Exercise Training and Manual Wheelchair Users With SCI

February 21, 2022 updated by: Joseph Klaesner, Washington University School of Medicine

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

14

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63108
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Post Intervention at 4 months
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.
Baseline to Post Intervention at 4 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At baseline. During each intervention session. At follow up assessment.
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.
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months
BMI Change
Time Frame: Baseline and Post Intervention at 4 months
BMI will be reported in kg/m^2
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months
HbA1c Level Change
Time Frame: Baseline and Post Intervention at 4 months
Blood draws will be completed to measure HbA1c levels in %.
Baseline and Post Intervention at 4 months
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.
Baseline and Post Intervention at 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Collaborators

Spinal Cord Injury/Disease Research Program

Investigators

  • Principal Investigator: Joseph W Klaesner, PhD, Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2018

Primary Completion (Actual)

December 31, 2021

Study Completion (Actual)

December 31, 2021

Study Registration Dates

First Submitted

September 26, 2018

First Submitted That Met QC Criteria

October 31, 2018

First Posted (Actual)

November 1, 2018

Study Record Updates

Last Update Posted (Actual)

February 23, 2022

Last Update Submitted That Met QC Criteria

February 21, 2022

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201804087

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Spinal Cord Injuries

Clinical Trials on Roller-based Intervention Group (IG)

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Bosnia & Herzegovina

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe