Orthostatic, Respiratory, Balance-Intervention

NCT04210063 | Completed

• 1 other identifier: 20190838
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Spinal Cord Injuries

Keywords

Breathing; Diaphragm; Balance; Blood Pressure

Outcome Measures

Primary Outcomes (10)

• 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.

  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).

  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

  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.

  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.

  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.

  Week 12

• Systolic Blood Pressure (SBP)

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

  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.

  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.

  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.

  Week 12

Secondary Outcomes (7)

• Inspiratory Duration (ID)

  Week 12

• Forced Vital Capacity

  Week 12

• Forced Expiratory Volume in one Second (FEV1)

  Week 12

• Peak Expiratory Flow (PEF)

  Week 12

• Maximal Expiratory Pressure (MEP)

  Week 12

Study Arms (1)

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.

Other: Inspiratory Muscle Training (IMT)

Interventions

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.

IMT Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Miami: lead
• Foundation for Physical Therapy, Inc.: collaborator
• The Craig H. Neilsen Foundation: collaborator

Study Sites (1)

The Miami Project to Cure Paralysis

Miami, Florida, 33136, United States

Location

Related Publications (8)

• 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.

  PMID: 29400990 BACKGROUND

• 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.

  PMID: 18367735 BACKGROUND

• 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.

  PMID: 26718236 BACKGROUND

• 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.

  PMID: 22785143 BACKGROUND

• 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.

  PMID: 21445081 BACKGROUND

• 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.

  PMID: 24870567 BACKGROUND

• 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.

  PMID: 12080462 BACKGROUND

• 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.

  PMID: 36309488 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Respiratory Aspiration

Condition Hierarchy (Ancestors)

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

Study Officials

• Lawrence Cahalin, PhD

  University of Maimi

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: December 18, 2019
• First Posted: December 24, 2019
• Study Start: December 13, 2019
• Primary Completion: July 29, 2020
• Study Completion: July 29, 2020
• Last Updated: August 11, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)