Exercise Training and Manual Wheelchair Users With SCI

NCT03727893 | Completed

• 1 other identifier: 201804087
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

The overall purpose of this pilot randomized control trial (RCT) is to determine the efficacy of the high-intensity interval training (HIIT) exercise protocols for the WheelMill System (WMS) to improve exercise intensity, cardiovascular fitness, metabolic health, and psychological well-being in manual wheelchair users (MWUs) with spinal cord injury (SCI).

Conditions

Spinal Cord Injuries

Keywords

manual wheelchairs; wheelchair propulsion; high intensity exercise training

Outcome Measures

Primary Outcomes (2)

• VO2peak Change

  VO2 peak will be measured using a standard computer-integrated, open-circuit, breath-by-breath metabolic measurement system (TrueOne 2400, Parvo Medics, Sandy, UT, US) while the participant performs a graded-exercise test on an ACE, SCIFIT PRO2 (Life Fitness, Tulsa, OK, US). In addition, an H7 Heart Rate Sensor (Polar Electro Inc., Lake Success, NY, US) will be placed on each participant to monitor heart rate during testing. Each participant will be fitted with a silicone mask to cover his or her mouth and nose while performing the exercise test, which is typically completed in 8-12 minutes depending on the participant's fitness level. The protocol involves a 3-minute warm-up at a workload of 8-10 watts (W) followed by a standard ACE ramp protocol. The ramp protocol requires participants to maintain 60 revolutions per minute (rpm) with incremental increases by 7 W every minute, until exhaustion.

  Baseline to Post Intervention at 4 months

• The 6-minute Push Test (6MPT) Change

  The 6MPT is a functional mobility and physical fitness test involving manual wheelchair users propelling a designated 30-meter loop. Participants are asked to propel as far as possible on the course within 6 minutes. Total distance propelled is determined by tallying the number of completed 30-meter loops and measuring the partially completed final lap using a tape measure.

  Baseline to Post Intervention at 4 months

Secondary Outcomes (10)

• Wong-Baker FACES pain scale (FACES)

  At baseline. During each intervention session. At follow up assessment.

• PROMIS-29 Profile (v2.0) Change

  Baseline and Post Intervention at 4 months

• Leisure Time Physical Activity for People with Spinal Cord Injury (LTPAQ-SCI) Change

  Baseline and Post Intervention at 4 months

• Wheelchair User's Shoulder Pain Index (WUSPI) Change

  Baseline and Post Intervention at 4 months

• Wheelchair Skills Test Questionnaire (WST-Q) Change

  Baseline and Post Intervention at 4 months

Study Arms (2)

Roller-based intervention Group (IG)

ACTIVE COMPARATOR

A group participating in a high-intensity exercise on a roller-based system.

Behavioral: Roller-based Intervention Group (IG)

Control Group (CG)

PLACEBO COMPARATOR

A group participating in an independent workout program at an accessible community-based fitness facility.

Behavioral: Control Group (CG)

Interventions

Roller-based Intervention Group (IG) BEHAVIORAL

A group of manual wheelchair users (MWUs) with spinal cord injury (SCI) that will complete an initial exercise education and a 12-week (3 sessions per week) evidence-based high-intensity interval training (HIIT) program using the roller-based WheelMill (WMS) system.

Roller-based intervention Group (IG)

Control Group (CG) BEHAVIORAL

A group of manual wheelchair users (MWUs) with spinal cord injury (SCI) that will complete an initial exercise education session and enroll in a 12-week (3 sessions per week) independent workout program at an accessible community-based fitness facility.

Control Group (CG)

Eligibility Criteria

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

You may qualify if:

• Participants will have a diagnosis of spinal cord injury (SCI)
• be18 years or older
• have the ability to self-propel a manual wheelchair (MWC) bilaterally with their upper extremities
• use a MWC for at least 75% of their daily activities
• participate in less than 60 minutes of moderate-intensity exercise per week in the last month
• have written physician approval to participate in the study
• understand English at a sixth-grade level or higher
• be able to follow multi-step instructions
• independently provide informed consent
• be willing to participate in two assessments and 36 intervention sessions at the Enabling Mobility in the Community Laboratory (EMC Lab).

You may not qualify if:

• maneuver MWC with their lower extremities or with only one upper extremity
• have bilateral incoordination due to strength inequality or neurological involvement that impairs propulsion in a steady, straight line
• have had surgeries compromising the integrity of the upper extremities or cardiovascular complications within the past year
• currently receive medical treatment for an acute upper extremity injury
• have a Stage IV pressure injury
• are currently hospitalized
• have a cognitive impairment that does not allow them to provide consent or follow multi-step directions.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• Spinal Cord Injury/Disease Research Program: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63108, United States

Location

Related Publications (33)

• National Spinal Cord Injury Statistical Center. (2016). 2016 Annual Statistical Report - Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.

  BACKGROUND

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• American College of Sports Medicine. (2014). ACSM's Guidelines for Exercise Testing and Prescription (9th ed.). Philadelphia: Lippincott Williams & Wilkins.

  BACKGROUND

• Evans N, Wingo B, Sasso E, Hicks A, Gorgey AS, Harness E. Exercise Recommendations and Considerations for Persons With Spinal Cord Injury. Arch Phys Med Rehabil. 2015 Sep;96(9):1749-50. doi: 10.1016/j.apmr.2015.02.005. Epub 2015 Jul 18. No abstract available.

  PMID: 26198424 BACKGROUND

• Totosy de Zepetnek JO, Pelletier CA, Hicks AL, MacDonald MJ. Following the Physical Activity Guidelines for Adults With Spinal Cord Injury for 16 Weeks Does Not Improve Vascular Health: A Randomized Controlled Trial. Arch Phys Med Rehabil. 2015 Sep;96(9):1566-75. doi: 10.1016/j.apmr.2015.05.019. Epub 2015 Jun 10.

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• Gebel K, Ding D, Chey T, Stamatakis E, Brown WJ, Bauman AE. Effect of Moderate to Vigorous Physical Activity on All-Cause Mortality in Middle-aged and Older Australians. JAMA Intern Med. 2015 Jun;175(6):970-7. doi: 10.1001/jamainternmed.2015.0541.

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• U.S. Department of Health and Human Services (2008). 2008 Physical Activity Guidelines for Americans. Washington, D. C.: U.S. Department of Health and Human Services.

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MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Officials

• Joseph W Klaesner, PhD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Program in Physical Therapy, Department of Radiology, Department of Biomedical Engineering

Study Record Dates

• First Submitted: September 26, 2018
• First Posted: November 1, 2018
• Study Start: October 22, 2018
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: February 23, 2022

Record last verified: 2022-02

Locations

US (1)