Respiratory Motor Control and Blood Pressure Regulation After Spinal Cord Injury

NCT02396823 | Completed

• 2 other identifiers: OICB101489R01HL103750-01A1
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

The proposed study is designed to answer a novel research question: Can resistive respiratory muscle training designed to improve respiratory motor control also improve blood pressure regulation impaired by spinal cord injury? Resistive breathing exercise, or respiratory muscle training, has been applied to rehabilitate breathing after spinal cord injury, but has not been evaluated as a method for increasing resting blood pressure and / or improving its regulation under stress as is planned in the proposed project. For the first time, respiratory muscle training intervention will be used as a tool to investigate the physiological relationships between pulmonary and cardiovascular function in individuals with Spinal Cord Injury (SCI). Thus, it will foster a new direction from which to address neglected issues surrounding the cardiovascular complications of spinal cord injury.

Conditions

Spinal Cord Injury

Keywords

Blood pressure regulation; Respiratory Muscle Training

Outcome Measures

Primary Outcomes (1)

• Changes in Pulmonary Function Test outcomes

  Lung volumes, capacities, air flow, and airway pressure assessed using standard spirometry and maximum airway pressure recordings.

  At baseline, after 1-month long respiratory training, and during 6 months of follow-up period

Secondary Outcomes (3)

• Changes in Respiratory Motor Control Assessment outcomes

  At baseline, after 1-month long respiratory training, and during 6 months of follow-up period

• Changes in Orthostatic Stress Test outcomes

  At baseline, after 1-month long respiratory training, and during 6 months of follow-up period

• Changes in cardiac output

  At baseline, after 1-month long respiratory training, and during 6 months of follow-up period

Study Arms (2)

Respiratory Muscle Training

EXPERIMENTAL

Each training session will last about 45-60 min and will occur five times weekly during one month. During the RMT sessions, the patient will remain in their personal wheelchair. They will be asked to breath through a special device with regulated resistance to breathing air. In the 20 sessions starting from the lowest resistance, the goal will be to train the muscles they use to breathe by slowly increasing this resistance. They will perform six work sets, 5 minutes in duration, separated by rest intervals lasting 1-3 minutes.

Behavioral: Respiratory Muscle Training

Control

NO INTERVENTION

Following screening process and recruiting, subjects from both Healthy Control and SCI Control groups will undergo the same procedures as subjects from SCI group excluding the training intervention.

Interventions

Respiratory Muscle Training BEHAVIORAL

Standard threshold Positive Expiratory Pressure Device and threshold Inspiratory Muscle Trainer assembled together using a T-shaped connector with flanged mouthpiece will be used. The participants will be instructed to perform inspiratory and expiratory efforts against a resistive load. Training session lasts 45 minutes per day, 5 days per week, for 4 weeks.

Respiratory Muscle Training

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• At least 18 years old;
• stable medical condition without diseases or autonomic dysreflexia that would contraindicate RMT;
• no painful musculoskeletal dysfunction, unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with RMT;
• no clinically significant depression, psychiatric disorders or ongoing drug abuse;
• clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms;
• no current anti-spasticity medication regimen;
• non-progressive C3-T5 American Spinal Cord Injury Association Designation of A-D SCI;
• not ventilator dependent for respiration;
• sustained SCI at least 6 months prior to entering the study;
• at least 15%-deficit in pulmonary function outcomes (FVC and FEV1) detected by screening spirometry; and
• orthostatic hypotension (the decrease 20mm Hg or more in systolic or a reduction 10mm Hg or more in diastolic blood pressure on changing body position from a supine to an upright) detected by screening orthostatic stress test

You may not qualify if:

• a presence of major cardiovascular or pulmonary disease, endocrine disorders, malignancy, marked obesity, deep vein thrombosis, and major gastrointestinal problem such as swallowing or other major medical illness contraindicated for respiratory muscle training or testing.
• Pregnant women are excluded from this study, as the risk to the fetus is unknown. No pregnancy test or birth control regimen will be required.

Sponsors & Collaborators

• University of Louisville: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (1)

Frazier Rehabilitation and Neuroscience Institute

Louisville, Kentucky, 40202, United States

Location

Related Publications (1)

• Legg Ditterline BE, Aslan SC, Randall DC, Harkema SJ, Castillo C, Ovechkin AV. Effects of Respiratory Training on Heart Rate Variability and Baroreflex Sensitivity in Individuals With Chronic Spinal Cord Injury. Arch Phys Med Rehabil. 2018 Mar;99(3):423-432. doi: 10.1016/j.apmr.2017.06.033. Epub 2017 Aug 9.

  PMID: 28802811 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Breathing Exercises

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alexander Ovechkin, MD, PhD

  avovec02@louisville.edu

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 24, 2015
• First Posted: March 24, 2015
• Study Start: June 1, 2011
• Primary Completion: October 1, 2016
• Study Completion: February 1, 2019
• Last Updated: March 7, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Pre-processed data will be available from November 2016 to December 2027.
• Access Criteria: Deidentified data sets

Locations

US (1)