Trial Outcomes & Findings for Respiratory Muscle Strength Training in Presbyphonia (NCT NCT03557775)

NCT ID: NCT03557775

Last Updated: 2020-09-07

Results Overview

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 )

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 22 participants
• Primary outcome timeframe: up to 5 weeks after baseline
• Results posted on: 2020-09-07

Participant Flow

We had 22 subjects enrolled, however one did not meet the screening requirements and was not further included in the study (and therefore was not randomized to an intervention group). Another participant withdrew before being randomized to an intervention group. In total, 20 participants were randomized to the intervention groups.

Participant milestones

Measure	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).	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).	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. 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.
Overall Study STARTED	5	7	8
Overall Study COMPLETED	4	4	4
Overall Study NOT COMPLETED	1	3	4

Reasons for withdrawal

Measure	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).	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).	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. 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.
Overall Study Withdrawal by Subject	1	2	4
Overall Study Physician Decision	0	1	0

Baseline Characteristics

Respiratory Muscle Strength Training in Presbyphonia

Baseline characteristics by cohort

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.	Total n=12 Participants Total of all reporting groups
Age, Continuous	67.50 years STANDARD_DEVIATION 8.74 • n=5 Participants	70.50 years STANDARD_DEVIATION 7.23 • n=7 Participants	77.50 years STANDARD_DEVIATION 4.66 • n=5 Participants	71.83 years STANDARD_DEVIATION 7.76 • n=4 Participants
Sex: Female, Male Female	3 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants	5 Participants n=4 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants	7 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	4 Participants n=5 Participants	12 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	4 participants n=5 Participants	4 participants n=7 Participants	4 participants n=5 Participants	12 participants n=4 Participants
Reflux Symptom Index score	19.75 Score on a scale STANDARD_DEVIATION 3.59 • n=5 Participants	14.50 Score on a scale STANDARD_DEVIATION 5.80 • n=7 Participants	14.25 Score on a scale STANDARD_DEVIATION 8.54 • n=5 Participants	16.17 Score on a scale STANDARD_DEVIATION 6.29 • n=4 Participants
Voice Handicap Index score	24.00 Score on a scale STANDARD_DEVIATION 6.06 • n=5 Participants	13.75 Score on a scale STANDARD_DEVIATION 7.93 • n=7 Participants	21.25 Score on a scale STANDARD_DEVIATION 6.19 • n=5 Participants	19.67 Score on a scale STANDARD_DEVIATION 7.62 • n=4 Participants

PRIMARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

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 )

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-Treatment Mean in Voice Handicap Index Score	15.00 score on a scale Standard Deviation 4.97	15.75 score on a scale Standard Deviation 8.77	18.50 score on a scale Standard Deviation 10.66

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Acoustic measure of loudness, in Decibels

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in (Habitual) Sound Pressure Level	73.18 Decibels (dB) Standard Deviation 5.29	70.73 Decibels (dB) Standard Deviation 1.65	74.75 Decibels (dB) Standard Deviation 2.60

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Acoustic measure of voice quality, in Decibels

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)	18.03 Decibels (dB) Standard Deviation 1.83	16.74 Decibels (dB) Standard Deviation 0.52	17.86 Decibels (dB) Standard Deviation 1.06

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)	0.13 ratio Standard Deviation 0.02	0.16 ratio Standard Deviation 0.06	0.12 ratio Standard Deviation 0.01

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Acoustic measure of voice quality, expressed as a percentage

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)	2.91 percentage Standard Deviation 1.04	4.25 percentage Standard Deviation 2.56	3.05 percentage Standard Deviation 0.60

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

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).

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Overall Severity of Voice Quality	21.00 units on a scale Standard Deviation 10.61	31.25 units on a scale Standard Deviation 28.65	35.00 units on a scale Standard Deviation 17.78

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

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.

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Baseline Bowing Index	9.03 Index Standard Deviation 3.35	5.76 Index Standard Deviation 0.96	8.97 Index Standard Deviation 1.05

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

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).

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score	24.00 score on a scale Standard Deviation 1.00	19.50 score on a scale Standard Deviation 7.14	14.75 score on a scale Standard Deviation 7.27

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

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).

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Glottal Function Index (GFI) Score	9.75 score on a scale Standard Deviation 4.03	8.75 score on a scale Standard Deviation 4.27	8.75 score on a scale Standard Deviation 5.50

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Aerodynamic measure of voice expressed in Liters/second

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Average Glottal Airflow	0.10 liters/second Standard Deviation 0.06	0.27 liters/second Standard Deviation 0.06	0.18 liters/second Standard Deviation 0.08

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Aerodynamic measure of voice expressed in cmH20

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Average Subglottal Pressure	6.37 cmH20 Standard Deviation 2.33	6.47 cmH20 Standard Deviation 1.96	5.99 cmH20 Standard Deviation 0.32

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Aerodynamic Resistance	63.43 cmH20/liters/second Standard Deviation 17.07	21.25 cmH20/liters/second Standard Deviation 7.71	37.11 cmH20/liters/second Standard Deviation 15.11

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Maximum Expiratory Pressure (MEP)	121.00 cmH20 Standard Deviation 69.29	176.25 cmH20 Standard Deviation 25.85	131.00 cmH20 Standard Deviation 40.60

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Indirect measure of respiratory muscle strength, expressed in cmH20

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)	98.75 cmH20 Standard Deviation 43.49	84.50 cmH20 Standard Deviation 18.91	81.50 cmH20 Standard Deviation 9.82

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Measure of pulmonary function, expressed as a percent predicted value

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Forced Vital Capacity (FVC)	80.75 percentage of predicted value Standard Deviation 20.87	80.75 percentage of predicted value Standard Deviation 22.81	94.00 percentage of predicted value Standard Deviation 10.46

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Measure of pulmonary function expressed as percent predicted value

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)	75.75 percentage of predicted value Standard Deviation 20.76	73.00 percentage of predicted value Standard Deviation 32.44	94.00 percentage of predicted value Standard Deviation 8.91

SECONDARY outcome

Timeframe: up to 5 weeks after baseline

Population: Per protocol

Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)

Outcome measures

Measure	Inspiratory Muscle Strength Training n=4 Participants The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=4 Participants The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=4 Participants 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.
Post-Treatment Mean for FEV1/FVC	94.00 percentage of predicted value Standard Deviation 4.69	87.75 percentage of predicted value Standard Deviation 20.12	99.00 percentage of predicted value Standard Deviation 2.94

OTHER_PRE_SPECIFIED outcome

Timeframe: up to 5 weeks after baseline

exploratory measure

Outcome measures

Outcome data not reported

Adverse Events

Inspiratory Muscle Strength Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Expiratory Muscle Strength Training

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Voice Exercises

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Inspiratory Muscle Strength Training n=5 participants at risk The participants in the IMST arm will receive, in addition to standard of care voice therapy, inspiratory muscle strength training (IMST).	Expiratory Muscle Strength Training n=7 participants at risk The participants in the EMST arm will receive, in addition to standard of care voice therapy, expiratory muscle strength training (EMST).	Voice Exercises n=8 participants at risk 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.
Skin and subcutaneous tissue disorders Skin irritation	0.00% 0/5 • 1 year	14.3% 1/7 • Number of events 1 • 1 year	0.00% 0/8 • 1 year
Respiratory, thoracic and mediastinal disorders Transient aching	20.0% 1/5 • Number of events 1 • 1 year	0.00% 0/7 • 1 year	0.00% 0/8 • 1 year

Additional Information

Dr. Heather Shaw Bonilha

Medical University of South Carolina

Phone: 843-792-2527

Email: bonilhah@musc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place