Clinical trial NCT04210063: Orthostatic, Respiratory, Balance-Intervention
Official title: Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: Breathing
Diaphragm
Balance
Blood Pressure
Lead sponsor: University of Miami
Sponsor class: OTHER
Collaborators: name: Foundation for Physical Therapy, Inc.
name: The Craig H. Neilsen Foundation
First posted: 2019-12-24
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Percent Compliance of Training Sessions
timeFrame: 4 weeks
measure: Percent Compliance of Training Minutes
timeFrame: 4 weeks
measure: Maximal Inspiratory Pressure (MIP)
timeFrame: Week 12
measure: Sustained Maximal Inspiratory Pressure (SMIP)
timeFrame: Week 12
measure: Standard deviation of normal R-R intervals (SDNN)
timeFrame: Week 12
measure: Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
timeFrame: Week 12
measure: Systolic Blood Pressure (SBP)
timeFrame: Week 12
measure: Functional Seated Balance
timeFrame: Week 12
measure: Quality of Life (QoL)
timeFrame: Week 12
measure: Independence
timeFrame: Week 12
Secondary outcomes:
measure: Inspiratory Duration (ID)
timeFrame: Week 12
measure: Forced Vital Capacity
timeFrame: Week 12
measure: Forced Expiratory Volume in one Second (FEV1)
timeFrame: Week 12
measure: Peak Expiratory Flow (PEF)
timeFrame: Week 12
measure: Maximal Expiratory Pressure (MEP)
timeFrame: Week 12
measure: Heart Rate Variability (HRV) Frequency
timeFrame: Week 12
measure: Diastolic Blood Pressure (DBP)
timeFrame: Week 12
Other outcomes:
Locations:
city: Miami
country: United States
facility: The Miami Project to Cure Paralysis
state: Florida
Study officials:
affiliation: University of Maimi
name: Lawrence Cahalin, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
citation: 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.
citation: 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.
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.
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. doi: 10.1038/sj.sc.3101311.
citation: 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.