Exercise Training and Manual Wheelchair Users With SCI
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|ClinicalTrials.gov Identifier: NCT03727893|
Recruitment Status : Suspended (Temporarily paused due to COVID-19, expected to resume, IRB not suspended.)
First Posted : November 1, 2018
Last Update Posted : May 14, 2020
|Condition or disease||Intervention/treatment||Phase|
|Spinal Cord Injuries||Behavioral: Roller-based Intervention Group (IG) Behavioral: Control Group (CG)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|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 :||November 30, 2020|
|Estimated Study Completion Date :||November 30, 2020|
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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- BMI Change [ Time Frame: Baseline and Post Intervention at 4 months ]BMI will be reported in kg/m^2
- 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.
- HbA1c Level Change [ Time Frame: Baseline and Post Intervention at 4 months ]Blood draws will be completed to measure HbA1c levels in %.
- 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.
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
|United States, Missouri|
|Washington University School of Medicine|
|Saint Louis, Missouri, United States, 63108|
|Principal Investigator:||Joseph W Klaesner, PhD||Washington University School of Medicine|