The purpose of this study is to help understand how training breathing muscles will impact balance, blood pressure, and quality of life of participants with spinal cord injury.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
18
IMT is a breathing training technique customized to participant's breathing capacity. Using a handheld electronic manometer (Pro2Fit from Smithfield), a study personnel will initiate training at 40-60% maximal inspiratory pressure. Adjustments will be customized to where the participant reports a difficulty of training between 4-6 out of 10. Training sessions will be performed about 30 minutes a day for 28 consecutive days.
The Miami Project to Cure Paralysis
Miami, Florida, United States
Percent Compliance of Training Sessions
Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Time frame: 4 weeks
Percent Compliance of Training Minutes
Feasibility of the IMT protocol will also be reported as the percentage of completed total time out of the 840 minutes total expected session minutes(30 minutes daily for 28 days).
Time frame: 4 weeks
Maximal Inspiratory Pressure (MIP)
MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Time frame: Week 12
Sustained Maximal Inspiratory Pressure (SMIP)
SMIP measured in pressure-time units (PTU) will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Time frame: Week 12
Standard deviation of normal R-R intervals (SDNN)
SDNN, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Time frame: Week 12
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
rMSSD, measured in milliseconds, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Time frame: Week 12
Systolic Blood Pressure (SBP)
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
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Time frame: Week 12
Functional Seated Balance
Functional Seated Balance will be measured using the Function in Sitting Test for SCI (FIST-SCI). FIST-SCI consist of 14 different standardized seated balance tasks and scored on a 5-point ordinal scale from 0-4. A higher score indicates increased independence.
Time frame: Week 12
Quality of Life (QoL)
QoL will be measured using the Quality of Life Index, SCI version (QOLI-SCI). QOLI-SCI is a set of two 37-items questionnaire with total scores ranging from 74 to 444 with the higher score indicating increased quality of life.
Time frame: Week 12
Independence
Independence will be measured using the Spinal Cord Independence Measured (SCIM). SCIM has a total score ranging from 0-100 with the higher score indicating increased independence.
Time frame: Week 12
Inspiratory Duration (ID)
ID measured in seconds will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Time frame: Week 12
Forced Vital Capacity
FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Time frame: Week 12
Forced Expiratory Volume in one Second (FEV1)
FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Time frame: Week 12
Peak Expiratory Flow (PEF)
PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Time frame: Week 12
Maximal Expiratory Pressure (MEP)
MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Time frame: Week 12
Heart Rate Variability (HRV) Frequency
Low Frequency (LF) and High Frequency (HF) Power, reported in percentage, will be derived from signals obtained by a Polar monitor (with elastic chest strap sensor) and analyzed using Kubios Heart Rate Variability (HRV) Analysis Software.
Time frame: Week 12
Diastolic Blood Pressure (DBP)
Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Time frame: Week 12