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Exercise Training and Manual Wheelchair Users With SCI

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ClinicalTrials.gov Identifier: NCT03727893
Recruitment Status : Recruiting
First Posted : November 1, 2018
Last Update Posted : December 6, 2019
Sponsor:
Collaborator:
Spinal Cord Injury/Disease Research Program
Information provided by (Responsible Party):
Joseph Klaesner, Washington University School of Medicine

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).

Condition or disease Intervention/treatment Phase
Spinal Cord Injuries Behavioral: Roller-based Intervention Group (IG) Behavioral: Control Group (CG) Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Application of the WMS for Advanced Physical Training of Manual Wheelchair Users With Spinal Cord Injury
Actual Study Start Date : October 22, 2018
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Roller-based intervention Group (IG)
A group participating in a high-intensity exercise on a roller-based system.
Behavioral: Roller-based Intervention Group (IG)
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.

Placebo Comparator: Control Group (CG)
A group participating in an independent workout program at an accessible community-based fitness facility.
Behavioral: Control Group (CG)
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.




Primary Outcome Measures :
  1. VO2peak Change [ Time Frame: Baseline to Post Intervention at 4 months ]
    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.

  2. The 6-minute Push Test (6MPT) Change [ Time Frame: Baseline to Post Intervention at 4 months ]
    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.


Secondary Outcome Measures :
  1. Wong-Baker FACES pain scale (FACES) [ Time Frame: At baseline. During each intervention session. At follow up assessment. ]
    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.

  2. PROMIS-29 Profile (v2.0) Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    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.

  3. Leisure Time Physical Activity for People with Spinal Cord Injury (LTPAQ-SCI) Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    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.

  4. Wheelchair User's Shoulder Pain Index (WUSPI) Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    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.

  5. Wheelchair Skills Test Questionnaire (WST-Q) Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    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.

  6. Weight Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    Participants will be weighed during Baseline and Post Intervention assessment. Weight will be reported in kilograms.

  7. BMI Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    BMI will be reported in kg/m^2

  8. Body Composition Overall Body Fat % Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    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.

  9. HbA1c Level Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    Blood draws will be completed to measure HbA1c levels in %.

  10. Cholesterol Change [ Time Frame: Baseline and Post Intervention at 4 months ]
    Blood draws will be completed to measure cholesterol levels. Unit of measure will be in mg/dL.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03727893


Contacts
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Contact: Kimberly A Walker, OTD 314-273-7010 walker.k@wustl.edu
Contact: Kerri A Morgan, PhD 314-286-1659 morgank@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63108
Contact: Kimberly A Walker, OTD    314-273-7010    walker.k@wustl.edu   
Contact: Kerri A Morgan, PhD    314-286-1659    morgank@wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
Spinal Cord Injury/Disease Research Program
Investigators
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Principal Investigator: Joseph W Klaesner, PhD Washington University School of Medicine

Publications:
National Spinal Cord Injury Statistical Center. (2016). 2016 Annual Statistical Report - Complete Public Version. Birmingham, AL: University of Alabama at Birmingham.
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.
American College of Sports Medicine. (2014). ACSM's Guidelines for Exercise Testing and Prescription (9th ed.). Philadelphia: Lippincott Williams & Wilkins.
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.
Krueger, R. A. & Casey, M. A. (2009). Focus Groups: A Practical Guide for Applied Research (4th ed.). Thousand Oaks, CA: Sage.

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Responsible Party: Joseph Klaesner, Professor Program in Physical Therapy, Department of Radiology, Department of Biomedical Engineering, Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03727893    
Other Study ID Numbers: 201804087
First Posted: November 1, 2018    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Joseph Klaesner, Washington University School of Medicine:
manual wheelchairs
wheelchair propulsion
high intensity exercise training
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System