Trial Outcomes & Findings for Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy (NCT NCT03696576)
NCT ID: NCT03696576
Last Updated: 2021-08-30
Results Overview
The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.
TERMINATED
NA
24 participants
At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)
2021-08-30
Participant Flow
Participants were recruited for the study from September 2018 until March 2020.
Participant milestones
| Measure |
PhoRTE
This group will undergo standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Overall Study
STARTED
|
13
|
11
|
|
Overall Study
COMPLETED
|
10
|
6
|
|
Overall Study
NOT COMPLETED
|
3
|
5
|
Reasons for withdrawal
| Measure |
PhoRTE
This group will undergo standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Overall Study
Soreness of throat after therapy
|
1
|
1
|
|
Overall Study
Lost to Follow-up
|
2
|
4
|
Baseline Characteristics
Expiratory Muscle Strength Training and Phonation Resistance Training Exercises For Elderly Patients With Vocal Fold Atrophy
Baseline characteristics by cohort
| Measure |
PhoRTE
n=13 Participants
This group will undergo standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group will undergo standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
72.10 years
STANDARD_DEVIATION 7.91 • n=5 Participants
|
75.22 years
STANDARD_DEVIATION 8.12 • n=7 Participants
|
73.53 years
STANDARD_DEVIATION 7.99 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
4 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
22 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 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
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
13 participants
n=5 Participants
|
11 participants
n=7 Participants
|
24 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At each study visit through study completion; Time 0 (therapy visit 1-Baseline), follow-up week 1 (therapy visit 2), follow-up week 2 (therapy visit 3),follow-up week 3 (therapy visit 4), follow-up week 5 (follow up visit)Population: Number of participants analyzed is different in each time point, due to difficulties bringing participants into the clinic because of COVID-19.
The Voice Handicap Index-10 (VHI-10) is a validated assessment instrument that quantifies patient perceptions of his or her own voice handicap. A lower score on the VHI-10 indicates perception of a lesser voice handicap than a high score. Scores range from 0 to 40.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Voice Handicap Index-10 (VHI-10) Score
Baseline
|
15.80 score on a scale
Standard Error 6.94
|
17.45 score on a scale
Standard Error 8.55
|
|
Voice Handicap Index-10 (VHI-10) Score
Follow up-week 1
|
18.85 score on a scale
Standard Error 9.5
|
20.54 score on a scale
Standard Error 10.53
|
|
Voice Handicap Index-10 (VHI-10) Score
Follow up-week 2
|
17.00 score on a scale
Standard Error 9.86
|
17.00 score on a scale
Standard Error 12.22
|
|
Voice Handicap Index-10 (VHI-10) Score
Follow up-week 3
|
14.09 score on a scale
Standard Error 9.76
|
15.67 score on a scale
Standard Error 11.94
|
|
Voice Handicap Index-10 (VHI-10) Score
Follow up-week 4
|
12.00 score on a scale
Standard Error 11.07
|
10.17 score on a scale
Standard Error 6.97
|
|
Voice Handicap Index-10 (VHI-10) Score
Follow up-week 5
|
13.3 score on a scale
Standard Error 10.86
|
10.50 score on a scale
Standard Error 9.69
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (Follow up - week 5)Population: All participants were assessed for this outcome measure. 13 participants in the PhoRTE arm and 11 participants in the PhoRTE + EMST arm at baseline and follow up.
The Aging Voice Index (AVI) is a validated instrument that measures quality of life in older adults with voice disorders. A higher score indicates worse quality of life. Scores range from 0 to 92.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
AVI Score at Baseline and Follow up (5 Weeks)
Baseline
|
41.54 score on a scale
Standard Error 6.19
|
43.64 score on a scale
Standard Error 6.73
|
|
AVI Score at Baseline and Follow up (5 Weeks)
Follow Up
|
23.13 score on a scale
Standard Error 6.72
|
27.36 score on a scale
Standard Error 8.23
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Maximum Expiratory Pressure (MEP) was measured using a handheld manometer (Micro Direct Respiratory Pressure Meter, MicroRPM, Med-Electronics, Beltsville, MD, United States) at baseline and after 5 weeks of therapy. Participants were instructed to blow with maximum force into the MicroRPM device over 10 trials, and the participant's best three trials were used to calculate their average MEP.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Maximum Expiratory Pressure (MEP)
Baseline
|
43.08 cm H2O
Standard Error 7.85
|
49.18 cm H2O
Standard Error 8.20
|
|
Maximum Expiratory Pressure (MEP)
Follow Up
|
51.32 cm H2O
Standard Error 8.83
|
81.81 cm H2O
Standard Error 9.94
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Aerodynamic measures were collected and analyzed via the Phonatory Aerodynamic System 6600 (PAS; PENTAX Medical, Montvale, NJ, United States) using the first four sentences of the Rainbow Passage. Aerodynamic measures included mean airflow during voicing and number of breaths taken. The PAS captured phonatory aerodynamic functioning using a pneumotach coupled to a facemask, with external microphone. During speech, expired air flows through the pneumotach, which consists of a stainless-steel mesh screen with pressure transducers on either side. The system calculates the pressure difference across the screen to determine airflow rate. The microphone is positioned at the end of the pneumotach and internally calibrated per system specifications to represent a mouth-to-microphone distance of 15 cm. The participant sat with the facemask held snugly over their nose and mouth while they read the first fou
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Phonatory Airflow in Speech at Baseline and 5 Weeks
Baseline
|
0.29 Liters/second
Standard Error 0.05
|
0.18 Liters/second
Standard Error 0.06
|
|
Phonatory Airflow in Speech at Baseline and 5 Weeks
Follow Up
|
0.13 Liters/second
Standard Error 0.07
|
0.12 Liters/second
Standard Error 0.08
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Aerodynamic measurement: mean number of breaths in reading of a standard passage (The Rainbow Passage).
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Number of Breaths at Baseline and Follow up (5 Weeks)
Baseline
|
7.17 number of breaths
Standard Error 0.96
|
6.59 number of breaths
Standard Error 1.13
|
|
Number of Breaths at Baseline and Follow up (5 Weeks)
Follow Up
|
7.36 number of breaths
Standard Error 1
|
5.52 number of breaths
Standard Error 1.29
|
SECONDARY outcome
Timeframe: Baseline (At initial therapy visit) and final follow up-visit (week 5)Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Baseline
|
26.05 score on a scale
Standard Error 7.15
|
28.85 score on a scale
Standard Error 7.84
|
|
Mean Cepstral Spectral Index of Dysphonia (CSID) Measurements While Reading Functional Phrases at Baseline and 5 Weeks
Follow Up
|
12.08 score on a scale
Standard Error 8.57
|
20.7 score on a scale
Standard Error 9.94
|
SECONDARY outcome
Timeframe: Baseline (At initial therapy visit) and final follow up-visit (week 5)Cepstral Spectral Index of Dysphonia (CSID) is a multifactorial estimate of dysphonia severity that correlates with an auditory perceptual rating of overall voice severity using a 0-100 visual analog scale. Components of the algorithm include the cepstral peak prominence and its standard deviation, the low to high spectral ratio and its standard deviation. Typically, CSID limits are 0-100, but very severe voices may exceed 100, and very periodic, normal voices may be less than 0.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Baseline
|
33.93 score on a scale
Standard Error 8.02
|
42.9 score on a scale
Standard Error 8.79
|
|
Cepstral Spectral Index of Dysphonia (CSID) Measurements at Baseline and 5 Weeks
Follow Up
|
13.08 score on a scale
Standard Error 10.39
|
41.56 score on a scale
Standard Error 12.27
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Aerodynamic measurement; mean duration to complete the reading of a standard passage (The Rainbow Passage).
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Baseline
|
27.23 seconds
Standard Error 1.54
|
28.56 seconds
Standard Error 1.61
|
|
Duration of Standard Reading Passage at Baseline and Follow up (5 Weeks)
Follow up
|
25.31 seconds
Standard Error 1.84
|
24.93 seconds
Standard Error 2.11
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (after week 5)Acoustic measurement: Cepstral Peak Prominence and its standard deviation while reading functional phrases.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Baseline
|
8.05 dB
Standard Error 0.98
|
7.13 dB
Standard Error 1.07
|
|
Cepstral Peak Prominence at Baseline and 5 Weeks Follow up
Follow Up
|
11.32 dB
Standard Error 1.27
|
7.68 dB
Standard Error 1.50
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Acoustic measurement: CPP F0 while reading functional phrases.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Baseline
|
166.21 Hz
Standard Error 14.51
|
167.04 Hz
Standard Error 15.9
|
|
Cepstral Peak Prominence (CPP) Fundamental Frequency (F0) at Baseline and Follow up (5 Weeks)
Follow Up
|
160.97 Hz
Standard Error 15.81
|
178.09 Hz
Standard Error 17.86
|
SECONDARY outcome
Timeframe: At initial therapy visit (Baseline) and final follow up-visit (week 5)Population: All participants were assessed for this outcome measure. 13 participants in the PhoRTE arm and 11 participants in the PhoRTE + EMST arm, at baseline and follow up.
Aerodynamic measurement: mean F0 in reading of a standard passage (The Rainbow Passage).
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Baseline
|
166.31 Hz
Standard Error 8.66
|
152.78 Hz
Standard Error 9.04
|
|
Mean Fundamental Frequency in Sentence at Baseline and at 5 Weeks
Follow Up
|
177.09 Hz
Standard Error 10.15
|
156.81 Hz
Standard Error 11.55
|
SECONDARY outcome
Timeframe: At initial therapy visit (baseline) and final follow up-visit (week 5)Population: All participants were assessed for this outcome measure. 13 participants in the PhoRTE arm and 11 participants in the PhoRTE + EMST arm, at baseline and follow up.
Acoustic measurement: mean vocal intensity in dB SPL while reading functional phrases.
Outcome measures
| Measure |
PhoRTE
n=13 Participants
This group received standard PhoRTE therapy.
PhoRTE: Completing of PhoRTE voice therapy.
|
PhoRTE + EMST
n=11 Participants
This group received standard PhoRTE therapy with the addition of expiratory muscle strength training using the EMST device.
EMST: Training of the respiratory system muscles using the EMST device.
PhoRTE: Completing of PhoRTE voice therapy.
|
|---|---|---|
|
Vocal Intensity at Baseline and Follow up
Follow Up
|
78.06 dB SPL
Standard Error 1.95
|
73.56 dB SPL
Standard Error 2.31
|
|
Vocal Intensity at Baseline and Follow up
Baseline
|
74.22 dB SPL
Standard Error 1.49
|
76.48 dB SPL
Standard Error 1.56
|
SECONDARY outcome
Timeframe: At initial therapy visit and final follow up-visit, after week 5Population: Auditory perceptual measurements of overall voice severity were not collected, thus not analyzed, due to having to convert to tele-health due to COVID-19 pandemic.
Overall voice severity determined by Consensus Auditory Perceptual Evaluation - Voice (CAPE-V) score provided by blinded raters. The visual analog scale for overall voice severity used. Minimum score = 0, Maximum score = 100. Higher values indicate worse voice.
Outcome measures
Outcome data not reported
Adverse Events
PhoRTE
PhoRTE + EMST
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place