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Spinal Cord InjuriesNCT03727893

Exercise Training and Manual Wheelchair Users With SCI

A study testing Roller-based Intervention Group (IG) in people with Spinal Cord Injuries, run by Washington University School of Medicine at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… 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?
Roller-based Intervention Group (IG)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
14 participants
Where
1 siteUnited States
Study dates
22 Oct 2018to 31 Dec 2021
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

  • 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
Show all 10Show fewer
  • 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).

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Washington University School of Medicine

    St Louis, Missouri, 63108

Other trials in United States

About this study

Official title: Application of the WMS for Advanced Physical Training of Manual Wheelchair Users With Spinal Cord Injury

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).

Read the detailed description

People with spinal cord injuries (SCI) are at greater health risk for major health conditions and poorer health outcomes than the population without disabilities. For people with SCI, physical activity is critical for both physiological and psychosocial well-being, however 75% of persons with SCI are not active enough to achieve activity-related health benefits. While current exercise guidelines for persons with SCI are limited and vary, health authorities and literature have focused more on recommendations for moderate-intensity exercise, however recent studies have shown that, due to the reduced exercise capacity of the active muscles used in persons with SCI, moderate-intensity exercise alone is inadequate to stimulate meaningful improvements in cardiovascular disease risk. An alternative exercise approach that has demonstrated significant reductions in cardiovascular disease risk and morality is high-intensity interval training (HIIT). Participating in exercise protocols of higher intensity may offer a more effective and time-efficient method of increasing cardiovascular fitness and metabolic health in persons with SCI. However, few studies have evaluated the efficacy of HIIT protocols to increase exercise intensity and clinically improve cardio metabolic health and fitness in this population. The WheelMill System (WMS) is a wheelchair roller-based system that allows persons with SCI to use their personal manual wheelchair for wheelchair training or endurance exercise. With this study, we aim to assess the efficacy of a HIIT intervention conducted on a wheelchair roller-based system in improving cardiorespiratory and metabolic function, psychosocial well-being, and exercise intensity for manual wheelchair users (MWUs) with SCI. We also aim to determine if the roller-based system is a feasible platform for delivering HIIT for MWUs with SCI as well as identifying the perspectives of the participants on the recruitment and enrollment process, the assessment methods, and tolerance and acceptance of the intervention protocol. The long-term goal of this research is to increase cardiorespiratory fitness and reduce cardiovascular and metabolic disease risk in MWUs. This study will serve as the initial step toward that goal by pilot testing a HIIT intervention to increase exercise intensity of MWUs with SCI to promote physiological and psychosocial activity-related health benefits. We will recruit, enroll, and randomize MWUs with SCI into a roller-based Intervention Group (IG) or the Control Group (CG). Participants in the IG will complete an initial exercise education session and a 12-week (3 sessions/wk) evidence-based HIIT program using the roller-based system. Participants in the CG will complete an initial exercise education session and enroll in a 12-week (3 sessions/wk) independent workout program at an accessible community-based fitness facility. This study will measure the potential physiological, functional, and psychosocial health benefits of participating in a HIIT program designed for MWUs with SCI. We will then use the findings to define how exercise training at a higher intensity can support health outcomes and improve therapeutic and community-based interventions to promote cardiorespiratory and metabolic health and well-being of people with SCI.

Being tested
Roller-based Intervention Group (IG), Control Group (CG)
Keywords
manual wheelchairs, wheelchair propulsion, high intensity exercise training
Medical subject headings
Spinal Cord Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Roller-based Intervention Group (IG)Behavioural

    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.

  • Control Group (CG)Behavioural

    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.

Study groups in NCT03727893
Study groupRoleWhat they receive
Roller-based intervention Group (IG)Active comparatorA group participating in a high-intensity exercise on a roller-based system.
Receives: Behavioral: Roller-based Intervention Group (IG)
Control Group (CG)Placebo comparatorA group participating in an independent workout program at an accessible community-based fitness facility.
Receives: Behavioral: Control Group (CG)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline to Post Intervention at 4 months

  2. 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.

    Measured: Baseline to Post Intervention at 4 months

Secondary outcomes (10)

  1. Wong-Baker FACES pain scale (FACES)

    FACES is a 10-point visual-analog scale ranging from 0 (no pain) to 10 (worst pain) for participants to rate their level of pain. FACES will be administered at the beginning and end of each session, for all groups, to ensure that sessions (IG, CG) are not causing or exacerbating pain.

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

  2. PROMIS-29 Profile (v2.0) Change

    The PROMIS-29 assesses seven different domains: anxiety, depression, fatigue, pain interference, physical function, sleep disturbance, and ability to participate in social roles and activities, as well as a single pain intensity item. The seven domains are scored individually, and the single pain intensity item is reported as its raw score.

    Measured: Baseline and Post Intervention at 4 months

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

    The LTPAQ-SCI is a self-report measure of leisure time physical activity that assesses minutes of mild, moderate, and heavy intensity activity over the previous seven days.

    Measured: Baseline and Post Intervention at 4 months

  4. Wheelchair User's Shoulder Pain Index (WUSPI) Change

    The WUSPI is a self-report measure of shoulder pain in manual wheelchair users (MWUs) during functional activities. The WUSPI consists of a 15-item questionnaire addressing shoulder pain during 15 activities within four domains: transfers, wheelchair mobility, self-care, and general activities. A 10-point visual analog scale ranging from 0 (no pain) to 10 (worst pain) is used to determine pain intensity experienced during each activity. The WUSPI score (from 0 [no pain] to 150 [worst pain] across all items) indicates the participant's level of shoulder pain during functional activities.

    Measured: Baseline and Post Intervention at 4 months

  5. Wheelchair Skills Test Questionnaire (WST-Q) Change

    The WST-Q is a self-report measure of wheelchair skills. The WST-Q consists of a 34-item questionnaire addressing a MWU's capacity and performance of wheelchair skills.

    Measured: Baseline and Post Intervention at 4 months

  6. Weight Change

    Participants will be weighed during Baseline and Post Intervention assessment. Weight will be reported in kilograms.

    Measured: Baseline and Post Intervention at 4 months

  7. BMI Change

    BMI will be reported in kg/m^2

    Measured: Baseline and Post Intervention at 4 months

  8. Body Composition Overall Body Fat % Change

    Participants will then undergo body composition assessment via DEXA (General Electric Lunar iDXA), which is commonly used in research due to its precision and safety. Body fat % will be the unit of measure.

    Measured: Baseline and Post Intervention at 4 months

  9. HbA1c Level Change

    Blood draws will be completed to measure HbA1c levels in %.

    Measured: Baseline and Post Intervention at 4 months

  10. Cholesterol Change

    Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL.

    Measured: Baseline and Post Intervention at 4 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Nov 2018
  2. Study start22 Oct 2018
  3. Primary completion31 Dec 2021
  4. Study completion31 Dec 2021

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
14 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03727893
Sponsor's protocol ID
201804087
Status last verified
Feb 2022
First submitted
26 Sep 2018
Last updated
23 Feb 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

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

  • Keyser RE, Rasch EK, Finley M, Rodgers MM. Improved upper-body endurance following a 12-week home exercise program for manual wheelchair users. J Rehabil Res Dev. 2003 Nov-Dec;40(6):501-10. doi: 10.1682/jrrd.2003.11.0501.

    PubMed 15077662

  • West CR, Alyahya A, Laher I, Krassioukov A. Peripheral vascular function in spinal cord injury: a systematic review. Spinal Cord. 2013 Jan;51(1):10-9. doi: 10.1038/sc.2012.136. Epub 2012 Nov 27.

    PubMed 23184028

  • Froehlich-Grobe K, Jones D, Businelle MS, Kendzor DE, Balasubramanian BA. Impact of disability and chronic conditions on health. Disabil Health J. 2016 Oct;9(4):600-8. doi: 10.1016/j.dhjo.2016.04.007. Epub 2016 May 3.

    PubMed 27216441

  • Nightingale TE, Metcalfe RS, Vollaard NB, Bilzon JL. Exercise Guidelines to Promote Cardiometabolic Health in Spinal Cord Injured Humans: Time to Raise the Intensity? Arch Phys Med Rehabil. 2017 Aug;98(8):1693-1704. doi: 10.1016/j.apmr.2016.12.008. Epub 2017 Jan 13.

    PubMed 28089898

  • Hicks AL, Martin Ginis KA, Pelletier CA, Ditor DS, Foulon B, Wolfe DL. The effects of exercise training on physical capacity, strength, body composition and functional performance among adults with spinal cord injury: a systematic review. Spinal Cord. 2011 Nov;49(11):1103-27. doi: 10.1038/sc.2011.62. Epub 2011 Jun 7.

    PubMed 21647163

  • Carroll DD, Courtney-Long EA, Stevens AC, Sloan ML, Lullo C, Visser SN, Fox MH, Armour BS, Campbell VA, Brown DR, Dorn JM; Centers for Disease Control and Prevention (CDC). Vital signs: disability and physical activity--United States, 2009-2012. MMWR Morb Mortal Wkly Rep. 2014 May 9;63(18):407-13.

    PubMed 24807240

  • Ginis KA, Arbour-Nicitopoulos KP, Latimer AE, Buchholz AC, Bray SR, Craven BC, Hayes KC, Hicks AL, McColl MA, Potter PJ, Smith K, Wolfe DL. Leisure time physical activity in a population-based sample of people with spinal cord injury part II: activity types, intensities, and durations. Arch Phys Med Rehabil. 2010 May;91(5):729-33. doi: 10.1016/j.apmr.2009.12.028.

    PubMed 20434610

  • Sullivan KJ. President's perspectives. Healthcare Reform: a call to action for our patients. J Neurol Phys Ther. 2009 Sep;33(3):171-2. doi: 10.1097/NPT.0b013e3181b65372. No abstract available.

    PubMed 19809396

  • McCormick ZL, Lynch M, Liem B, Jacobs G, Hwang P, Hornby TG, Rydberg L, Roth E. Feasibility for developing cardiovascular exercise recommendations for persons with motor-complete paraplegia based on manual wheelchair propulsion; A protocol and preliminary data. J Spinal Cord Med. 2016;39(1):45-9. doi: 10.1179/2045772314Y.0000000292. Epub 2015 Jan 13.

    PubMed 25582138

  • Kaye, H. S., Kang, T., & LaPlante, M. P. (2000). Mobility device use in the United States. (No. 14). Washington, DC: U.S. Department of Education, National Institute on Disability and Rehabilitation Research.

  • Zwinkels M, Verschuren O, Janssen TW, Ketelaar M, Takken T; Sport-2-Stay-Fit study group; Sport-2-Stay-Fit study group. Exercise training programs to improve hand rim wheelchair propulsion capacity: a systematic review. Clin Rehabil. 2014 Sep;28(9):847-61. doi: 10.1177/0269215514525181. Epub 2014 Mar 10.

    PubMed 24615862

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

  • 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.

    PubMed 26198424

  • 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.

    PubMed 26070976

Questions about this trial

What is this clinical trial studying?

A study testing Roller-based Intervention Group (IG) in people with Spinal Cord Injuries, run by Washington University School of Medicine 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 10 inclusion and 7 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 23 Feb 2022. 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. Some participants in this study may receive a placebo. 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?

VO2peak Change (time frame: Baseline to Post Intervention at 4 months). The study lists 2 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 NCT03727893, which also lists 33 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 23 Feb 2022.

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Exercise Training and Manual Wheelchair Users With SCI | AzTrials