ORB-I: Orthostatic, Respiratory, Balance-Intervention

• Sponsor: University of Miami (Other)
• Overall Status: Completed
• CT.gov ID: NCT04210063
• Collaborator: Foundation for Physical Therapy, Inc. (Industry), Craig H. Nielsen Foundation (Other)
• Enrollment: 18
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.5
• Patients Per Site Per Month: 2.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Spinal Cord Injuries	Other: Inspiratory Muscle Training (IMT)	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
• Actual Study Start Date: Dec 13, 2019
• Actual Primary Completion Date: Jul 29, 2020
• Actual Study Completion Date: Jul 29, 2020

Arms and Interventions

Arm

Intervention/Treatment

Experimental: IMT Intervention 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); 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.

Outcome Measures

Primary Outcome Measures

1. 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.

2. 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).

3. 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

4. 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.

5. 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.

6. 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.

7. Systolic Blood Pressure (SBP) [Week 12]

   Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.

8. 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.

9. 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.

10. 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.

Secondary Outcome Measures

1. 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.

2. Forced Vital Capacity [Week 12]

   FVC, evaluated in liters, will be measured using a handheld digital spirometer device.

3. Forced Expiratory Volume in one Second (FEV1) [Week 12]

   FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.

4. Peak Expiratory Flow (PEF) [Week 12]

   PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.

5. Maximal Expiratory Pressure (MEP) [Week 12]

   MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.

6. 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.

7. Diastolic Blood Pressure (DBP) [Week 12]

   Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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.

1. Individuals who are able to stand independently or with a walker

2. Unresolved deep vein thrombosis (DVT).

3. Hospitalization due to autonomic dysreflexia in the last 3 months.

4. Pregnancy determined by urine testing in sexually active females.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The Miami Project to Cure Paralysis	Miami	Florida	United States	33136

Sponsors and Collaborators

• University of Miami
• Foundation for Physical Therapy, Inc.
• Craig H. Nielsen Foundation

Investigators

• Principal Investigator: Lawrence Cahalin, PhD, University of Maimi

Study Documents (Full-Text)

None provided.

More Information

Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• Mello PR, Guerra GM, Borile S, Rondon MU, Alves MJ, Negrão 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.

• Responsible Party: Lawrence Cahalin, Clinical Professor, University of Miami
• ClinicalTrials.gov Identifier: NCT04210063
• Other Study ID Numbers: 20190838
• First Posted: Dec 24, 2019
• Last Update Posted: Aug 11, 2020
• Last Verified: Aug 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Lawrence Cahalin, Clinical Professor, University of Miami: Breathing; Diaphragm; Balance; Blood Pressure
• Additional relevant MeSH terms: Spinal Cord Injuries

Study Results

No Results Posted as of Aug 11, 2020