Back to resultsOrthostatic, Respiratory, Balance-Intervention (ORB-I)
Primary Purpose
Spinal Cord Injuries
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Inspiratory Muscle Training (IMT)
Sponsored by
About this trial
This is an interventional treatment trial for Spinal Cord Injuries focused on measuring Breathing, Diaphragm, Balance, Blood Pressure
Eligibility Criteria
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.
Sites / Locations
- The Miami Project to Cure Paralysis
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IMT Intervention
Arm Description
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.
Outcomes
Primary Outcome Measures
Percent Compliance of Training Sessions
Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Percent Compliance of Training Minutes
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).
Maximal Inspiratory Pressure (MIP)
MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Sustained Maximal Inspiratory Pressure (SMIP)
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.
Standard deviation of normal R-R intervals (SDNN)
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.
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
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.
Systolic Blood Pressure (SBP)
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Functional Seated Balance
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.
Quality of Life (QoL)
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.
Independence
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 Outcome Measures
Inspiratory Duration (ID)
ID measured in seconds will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Forced Vital Capacity
FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Forced Expiratory Volume in one Second (FEV1)
FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Peak Expiratory Flow (PEF)
PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Maximal Expiratory Pressure (MEP)
MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Heart Rate Variability (HRV) Frequency
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.
Diastolic Blood Pressure (DBP)
Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Full Information
NCT ID
NCT04210063
First Posted
December 18, 2019
Last Updated
August 7, 2020
Sponsor
University of Miami
Collaborators
Foundation for Physical Therapy, Inc., Craig H. Nielsen Foundation
1. Study Identification
Unique Protocol Identification Number
NCT04210063
Brief Title
Orthostatic, Respiratory, Balance-Intervention
Acronym
ORB-I
Official Title
Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
December 13, 2019 (Actual)
Primary Completion Date
July 29, 2020 (Actual)
Study Completion Date
July 29, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
Collaborators
Foundation for Physical Therapy, Inc., Craig H. Nielsen Foundation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries
Keywords
Breathing, Diaphragm, Balance, Blood Pressure
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
IMT Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Inspiratory Muscle Training (IMT)
Intervention Description
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 Outcome Measure Information:
Title
Percent Compliance of Training Sessions
Description
Feasibility of the IMT protocol will be reported as the percentage of completed daily sessions out of the 28 total session days.
Time Frame
4 weeks
Title
Percent Compliance of Training Minutes
Description
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).
Time Frame
4 weeks
Title
Maximal Inspiratory Pressure (MIP)
Description
MIP measured in cm H2O will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop
Time Frame
Week 12
Title
Sustained Maximal Inspiratory Pressure (SMIP)
Description
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.
Time Frame
Week 12
Title
Standard deviation of normal R-R intervals (SDNN)
Description
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.
Time Frame
Week 12
Title
Root Mean Squared of Successive Differences between Normal Heartbeats (rMSSD)
Description
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.
Time Frame
Week 12
Title
Systolic Blood Pressure (SBP)
Description
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Time Frame
Week 12
Title
Functional Seated Balance
Description
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.
Time Frame
Week 12
Title
Quality of Life (QoL)
Description
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.
Time Frame
Week 12
Title
Independence
Description
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.
Time Frame
Week 12
Secondary Outcome Measure Information:
Title
Inspiratory Duration (ID)
Description
ID measured in seconds will be assessed using the Pro2 handheld inspiratory measurement and training device connected to a tablet, phone or desktop.
Time Frame
Week 12
Title
Forced Vital Capacity
Description
FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Time Frame
Week 12
Title
Forced Expiratory Volume in one Second (FEV1)
Description
FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Time Frame
Week 12
Title
Peak Expiratory Flow (PEF)
Description
PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Time Frame
Week 12
Title
Maximal Expiratory Pressure (MEP)
Description
MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Time Frame
Week 12
Title
Heart Rate Variability (HRV) Frequency
Description
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.
Time Frame
Week 12
Title
Diastolic Blood Pressure (DBP)
Description
Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Time Frame
Week 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lawrence Cahalin, PhD
Organizational Affiliation
University of Maimi
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Miami Project to Cure Paralysis
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29400990
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.
Results Reference
background
PubMed Identifier
18367735
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.
Results Reference
background
PubMed Identifier
26718236
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.
Results Reference
background
PubMed Identifier
22785143
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.
Results Reference
background
PubMed Identifier
21445081
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.
Results Reference
background
PubMed Identifier
24870567
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.
Results Reference
background
PubMed Identifier
12080462
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.
Results Reference
background
PubMed Identifier
36309488
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.
Results Reference
derived
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Orthostatic, Respiratory, Balance-Intervention
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