Spinal Cord InjuriesORB-INCT04210063
Orthostatic, Respiratory, Balance-Intervention
A study testing Inspiratory Muscle Training (IMT) in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- Inspiratory Muscle Training (IMT)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Dec 2019to 29 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miami Project to Cure Paralysis
Miami, Florida, 33136
About this study
Official title: 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.
- Conditions
- Spinal Cord Injuries
- Being tested
- Inspiratory Muscle Training (IMT)
- Keywords
- Breathing, Diaphragm, Balance, Blood Pressure
- Medical subject headings
- Spinal Cord Injuries, Respiratory Aspiration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| IMT Intervention | Experimental | 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. Receives: Other: Inspiratory Muscle Training (IMT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 weeks
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).
Measured: 4 weeks
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
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
Systolic Blood Pressure (SBP)
Brachial systolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
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.
Measured: Week 12
Secondary outcomes (7)
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.
Measured: Week 12
Forced Vital Capacity
FVC, evaluated in liters, will be measured using a handheld digital spirometer device.
Measured: Week 12
Forced Expiratory Volume in one Second (FEV1)
FEV1, evaluated in liters, will be measured using a handheld digital spirometer device.
Measured: Week 12
Peak Expiratory Flow (PEF)
PEF, evaluated in liters/minute, will be measured using a handheld digital spirometer device.
Measured: Week 12
Maximal Expiratory Pressure (MEP)
MEP, evaluated in cm H2O, will be measured using a handheld digital spirometer device.
Measured: Week 12
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.
Measured: Week 12
Diastolic Blood Pressure (DBP)
Brachial diastolic BP, evaluated in mmHg, will be evaluated using the contralateral arm with a Spot Vitals Monitor.
Measured: Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2019
- Study start13 Dec 2019
- Primary completion29 Jul 2020
- Study completion29 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., The Craig H. Neilsen Foundation
- Responsible party
- Principal investigator, Lawrence Cahalin, University of Miami
- Investigators
- Lawrence Cahalin, PhD, Principal investigator, University of Maimi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04210063
- Sponsor's protocol ID
- 20190838
- Acronym
- ORB-I
- Status last verified
- Aug 2020
- First submitted
- 18 Dec 2019
- Last updated
- 11 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 29400990Levine 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.
PubMed 18367735Aslan 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.
PubMed 26718236Mello 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.
PubMed 22785143Anderson 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.
PubMed 21445081Janssens 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.
PubMed 24870567May 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.
PubMed 12080462Palermo 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.
PubMed 36309488
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Inspiratory Muscle Training (IMT) on Breathing, Balance, and Blood Pressure Maintenance in Spinal Cord Injury (SCI)
- ClinicalTrials.gov ID
- NCT04210063
- Acronym / sponsor ID
- ORB-I / 20190838
- Conditions
- Spinal Cord Injuries
- Keywords
- Breathing, Diaphragm, Balance, Blood Pressure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Collaborators
- Foundation for Physical Therapy, Inc., The Craig H. Neilsen Foundation
- Study start
- 13 Dec 2019 (actual)
- Primary completion
- 29 Jul 2020 (actual)
- Study completion
- 29 Jul 2020 (actual)
- First posted
- 24 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| IMT Intervention | Experimental | Other: Inspiratory Muscle Training (IMT)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (12 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | IMT Intervention |
Primary outcome
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.
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).
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
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.
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.
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.
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.
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.
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.
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.
7 secondary outcomes
Inspiratory Duration (ID)
Time frame: Week 12
Forced Vital Capacity
Time frame: Week 12
Forced Expiratory Volume in one Second (FEV1)
Time frame: Week 12
Peak Expiratory Flow (PEF)
Time frame: Week 12
Maximal Expiratory Pressure (MEP)
Time frame: Week 12
Heart Rate Variability (HRV) Frequency
Time frame: Week 12
Diastolic Blood Pressure (DBP)
Time frame: Week 12
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2020.
- Background: PubMed 29400990McDonald 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.
- Background: PubMed 18367735Levine 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.
- Background: PubMed 26718236Aslan 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.
- Background: PubMed 22785143Mello 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.
- Background: PubMed 21445081Anderson 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.
- Background: PubMed 24870567Janssens 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.
- Background: PubMed 12080462May 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.
- Derived from this study: PubMed 36309488Palermo 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Cahalin, PhD principal investigator
University of Maimi
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory Muscle Training (IMT) in people with Spinal Cord Injuries, run by University of Miami at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent Compliance of Training Sessions (time frame: 4 weeks). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04210063, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2020; AzTrials last refreshed its copy on 30 Oct 2026.