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Completed

NCT Number: NCT04210063

Orthostatic, Respiratory, Balance-Intervention

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.

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Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Nervous System Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • ≥1 year post-injury
  • Willingness to participate in the study and provide consent.

Exclusion criteria

  • Inability to understand the consent form or consent process
  • Reliance on a mechanical ventilator.
  • Use of Betablockers
  • Inability to travel to The Miami Project for weekly sessions during intervention month
  • 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.
  • Individuals who are able to stand independently or with a walker
  • Unresolved deep vein thrombosis (DVT).
  • Hospitalization due to autonomic dysreflexia in the last 3 months.
  • Pregnancy determined by urine testing in sexually active females.

Treatment and study plan

Inspiratory muscle training (IMT)

Other

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.

Primary outcomes

  1. Percent Compliance of Training Sessions

    Time frame: 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

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: 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)

    Time frame: Week 12

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

  8. Functional Seated Balance

    Time frame: 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)

    Time frame: 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

    Time frame: 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 outcomes

  1. Inspiratory Duration (ID)

    Time frame: 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

    Time frame: Week 12

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

  3. Forced Expiratory Volume in one Second (FEV1)

    Time frame: Week 12

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

  4. Peak Expiratory Flow (PEF)

    Time frame: Week 12

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

  5. Maximal Expiratory Pressure (MEP)

    Time frame: Week 12

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

  6. Heart Rate Variability (HRV) Frequency

    Time frame: 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)

    Time frame: Week 12

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

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Foundation for Physical Therapy, Inc.
  • The Craig H. Neilsen Foundation

Registry information

Official study title

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

Acronym: ORB-I

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2019
Registry last updated
Aug 11, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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