Spinal Cord Injuries
Conditions
Keywords
Breathing, Diaphragm, Balance, Blood Pressure
Brief summary
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.
Interventions
OTHERInspiratory Muscle Training (IMT)
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.
Sponsors
Foundation for Physical Therapy, Inc.
The Craig H. Neilsen Foundation
University of Miami
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Upper/lower/both extremity weakness or paralysis resulting from SCI with ASIA Impairment Scale (AIS) grades A-C who use a wheelchair as primary means of mobility. 2. ≥1 year post-injury 3. Willingness to participate in the study and provide consent.
Exclusion criteria
1. Inability to understand the consent form or consent process 2. Reliance on a mechanical ventilator. 3. Use of Betablockers 4. Inability to travel to The Miami Project for weekly sessions during intervention month 5. Any complication that would limit transfer ability, or compromise supine or sitting tolerance, including but not limited to: * Fracture, dislocation, or malformations affecting supine or sitting tolerance. * Spinal instability. * Pressure ulcers or skin integrity issues on contact surfaces that would prohibit sitting or lying in supine. 6. Individuals who are able to stand independently or with a walker 7. Unresolved deep vein thrombosis (DVT). 8. Hospitalization due to autonomic dysreflexia in the last 3 months. 9. Pregnancy determined by urine testing in sexually active females.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Independence | Week 12 | 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. |
| Maximal Inspiratory Pressure (MIP) | Week 12 | MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop |
| Sustained Maximal Inspiratory Pressure (SMIP) | Week 12 | 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. |
| Standard deviation of normal R-R intervals (SDNN) | Week 12 | 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. |
| Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD) | Week 12 | 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. |
| Systolic Blood Pressure (SBP) | Week 12 | Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor. |
| Functional Seated Balance | Week 12 | 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. |
| Quality of Life (QoL) | Week 12 | 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. |
| Percent Compliance of Training Sessions | 4 weeks | Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days. |
| Percent Compliance of Training Minutes | 4 weeks | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Forced Vital Capacity | Week 12 | FVC, evaluated in liters, will be measured using a handheld digital spirometer device. |
| Forced Expiratory Volume in one Second (FEV1) | Week 12 | FEV1, evaluated in liters, will be measured using a handheld digital spirometer device. |
| Peak Expiratory Flow (PEF) | Week 12 | PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device. |
| Maximal Expiratory Pressure (MEP) | Week 12 | MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device. |
| Heart Rate Variability (HRV) Frequency | Week 12 | 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. |
| Diastolic Blood Pressure (DBP) | Week 12 | Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor. |
| Inspiratory Duration (ID) | Week 12 | ID measured in seconds will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop. |
Countries
United States
Outcome results
None listed