Respiratory Muscle Strength Training in Presbyphonia

Medical University of South Carolina (MUSC)

Status: Completed

Conditions: Presbylarynx

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03557775

00064753

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 50+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

22 participants in 3 patient groups

Inspiratory Muscle Strength Training

Experimental group

Description:

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.

Treatment:

Behavioral: Voice Exercises

Device: Inspiratory Muscle Strength Training (IMST)

Expiratory Muscle Strength Training

Experimental group

Description:

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.

Treatment:

Behavioral: Voice Exercises

Device: Expiratory Muscle Strength Training (EMST)

Voice Exercises

Active Comparator group

Description:

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.

Treatment:

Behavioral: Voice Exercises