Improving Heart Health with Virtual Gaming for Spinal Cord Injury
This study is looking at how a home-based virtual reality exercise program, called VR-Move, can help improve heart health in people with spinal cord injuries (SCI). Many individuals with SCI face challenges exercising and are at higher risk for heart problems. This study aims to find an accessible way to exercise at home. We are looking for 16 participants who are at least 18 years old, use a wheelchair for most of their movement, and are not very physically active. We will measure your aerobic capacity (how well your body uses oxygen during exercise), pain levels, and mood to see if the VR-Move program is helpful. The current recruitment status is unclear.
- Study design
- This is an interventional study planning to enroll 16 participants. It will test a virtual reality exercise program.
- What's involved
- You would exercise with the VR-Move program three times a week for 30 minutes, over a total of 12 weeks. Measurements will be taken at the beginning, at week 10, and at week 16.
- Compensation
- Not stated in the trial record.
- Follow-up
- Your aerobic capacity will be measured at the end of the 12-week intervention (16 weeks total). Pain and mood will be measured at week 10 and week 16.
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Improving Heart Health in Individuals With SCI Using Home-Based Virtual Gaming
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- aerobic capacityEnrollment to the end of the 12 week-intervention (16 weeks total)
Participants will perform a Price and Campbell upper body ergometer test, to estimate cardiorespiratory exercise capacity. The Price and Campbell upper body ergometer test is a multistage cardiorespiratory measure that begins with an initial 2-minute warm-up period of zero-Watt (W) resistance on an upper body ergometer. Following the initial warm-up period, 30 W of resistance will be applied at a crank rate of 60 rpm for 2 minutes, representing stage one of the test. All subsequent stages are progressed incrementally in 30 W intervals at 60 rpm at 2-minute intervals until volitional exhaustion. Peak cardiorespiratory capacity (VO2peak) will be measured in ml/kg body weight.
- Brief Pain InventoryWeek 10 and week 16
The Brief Pain Inventory - Short Form (BPI-sf) is a 9-item self-administered questionnaire used to evaluate the domains of severity and pain interference. Worst, least, average, and current pain intensity and rate the degree that pain interferes with general activity, mood, walking ability, normal work, relations with other persons, sleep, and enjoyment of life on a 10-point scale. A 2-point change in worst pain is considered clinically relevant.
- Patient Health Questionnaire-9 (PHQ-9)Week 10 and week 16
The PHQ-9 is a multipurpose instrument for screening, diagnosing, monitoring and measuring the severity of depression. The nine items are rated based on frequency of occurrence in the past two weeks "not at all" (0) to "everyday" (3) and summed. Total scores of 5, 10, 15, and 20 represent cut-points for mild, moderate, moderately severe and severe depression, respectively.
- • Treatment Evaluation Inventory-short form (TEI)End of intervention (Week 16)
The TEI short form is a 9-item acceptability rating scale. Each statement is rated on a five-point Likert-type scale (1= Strongly Disagree to 5= Strongly Agree). Participants answer statements regarding how reasonable the intervention will be, how likely they would implement the intervention, and how effective they believed the intervention to be
- Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)End of intervention (Week 16)
The USE measures the subjective usability of a product or service. It is a 30-item survey that examines four dimensions of usability: usefulness, ease of use, ease of learning, and satisfaction. The USE questionnaire uses 27 questions with the Likert scale (1 = strongly disagree to 7 - strongly agree), with users answering questions split into 4 domains: Usefulness (8 items, score 8-56), Ease of Use (11 items, score 11-77), Ease of Learning (4 items, score 4-27) and Satisfaction (7 items, score 7-49). Item scores will be converted to a 0-100 scale with domains averaged for a total "utility" score. The positive limit of acceptable usability of the system will be defined as 50.
- Simulator Sickness Questionnaire (SSQ)End of intervention (Week 16)
The most common reported measure of cybersickness symptoms is the Simulator Sickness Questionnaire (SSQ). The SSQ was developed to measure sickness in the context of simulation and was derived from a measure of motion sickness. Sixteen items scored 0 (none) to 3 (severe) are totaled for an overall sickness rating. Symptom severity are classified by scores such that \<5 = negligible symptoms, 5-10 = minimal symptoms, 10-15 = significant symptoms with 15-20 symptoms of concern and \>20 a "bad intervention.
- Numeric rating scale (NRS_Pain) PainFrom beginning of intervention (week 4) through end of intervention (week 16)
Participants will rate pain, on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.
- Numeric Rating Scale (NRS-Mood)From beginning of intervention (week 4) through end of intervention (week 16)
Participants will rate mood , on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.
- Numeric Rating Scale Nausea (NRS_Neausea)From beginning of intervention (week 4) through end of intervention (week 16)
Participants will rate nausea, on a 0-10 Likert scale (0 = none; 10=extreme) at beginning and end of each VR engagement (captured within the system with real-time communication to study team). Within session changes in pain, mood and nausea will be obtained during the trial. A change in pain of \>30% from baseline or 2-point decrement in mood/increase in nausea will facilitate team contact and consultation with the study physician, as needed.