Respiratory Muscle Strength Training in Presbyphonia

NCT ID: NCT03557775

Last Updated: 2020-09-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-06-15
• Study Completion Date: 2019-07-16

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

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Inspiratory Muscle Strength Training (IMST)

Intervention Type: 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.

Voice Exercises

Intervention Type: 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

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.

Group Type: EXPERIMENTAL

Expiratory Muscle Strength Training (EMST)

Intervention Type: 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.

Voice Exercises

Intervention Type: 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.

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.

Group Type: ACTIVE_COMPARATOR

Voice Exercises

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DEVICE

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.

Intervention Type: BEHAVIORAL

Other Intervention Names

Inspiratory muscle training (IMT); Respiratory muscle training (RMT); Respiratory muscle strength training (RMST); Philips Respironics® Threshold IMT; POWERbreathe® Medic Plus; Expiratory muscle training (EMT); Respiratory muscle training (RMT); Respiratory muscle strength training (RMST); EMST150®

Eligibility Criteria

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of South Carolina

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Heather Bonilha, PhD

Role: PRINCIPAL_INVESTIGATOR

Medical University of South Carolina

Maude Desjardins, M.Sc.

Role: STUDY_DIRECTOR

Medical University of South Carolina

Locations

Medical University of South Carolina

Charleston, South Carolina, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

00064753

Identifier Type: -

Identifier Source: org_study_id