Orthostatic, Respiratory, Balance-Intervention (ORB-I)

August 7, 2020 updated by: Lawrence Cahalin, University of Miami

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Miami, Florida, United States, 33136
        • The Miami Project to Cure Paralysis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: IMT Intervention
During the first month, participants will be in a month-long control wash in period where no intervention will be provided. During the second month, participants will be in a 4-week daily IMT intervention period. During the third month, participants will be in a month-long efficacy period with no intervention provided.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
4 weeks
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).
4 weeks
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
Week 12
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.
Week 12
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.
Week 12
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.
Week 12
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.
Week 12
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.
Week 12
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.
Week 12
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.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Week 12
Forced Vital Capacity
Time Frame: Week 12
FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Week 12
Forced Expiratory Volume in one Second (FEV1)
Time Frame: Week 12
FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Week 12
Peak Expiratory Flow (PEF)
Time Frame: Week 12
PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Week 12
Maximal Expiratory Pressure (MEP)
Time Frame: Week 12
MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Week 12
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.
Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Miami

Collaborators

Foundation for Physical Therapy, Inc.
Craig H. Nielsen Foundation

Investigators

  • Principal Investigator: Lawrence Cahalin, PhD, University of Maimi

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2019

Primary Completion (Actual)

July 29, 2020

Study Completion (Actual)

July 29, 2020

Study Registration Dates

First Submitted

December 18, 2019

First Submitted That Met QC Criteria

December 20, 2019

First Posted (Actual)

December 24, 2019

Study Record Updates

Last Update Posted (Actual)

August 11, 2020

Last Update Submitted That Met QC Criteria

August 7, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20190838

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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