Trial Outcomes & Findings for Respiratory Muscle Strength in Patients With NMD (NCT NCT01555905)

NCT ID: NCT01555905

Last Updated: 2023-05-16

Results Overview

The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.

• Recruitment status: TERMINATED
• Study phase: NA
• Target enrollment: 17 participants
• Primary outcome timeframe: Baseline (pre-IMST) and 3 months (post-IMST)
• Results posted on: 2023-05-16

Participant Flow

Participant milestones

Measure	Exercise Threshold PEP or IMT device Phillips-Respironics Threshold PEP or IMT device Phillips-Respironics: The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
Overall Study STARTED	17
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Respiratory Muscle Strength in Patients With NMD

Baseline characteristics by cohort

Measure	Exercise n=17 Participants Threshold PEP or IMT device Phillips-Respironics Threshold PEP or IMT device Phillips-Respironics: The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
Age, Categorical <=18 years	9 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	24 years n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	16 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	17 participants n=5 Participants
Maximal Inspiratory Pressure	37.3 cm H2O n=5 Participants

PRIMARY outcome

Timeframe: Baseline (pre-IMST) and 3 months (post-IMST)

The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.

Outcome measures

Measure	Exercise n=7 Participants Threshold PEP or IMT device Phillips-Respironics Threshold PEP or IMT device Phillips-Respironics: The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.
Maximal Inspiratory Pressure Pre	33.7 cm H2O Interval 9.8 to 68.0
Maximal Inspiratory Pressure Post	38.0 cm H2O Interval 12.8 to 65.0

Adverse Events

Exercise

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure

Exercise n=17 participants at risk Threshold PEP or IMT device Phillips-Respironics Threshold PEP or IMT device Phillips-Respironics: The subject will be instructed to take 8-15 deep, forceful breaths through the Threshold device, followed by at least 3 minutes of rest. The process will be repeated 3 more times for a total of 4 sets of 8-15 breaths. IMST will be completed three to five days per week, based upon the subject's daily baseline level of fatigue.

Musculoskeletal and connective tissue disorders Muscle Soreness

5.9% 1/17 • Number of events 1 • 12 weeks

Additional Information

D. Barbara Smith

University of Florida

Phone: 3522945315

Email: bksmith@ufl.edu

Results disclosure agreements

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