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| Name | Class |
|---|---|
| Foundation for Physical Therapy, Inc. | INDUSTRY |
| The Craig H. Neilsen Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMT Intervention | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Training (IMT) | Other | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Cahalin, PhD | University of Maimi | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Miami Project to Cure Paralysis | Miami | Florida | 33136 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29400990 | Background | McDonald T, Stiller K. Inspiratory muscle training is feasible and safe for patients with acute spinal cord injury. J Spinal Cord Med. 2019 Mar;42(2):220-227. doi: 10.1080/10790268.2018.1432307. Epub 2018 Feb 5. | |
| 18367735 | Background | Levine S, Nguyen T, Taylor N, Friscia ME, Budak MT, Rothenberg P, Zhu J, Sachdeva R, Sonnad S, Kaiser LR, Rubinstein NA, Powers SK, Shrager JB. Rapid disuse atrophy of diaphragm fibers in mechanically ventilated humans. N Engl J Med. 2008 Mar 27;358(13):1327-35. doi: 10.1056/NEJMoa070447. |
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| ID | Term |
|---|---|
| D013119 | Spinal Cord Injuries |
| D053120 | Respiratory Aspiration |
| ID | Term |
|---|---|
| D013118 | Spinal Cord Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D020196 | Trauma, Nervous System |
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| 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 |
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 |
| 26718236 | Background | Aslan SC, Randall DC, Krassioukov AV, Phillips A, Ovechkin AV. Respiratory Training Improves Blood Pressure Regulation in Individuals With Chronic Spinal Cord Injury. Arch Phys Med Rehabil. 2016 Jun;97(6):964-73. doi: 10.1016/j.apmr.2015.11.018. Epub 2015 Dec 21. |
| 22785143 | Background | Mello PR, Guerra GM, Borile S, Rondon MU, Alves MJ, Negrao CE, Dal Lago P, Mostarda C, Irigoyen MC, Consolim-Colombo FM. Inspiratory muscle training reduces sympathetic nervous activity and improves inspiratory muscle weakness and quality of life in patients with chronic heart failure: a clinical trial. J Cardiopulm Rehabil Prev. 2012 Sep-Oct;32(5):255-61. doi: 10.1097/HCR.0b013e31825828da. |
| 21445081 | Background | Anderson KD, Acuff ME, Arp BG, Backus D, Chun S, Fisher K, Fjerstad JE, Graves DE, Greenwald K, Groah SL, Harkema SJ, Horton JA 3rd, Huang MN, Jennings M, Kelley KS, Kessler SM, Kirshblum S, Koltenuk S, Linke M, Ljungberg I, Nagy J, Nicolini L, Roach MJ, Salles S, Scelza WM, Read MS, Reeves RK, Scott MD, Tansey KE, Theis JL, Tolfo CZ, Whitney M, Williams CD, Winter CM, Zanca JM. United States (US) multi-center study to assess the validity and reliability of the Spinal Cord Independence Measure (SCIM III). Spinal Cord. 2011 Aug;49(8):880-5. doi: 10.1038/sc.2011.20. Epub 2011 Mar 29. |
| 24870567 | Background | Janssens L, McConnell AK, Pijnenburg M, Claeys K, Goossens N, Lysens R, Troosters T, Brumagne S. Inspiratory muscle training affects proprioceptive use and low back pain. Med Sci Sports Exerc. 2015 Jan;47(1):12-9. doi: 10.1249/MSS.0000000000000385. |
| 12080462 | Background | May LA, Warren S. Measuring quality of life of persons with spinal cord injury: external and structural validity. Spinal Cord. 2002 Jul;40(7):341-50. doi: 10.1038/sj.sc.3101311. |
| 36309488 | Derived | Palermo AE, Nash MS, Kirk-Sanchez NJ, Cahalin LP. Adherence to and impact of home-based high-intensity IMT in people with spinal cord injury: a pilot study. Spinal Cord Ser Cases. 2022 Oct 30;8(1):85. doi: 10.1038/s41394-022-00551-5. |
| D014947 | Wounds and Injuries |
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |