Neuromuscular Disease
Conditions
Keywords
Respiratory Muscle Strength
Brief summary
The purpose of this study is to determine if inspiratory muscle strength training (IMST) will impact maximal inspiratory pressure and pulmonary function in patients with neuromuscular disease.
Detailed description
Subjects undergo a 12-week period of inspiratory muscle strength training. Respiratory strength is assessed before and after the training period.
Interventions
DEVICEThreshold 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.
Sponsors
University of Florida
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Months to 65 Years
Healthy volunteers
No
Inclusion criteria
* Confirmed diagnosis of neuromuscular disease * Clinical evidence of impaired pulmonary function
Exclusion criteria
* Above or below age range * No clinical evidence of impaired pulmonary function * No diagnosis of a neuromusuclar disease * Presence of an acute illness at time of study * Participating in other research studies involving investigational drugs * Diagnosis of a primary pulmonary disease * Use of tobacco products
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maximal Inspiratory Pressure | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 17 |
| Total | 17 |
Baseline characteristics
| Characteristic | Exercise |
|---|---|
| Age, Categorical <=18 years | 9 Participants |
| Age, Categorical >=65 years | 0 Participants |
| Age, Categorical Between 18 and 65 years | 8 Participants |
| Age, Continuous | 24 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 14 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Maximal Inspiratory Pressure | 37.3 cm H2O |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 16 Participants |
| Region of Enrollment United States | 17 participants |
| Sex: Female, Male Female | 11 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 17 |
| other Total, other adverse events | 1 / 17 |
| serious Total, serious adverse events | 0 / 17 |
Outcome results
Primary
Maximal Inspiratory Pressure
The primary endpoints for inspiratory muscle training efficacy will be maximal inspiratory pressure tests, a measure of respiratory strength.
Time frame: Baseline (pre-IMST) and 3 months (post-IMST)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Exercise | Maximal Inspiratory Pressure | Pre | 33.7 cm H2O |
| Exercise | Maximal Inspiratory Pressure | Post | 38.0 cm H2O |