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Trial record 90 of 10381 for:    strength

Respiratory Muscle Strength Training in Presbyphonia

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ClinicalTrials.gov Identifier: NCT03557775
Recruitment Status : Completed
First Posted : June 15, 2018
Last Update Posted : July 30, 2019
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment Phase
Presbylarynx Device: Inspiratory Muscle Strength Training (IMST) Device: Expiratory Muscle Strength Training (EMST) Behavioral: Voice Exercises Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Masking Description: 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).
Primary Purpose: Treatment
Official Title: Respiratory Muscle Strength Training in Presbyphonia
Actual Study Start Date : June 15, 2018
Actual Primary Completion Date : June 25, 2019
Actual Study Completion Date : July 16, 2019

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.

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:
  • Expiratory muscle training (EMT)
  • Respiratory muscle training (RMT)
  • Respiratory muscle strength training (RMST)
  • EMST150®

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.

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.




Primary Outcome Measures :
  1. Change from baseline Voice Handicap Index score [ Time Frame: From baseline to up to 5 weeks ]
    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 :
  1. Change from baseline mean (habitual) sound pressure level [ Time Frame: From baseline to up to 5 weeks ]
    Decibels

  2. Change from baseline smoothed cepstral peak prominence (CPPS) [ Time Frame: From baseline to up to 5 weeks ]
    Decibels

  3. Change from baseline noise-to-harmonic ratio (NHR) [ Time Frame: From baseline to up to 5 weeks ]
    ratio

  4. Change from baseline amplitude perturbation quotient (APQ) [ Time Frame: From baseline to up to 5 weeks ]
    Percentage

  5. Change from baseline overall severity of voice quality [ Time Frame: From baseline to up to 5 weeks ]
    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).

  6. Change from baseline maximum inspiratory pressure (MIP) [ Time Frame: From baseline to up to 5 weeks ]
    cmH20

  7. Change from baseline maximum expiratory pressure (MEP) [ Time Frame: From baseline to up to 5 weeks ]
    cmH20

  8. Change from baseline bowing index [ Time Frame: From baseline to up to 5 weeks ]
    Length of vocal fold/distance from edge x100

  9. Change from baseline Glottal Function Index (GFI) score [ Time Frame: From baseline to up to 5 weeks ]
    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).

  10. Change from baseline mean glottal airflow [ Time Frame: From baseline to up to 5 weeks ]
    liters/second

  11. Change from baseline average subglottal pressure [ Time Frame: From baseline to up to 5 weeks ]
    cmH20

  12. Change from baseline laryngeal resistance [ Time Frame: From baseline to up to 5 weeks ]
    cmH20/liters/second

  13. Change from baseline forced vital capacity (FVC) [ Time Frame: From baseline to up to 5 weeks ]
    raw value (L) and percent predicted value

  14. Change from baseline forced expiratory volume in 1 second (FEV1) [ Time Frame: From baseline to up to 5 weeks ]
    raw value (L/s) and percent predicted value

  15. Change from baseline FVC/FEV1 [ Time Frame: From baseline to up to 5 weeks ]
    raw value and percent predicted value

  16. Change from baseline Communicative Participation Item Bank (CPIB) score [ Time Frame: From baseline to up to 5 weeks ]
    Ordinal scale measuring the impact of the communication disorder on various situations. A higher score is indicative of a more functional communication (maximum score is 30).


Other Outcome Measures:
  1. Change from baseline voice-Vibratory Assessment with Laryngeal Imaging [ Time Frame: From baseline to up to 5 weeks ]
    exploratory measure



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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03557775


Locations
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United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29403
Sponsors and Collaborators
Medical University of South Carolina
Investigators
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Principal Investigator: Heather Bonilha, PhD Medical University of South Carolina
Study Director: Maude Desjardins, M.Sc. Medical University of South Carolina

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Responsible Party: Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT03557775     History of Changes
Other Study ID Numbers: 00064753
First Posted: June 15, 2018    Key Record Dates
Last Update Posted: July 30, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No