Orthostatic, Respiratory, Balance-Intervention

Spinal Cord Injuries Clinical Trial

— ORB-I  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04210063
• Other study ID #: 20190838
• Status: Completed
• Phase: N/A
• Start date: December 13, 2019
• Est. completion date: July 29, 2020

Study information

• Verified date: August 2020
• Source: University of Miami
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: July 29, 2020
• Est. primary completion date: July 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Spinal Cord Injuries

Intervention

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.

Locations

Country	Name	City	State
United States	The Miami Project to Cure Paralysis	Miami	Florida

Sponsors (3)

Lead Sponsor	Collaborator
University of Miami	Craig H. Nielsen Foundation, Foundation for Physical Therapy, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (7)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

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