Clinical trial NCT03727893: Exercise Training and Manual Wheelchair Users With SCI
Official title: Application of the WMS for Advanced Physical Training of Manual Wheelchair Users With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Spinal Cord Injuries
Keywords: manual wheelchairs
wheelchair propulsion
high intensity exercise training
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: Spinal Cord Injury/Disease Research Program
First posted: 2018-11-01
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Eligibility 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.

Primary outcomes:
measure: VO2peak Change
timeFrame: Baseline to Post Intervention at 4 months
measure: The 6-minute Push Test (6MPT) Change
timeFrame: Baseline to Post Intervention at 4 months
Secondary outcomes:
measure: Wong-Baker FACES pain scale (FACES)
timeFrame: At baseline. During each intervention session. At follow up assessment.
measure: PROMIS-29 Profile (v2.0) Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Leisure Time Physical Activity for People with Spinal Cord Injury (LTPAQ-SCI) Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Wheelchair User's Shoulder Pain Index (WUSPI) Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Wheelchair Skills Test Questionnaire (WST-Q) Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Weight Change
timeFrame: Baseline and Post Intervention at 4 months
measure: BMI Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Body Composition Overall Body Fat % Change
timeFrame: Baseline and Post Intervention at 4 months
measure: HbA1c Level Change
timeFrame: Baseline and Post Intervention at 4 months
measure: Cholesterol Change
timeFrame: Baseline and Post Intervention at 4 months
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Joseph W Klaesner, PhD
role: PRINCIPAL_INVESTIGATOR
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