)

  up to 5 weeks after baseline

• Post-treatment Mean in Overall Severity of Voice Quality

  up to 5 weeks after baseline

Other Outcomes (1)

• Voice-Vibratory Assessment With Laryngeal Imaging

  up to 5 weeks after baseline

Study Arms (3)

Inspiratory Muscle Strength Training

EXPERIMENTAL

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); Behavioral: Voice Exercises

Expiratory Muscle Strength Training

EXPERIMENTAL

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.

Device: Expiratory Muscle Strength Training (EMST); Behavioral: Voice Exercises

Voice Exercises

ACTIVE COMPARATOR

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

Interventions

Inspiratory Muscle Strength Training (IMST) DEVICE

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.

Also known as: Inspiratory muscle training (IMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), Philips Respironics® Threshold IMT, POWERbreathe® Medic Plus

Inspiratory Muscle Strength Training

Expiratory Muscle Strength Training (EMST) DEVICE

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.

Also known as: Expiratory muscle training (EMT), Respiratory muscle training (RMT), Respiratory muscle strength training (RMST), EMST150®

Expiratory Muscle Strength Training

Voice Exercises BEHAVIORAL

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.

Expiratory Muscle Strength Training; Inspiratory Muscle Strength Training; Voice Exercises

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of South Carolina: lead

Study Sites (1)

Medical University of South Carolina

Charleston, South Carolina, 29403, United States

Location

MeSH Terms

Interventions

Breathing Exercises

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Results Point of Contact

• Title: Dr. Heather Shaw Bonilha
• Organization: Medical University of South Carolina

bonilhah@musc.edu

843-792-2527

Study Officials

• Heather Bonilha, PhD

  Medical University of South Carolina

  PRINCIPAL INVESTIGATOR

• Maude Desjardins, M.Sc.

  Medical University of South Carolina

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Perceptual ratings of voice quality and of videostroboscopic images of the larynx will be rater by external judges, who will be blinded to the group assignment and to the assessment time (pre or post treatment).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2018
• First Posted: June 15, 2018
• Study Start: June 15, 2018
• Primary Completion: June 25, 2019
• Study Completion: July 16, 2019
• Last Updated: September 7, 2020
• Results First Posted: September 7, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)