Presbylarynx
Conditions
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.
Interventions
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.
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.
BEHAVIORALVoice 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.
Sponsors
Medical University of South Carolina
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
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).
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Treatment Mean in Voice Handicap Index Score | up to 5 weeks after baseline | 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
| Measure | Time frame | Description |
|---|---|---|
| Post-treatment Mean in (Habitual) Sound Pressure Level | up to 5 weeks after baseline | Acoustic measure of loudness, in Decibels |
| Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) | up to 5 weeks after baseline | Acoustic measure of voice quality, in Decibels |
| Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) | up to 5 weeks after baseline | Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal. |
| Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | up to 5 weeks after baseline | Acoustic measure of voice quality, expressed as a percentage |
| Post-treatment Mean in Overall Severity of Voice Quality | up to 5 weeks after baseline | 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). |
| Post-treatment Mean in Baseline Bowing Index | up to 5 weeks after baseline | 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. |
| Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score | up to 5 weeks after baseline | 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). |
| Post-treatment Mean in Glottal Function Index (GFI) Score | up to 5 weeks after baseline | 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). |
| Post-treatment Mean in Average Subglottal Pressure | up to 5 weeks after baseline | Aerodynamic measure of voice expressed in cmH20 |
| Post-treatment Mean in Aerodynamic Resistance | up to 5 weeks after baseline | Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second |
| Post-treatment Mean in Maximum Expiratory Pressure (MEP) | up to 5 weeks after baseline | Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20 |
| Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | up to 5 weeks after baseline | Indirect measure of respiratory muscle strength, expressed in cmH20 |
| Post-treatment Mean in Forced Vital Capacity (FVC) | up to 5 weeks after baseline | Measure of pulmonary function, expressed as a percent predicted value |
| Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) | up to 5 weeks after baseline | Measure of pulmonary function expressed as percent predicted value |
| Post-Treatment Mean for FEV1/FVC | up to 5 weeks after baseline | Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity) |
| Post-treatment Mean in Average Glottal Airflow | up to 5 weeks after baseline | Aerodynamic measure of voice expressed in Liters/second |
Other
| Measure | Time frame | Description |
|---|---|---|
| Voice-Vibratory Assessment With Laryngeal Imaging | up to 5 weeks after baseline | exploratory measure |
Countries
United States
Participant flow
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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). | 4 |
| 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). | 4 |
| 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. | 4 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 1 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 2 | 4 |
Baseline characteristics
| Characteristic | Inspiratory Muscle Strength Training | Expiratory Muscle Strength Training | Voice Exercises | Total |
|---|---|---|---|---|
| Age, Continuous | 67.50 years STANDARD_DEVIATION 8.74 | 70.50 years STANDARD_DEVIATION 7.23 | 77.50 years STANDARD_DEVIATION 4.66 | 71.83 years STANDARD_DEVIATION 7.76 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 4 Participants | 4 Participants | 4 Participants | 12 Participants |
| Reflux Symptom Index score | 19.75 Score on a scale STANDARD_DEVIATION 3.59 | 14.50 Score on a scale STANDARD_DEVIATION 5.8 | 14.25 Score on a scale STANDARD_DEVIATION 8.54 | 16.17 Score on a scale STANDARD_DEVIATION 6.29 |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants | 12 participants |
| Sex: Female, Male Female | 3 Participants | 1 Participants | 1 Participants | 5 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 3 Participants | 7 Participants |
| Voice Handicap Index score | 24.00 Score on a scale STANDARD_DEVIATION 6.06 | 13.75 Score on a scale STANDARD_DEVIATION 7.93 | 21.25 Score on a scale STANDARD_DEVIATION 6.19 | 19.67 Score on a scale STANDARD_DEVIATION 7.62 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 7 | 0 / 8 |
| other Total, other adverse events | 1 / 5 | 1 / 7 | 0 / 8 |
| serious Total, serious adverse events | 0 / 5 | 0 / 7 | 0 / 8 |
Outcome results
Primary
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 )
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-Treatment Mean in Voice Handicap Index Score | 15.00 score on a scale | Standard Deviation 4.97 |
| Expiratory Muscle Strength Training | Post-Treatment Mean in Voice Handicap Index Score | 15.75 score on a scale | Standard Deviation 8.77 |
| Voice Exercises | Post-Treatment Mean in Voice Handicap Index Score | 18.50 score on a scale | Standard Deviation 10.66 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.041ANOVA
Secondary
Post-Treatment Mean for FEV1/FVC
Pulmonary function measure expressed as percent predicted value (ratio between forced expiratory volume in one second and forced vital capacity)
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-Treatment Mean for FEV1/FVC | 94.00 percentage of predicted value | Standard Deviation 4.69 |
| Expiratory Muscle Strength Training | Post-Treatment Mean for FEV1/FVC | 87.75 percentage of predicted value | Standard Deviation 20.12 |
| Voice Exercises | Post-Treatment Mean for FEV1/FVC | 99.00 percentage of predicted value | Standard Deviation 2.94 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.988ANOVA
Secondary
Post-treatment Mean in Aerodynamic Resistance
Aerodynamic measure (subglottal pressure divided by mean flow rate), expressed as cmH20/liters/second
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Aerodynamic Resistance | 63.43 cmH20/liters/second | Standard Deviation 17.07 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Aerodynamic Resistance | 21.25 cmH20/liters/second | Standard Deviation 7.71 |
| Voice Exercises | Post-treatment Mean in Aerodynamic Resistance | 37.11 cmH20/liters/second | Standard Deviation 15.11 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.721ANOVA
Secondary
Post-treatment Mean in Average Glottal Airflow
Aerodynamic measure of voice expressed in Liters/second
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Average Glottal Airflow | 0.10 liters/second | Standard Deviation 0.06 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Average Glottal Airflow | 0.27 liters/second | Standard Deviation 0.06 |
| Voice Exercises | Post-treatment Mean in Average Glottal Airflow | 0.18 liters/second | Standard Deviation 0.08 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.663ANOVA
Secondary
Post-treatment Mean in Average Subglottal Pressure
Aerodynamic measure of voice expressed in cmH20
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Average Subglottal Pressure | 6.37 cmH20 | Standard Deviation 2.33 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Average Subglottal Pressure | 6.47 cmH20 | Standard Deviation 1.96 |
| Voice Exercises | Post-treatment Mean in Average Subglottal Pressure | 5.99 cmH20 | Standard Deviation 0.32 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.026ANOVA
Secondary
Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ)
Acoustic measure of voice quality, expressed as a percentage
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | 2.91 percentage | Standard Deviation 1.04 |
| Expiratory Muscle Strength Training | Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | 4.25 percentage | Standard Deviation 2.56 |
| Voice Exercises | Post-Treatment Mean in Baseline Amplitude Perturbation Quotient (APQ) | 3.05 percentage | Standard Deviation 0.6 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.198ANOVA
Secondary
Post-treatment Mean in Baseline Bowing Index
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.
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Baseline Bowing Index | 9.03 Index | Standard Deviation 3.35 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Baseline Bowing Index | 5.76 Index | Standard Deviation 0.96 |
| Voice Exercises | Post-treatment Mean in Baseline Bowing Index | 8.97 Index | Standard Deviation 1.05 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.296ANOVA
Secondary
Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR)
Acoustic measure of voice quality, expressed as a ratio of noise to harmonics in the signal.
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) | 0.13 ratio | Standard Deviation 0.02 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) | 0.16 ratio | Standard Deviation 0.06 |
| Voice Exercises | Post-treatment Mean in Baseline Noise-to-harmonic Ratio (NHR) | 0.12 ratio | Standard Deviation 0.01 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.702ANOVA
Secondary
Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading)
Acoustic measure of voice quality, in Decibels
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) | 18.03 Decibels (dB) | Standard Deviation 1.83 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) | 16.74 Decibels (dB) | Standard Deviation 0.52 |
| Voice Exercises | Post-treatment Mean in Baseline Smoothed Cepstral Peak Prominence (CPPS) (During Reading) | 17.86 Decibels (dB) | Standard Deviation 1.06 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.733ANOVA
Secondary
Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score
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).
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score | 24.00 score on a scale | Standard Deviation 1 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score | 19.50 score on a scale | Standard Deviation 7.14 |
| Voice Exercises | Post-treatment Mean in Communicative Participation Item Bank (CPIB) Score | 14.75 score on a scale | Standard Deviation 7.27 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.04ANOVA
Secondary
Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1)
Measure of pulmonary function expressed as percent predicted value
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) | 75.75 percentage of predicted value | Standard Deviation 20.76 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) | 73.00 percentage of predicted value | Standard Deviation 32.44 |
| Voice Exercises | Post-treatment Mean in Forced Expiratory Volume in 1 Second (FEV1) | 94.00 percentage of predicted value | Standard Deviation 8.91 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.708ANOVA
Secondary
Post-treatment Mean in Forced Vital Capacity (FVC)
Measure of pulmonary function, expressed as a percent predicted value
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Forced Vital Capacity (FVC) | 80.75 percentage of predicted value | Standard Deviation 20.87 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Forced Vital Capacity (FVC) | 80.75 percentage of predicted value | Standard Deviation 22.81 |
| Voice Exercises | Post-treatment Mean in Forced Vital Capacity (FVC) | 94.00 percentage of predicted value | Standard Deviation 10.46 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.715ANOVA
Secondary
Post-treatment Mean in Glottal Function Index (GFI) Score
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).
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Glottal Function Index (GFI) Score | 9.75 score on a scale | Standard Deviation 4.03 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Glottal Function Index (GFI) Score | 8.75 score on a scale | Standard Deviation 4.27 |
| Voice Exercises | Post-treatment Mean in Glottal Function Index (GFI) Score | 8.75 score on a scale | Standard Deviation 5.5 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.887ANOVA
Secondary
Post-treatment Mean in (Habitual) Sound Pressure Level
Acoustic measure of loudness, in Decibels
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in (Habitual) Sound Pressure Level | 73.18 Decibels (dB) | Standard Deviation 5.29 |
| Expiratory Muscle Strength Training | Post-treatment Mean in (Habitual) Sound Pressure Level | 70.73 Decibels (dB) | Standard Deviation 1.65 |
| Voice Exercises | Post-treatment Mean in (Habitual) Sound Pressure Level | 74.75 Decibels (dB) | Standard Deviation 2.6 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.887ANOVA
Secondary
Post-treatment Mean in Maximum Expiratory Pressure (MEP)
Indirect measure of respiratory (expiratory) muscle strength, expressed in cmH20
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Maximum Expiratory Pressure (MEP) | 121.00 cmH20 | Standard Deviation 69.29 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Maximum Expiratory Pressure (MEP) | 176.25 cmH20 | Standard Deviation 25.85 |
| Voice Exercises | Post-treatment Mean in Maximum Expiratory Pressure (MEP) | 131.00 cmH20 | Standard Deviation 40.6 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.408ANOVA
Secondary
Post-treatment Mean in Maximum Inspiratory Pressure (MIP)
Indirect measure of respiratory muscle strength, expressed in cmH20
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | 98.75 cmH20 | Standard Deviation 43.49 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | 84.50 cmH20 | Standard Deviation 18.91 |
| Voice Exercises | Post-treatment Mean in Maximum Inspiratory Pressure (MIP) | 81.50 cmH20 | Standard Deviation 9.82 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.638ANOVA
Secondary
Post-treatment Mean in Overall Severity of Voice Quality
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).
Time frame: up to 5 weeks after baseline
Population: Per protocol
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Inspiratory Muscle Strength Training | Post-treatment Mean in Overall Severity of Voice Quality | 21.00 units on a scale | Standard Deviation 10.61 |
| Expiratory Muscle Strength Training | Post-treatment Mean in Overall Severity of Voice Quality | 31.25 units on a scale | Standard Deviation 28.65 |
| Voice Exercises | Post-treatment Mean in Overall Severity of Voice Quality | 35.00 units on a scale | Standard Deviation 17.78 |
Comparison: Null hypothesis: there will be no significant time by group interaction effect for this variable.p-value: 0.388ANOVA
Other Pre-specified
Voice-Vibratory Assessment With Laryngeal Imaging
exploratory measure
Time frame: up to 5 weeks after baseline