Mechanisms of Arterial Hypotension in Chronic Spinal Cord Injury

NCT02154412 | Completed

• 1 other identifier: 11.0286 Ovechkin
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical study is designed to investigate the mechanisms of blood pressure regulation and respiratory motor function affected by spinal cord injury (SCI). We hypothesize that impaired blood pressure regulation in individuals with chronic SCI can be improved by restoring respiratory motor function by using Respiratory Motor Training (RMT).

Conditions

Spinal Cord Injury

Keywords

Respiration; Motor control; Blood Pressure; Orthostatic Hypotension

Outcome Measures

Primary Outcomes (1)

• Pulmonary function test

  Standard spirometry measures in percent predicted values

  Before and after 20 sessions of RMT

Secondary Outcomes (2)

• Blood pressure change measurement

  Before and after 20 sessions of RMT

• Maximum airway pressure

  Before and after 20 sessions of RMT

Other Outcomes (1)

• Cardiac ultrasound

  Before and After 20 RMT sessions

Study Arms (2)

Respiratory training

EXPERIMENTAL

Subjects will be seated in own wheelchair with head-up tilt. Assembled together, a threshold Positive Expiratory Pressure Device (Respironics, Inc.) \& an Inspiratory Muscle Trainer (IMT, Respironics Inc.) with mouthpiece will be used. Subjects will perform maximal inspiratory and expiratory efforts against a pressure load. Participants will be asked to train 45 minutes per day, 5 days per week, for 4 weeks. The training will be initiated with a load equal to 20% of their individual PImax and PEmax with progressive increases as tolerated up to 40% of their baseline PImax or PEmax.

Other: Respiratory Training

No respiratory training

NO INTERVENTION

Participants will not participate in the respiratory muscle training.

Interventions

Respiratory Training OTHER

Assembled together using a T-shaped connector, a threshold Positive Expiratory Pressure Device (Respironics, Inc.) \& an Inspiratory Muscle Trainer (IMT, Respironics Inc.) with mouthpiece will be used. During inhalation, the subjects will initiate each breath from residual volume (RV) and to sustain the effort until their lungs feel full. During exhalation, the subjects will breathe from total lung capacity and sustain their effort until their lungs feel empty. Participants will be asked to train 45 minutes per day, 5 days per week, for 4 weeks. The training will be initiated with a load equal to 20% of their individual PImax and PEmax with progressive increases as tolerated up to 40% of their baseline PImax or PEmax.

Respiratory training

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Non-progressive chronic Spinal Cord Injury (SCI)
• At least 18 years old
• Stable medical condition
• No diseases or conditions that would contraindicate the respiratory muscle training (RMT)
• Not ventilator-dependent for respiration
• At least 15%-deficit in pulmonary function outcome measures
• Orthostatic hypotension

You may not qualify if:

• Major cardiovascular or pulmonary disease
• Endocrine disorders
• Malignancy
• Pregnancy (no pregnancy test or birth control regimen will be required)

Sponsors & Collaborators

• University of Louisville: lead
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, 40202, United States

Location

Related Publications (12)

• DeVivo MJ, Krause JS, Lammertse DP. Recent trends in mortality and causes of death among persons with spinal cord injury. Arch Phys Med Rehabil. 1999 Nov;80(11):1411-9. doi: 10.1016/s0003-9993(99)90252-6.

  PMID: 10569435 BACKGROUND

• Krassioukov A. Autonomic function following cervical spinal cord injury. Respir Physiol Neurobiol. 2009 Nov 30;169(2):157-64. doi: 10.1016/j.resp.2009.08.003. Epub 2009 Aug 12.

  PMID: 19682607 BACKGROUND

• Teasell RW, Arnold JM, Krassioukov A, Delaney GA. Cardiovascular consequences of loss of supraspinal control of the sympathetic nervous system after spinal cord injury. Arch Phys Med Rehabil. 2000 Apr;81(4):506-16. doi: 10.1053/mr.2000.3848.

  PMID: 10768544 BACKGROUND

• Claydon VE, Krassioukov AV. Orthostatic hypotension and autonomic pathways after spinal cord injury. J Neurotrauma. 2006 Dec;23(12):1713-25. doi: 10.1089/neu.2006.23.1713.

  PMID: 17184183 BACKGROUND

• Bernard PL, Mercier J, Varray A, Prefaut C. Influence of lesion level on the cardioventilatory adaptations in paraplegic wheelchair athletes during muscular exercise. Spinal Cord. 2000 Jan;38(1):16-25. doi: 10.1038/sj.sc.3100956.

  PMID: 10762193 BACKGROUND

• Frankel HL, Coll JR, Charlifue SW, Whiteneck GG, Gardner BP, Jamous MA, Krishnan KR, Nuseibeh I, Savic G, Sett P. Long-term survival in spinal cord injury: a fifty year investigation. Spinal Cord. 1998 Apr;36(4):266-74. doi: 10.1038/sj.sc.3100638.

  PMID: 9589527 BACKGROUND

• Garshick E, Kelley A, Cohen SA, Garrison A, Tun CG, Gagnon D, Brown R. A prospective assessment of mortality in chronic spinal cord injury. Spinal Cord. 2005 Jul;43(7):408-16. doi: 10.1038/sj.sc.3101729.

  PMID: 15711609 BACKGROUND

• De Troyer A, Estenne M, Heilporn A. Mechanism of active expiration in tetraplegic subjects. N Engl J Med. 1986 Mar 20;314(12):740-4. doi: 10.1056/NEJM198603203141203.

  PMID: 3951503 BACKGROUND

• Winslow C, Rozovsky J. Effect of spinal cord injury on the respiratory system. Am J Phys Med Rehabil. 2003 Oct;82(10):803-14. doi: 10.1097/01.PHM.0000078184.08835.01.

  PMID: 14508412 BACKGROUND

• Laffont I, Durand MC, Rech C, De La Sotta AP, Hart N, Dizien O, Lofaso F. Breathlessness associated with abdominal spastic contraction in a patient with C4 tetraplegia: a case report. Arch Phys Med Rehabil. 2003 Jun;84(6):906-8. doi: 10.1016/s0003-9993(02)04898-0.

  PMID: 12808547 BACKGROUND

• Walter JS, Sacks J, Othman R, Rankin AZ, Nemchausky B, Chintam R, Wheeler JS. A database of self-reported secondary medical problems among VA spinal cord injury patients: its role in clinical care and management. J Rehabil Res Dev. 2002 Jan-Feb;39(1):53-61.

  PMID: 11926327 BACKGROUND

• Claydon VE, Steeves JD, Krassioukov A. Orthostatic hypotension following spinal cord injury: understanding clinical pathophysiology. Spinal Cord. 2006 Jun;44(6):341-51. doi: 10.1038/sj.sc.3101855. Epub 2005 Nov 22.

  PMID: 16304564 BACKGROUND

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Aspiration; Hypotension, Orthostatic

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Orthostatic Intolerance; Primary Dysautonomias; Autonomic Nervous System Diseases; Hypotension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Exercise Movement Techniques; Physical Therapy Modalities

Study Officials

• Alexander Ovechkin, PhD

  University of Louisville

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: May 30, 2014
• First Posted: June 3, 2014
• Study Start: June 1, 2011
• Primary Completion: April 30, 2019
• Study Completion: April 30, 2019
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)