Orthostatic, Respiratory, Balance-Intervention

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)

Conditions
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Spinal Cord Injuries

Intervention / Treatment
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* Other: Inspiratory Muscle Training (IMT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. ≥1 year post-injury Willingness to participate in the study and provide consent. Exclusion Criteria: Inability to understand the consent form or consent process Reliance on a mechanical ventilator. Use of Betablockers Inability to travel to The Miami Project for weekly sessions during intervention month 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. Individuals who are able to stand independently or with a walker Unresolved deep vein thrombosis (DVT). Hospitalization due to autonomic dysreflexia in the last 3 months. Pregnancy determined by urine testing in sexually active females.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT Intervention<br>During the first month, participants will be in a month-long control wash in period where no intervention will be provided. During the second month, participants will be in a 4-week daily IMT intervention period. During the third month, participants will be in a month-long efficacy period with no intervention provided. | Other: Inspiratory Muscle Training (IMT)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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). | 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 | 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. | 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. | 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. | Week 12 | 
| Systolic Blood Pressure (SBP) | Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor. | 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. | 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. | 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. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | Week 12 | 
| Forced Vital Capacity | FVC, evaluated in liters, will be measured using a handheld digital spirometer device. | Week 12 | 
| Forced Expiratory Volume in one Second (FEV1) | FEV1, evaluated in liters, will be measured using a handheld digital spirometer device. | Week 12 | 
| Peak Expiratory Flow (PEF) | PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device. | Week 12 | 
| Maximal Expiratory Pressure (MEP) | MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device. | 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. | Week 12 | 
| Diastolic Blood Pressure (DBP) | Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breathing, Diaphragm, Balance, Blood Pressure