Trial Outcomes & Findings for Novel Management of Airway Protection in Parkinson's Disease: A Clinical Trial (NCT NCT02927691)
NCT ID: NCT02927691
Last Updated: 2023-12-22
Results Overview
Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
65 participants
Primary outcome timeframe
Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)
Results posted on
2023-12-22
Participant Flow
Participant milestones
| Measure |
Expiratory Muscle Strength Training (EMST)
Participants will receive Expiratory Muscle Strength Training. Expiratory Muscle Strength Training is a device driven strength training paradigm for respiratory muscles. Twenty-five repetitions per day (5 sets of 5 repetitions) will be completed five days per week. Once per week with a clinician.
|
Sensorimotor Training for Airway Protection (smTAP)
Participants will be randomized to receive Sensorimotor Training for Airway Protection. Sensorimotor Training for Airway Protection is a skill-based paradigm for improving airway protective function. Twenty-five repetitions per day (5 sets of 5 repetitions) will be completed five days per week. Once per week with a clinician.
|
|---|---|---|
|
Overall Study
STARTED
|
34
|
31
|
|
Overall Study
COMPLETED
|
30
|
28
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Expiratory Muscle Strength Training (EMST)
n=34 Participants
Participants will receive Expiratory Muscle Strength Training (EMST)
|
Sensorimotor Training for Airway Protection (smTAP)
n=31 Participants
Participants will receive Sensorimotor training for airway protection (smTAP)
|
Total
n=65 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=34 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=65 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=34 Participants
|
9 Participants
n=31 Participants
|
18 Participants
n=65 Participants
|
|
Age, Categorical
>=65 years
|
25 Participants
n=34 Participants
|
22 Participants
n=31 Participants
|
47 Participants
n=65 Participants
|
|
Age, Continuous
|
70.5 years
n=34 Participants
|
69.1 years
n=31 Participants
|
70 years
n=65 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=34 Participants
|
9 Participants
n=31 Participants
|
22 Participants
n=65 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=34 Participants
|
22 Participants
n=31 Participants
|
43 Participants
n=65 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
United States
|
34 participants
n=34 Participants
|
31 participants
n=31 Participants
|
65 participants
n=65 Participants
|
|
Maximum Expiratory Pressure
|
97 cm H20
n=34 Participants
|
112 cm H20
n=31 Participants
|
102 cm H20
n=65 Participants
|
|
Voluntary Cough Peak Flow
|
2.98 l/s
n=34 Participants
|
3.05 l/s
n=31 Participants
|
3.04 l/s
n=65 Participants
|
PRIMARY outcome
Timeframe: Pre to Post treatment (Pre: Baseline and Post Treatment: 5 weeks)Peak expiratory flow rate (PEFR) was measured before (baseline) and after 5 weeks of treatment with EMST and smTAP.
Outcome measures
| Measure |
EMST
n=34 Participants
Participants will receive EMST
|
smTAP
n=31 Participants
Participants will receive smTAP
|
|---|---|---|
|
Change in Voluntary Cough Peak Flow
|
0.17 l/s
Interval -2.32 to 3.85
|
0.51 l/s
Interval -1.07 to 5.82
|
Adverse Events
EMST
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
smTAP
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
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