Spinal Cord Injuries
Conditions
Brief summary
This pilot feasibility study aims to test whether youth and adults with spinal cord injury can use a group virtual reality gaming intervention to exercise. A second purpose is to examine whether there are potential benefits to cardiometabolic health and psychosocial health.
Detailed description
There are three purposes to this study. The first purpose is to quantify feasibility through telemonitored exercise data: total play time, moderate exercise time, playtime with others, and compliance to the data collections. These variables will be compared against a priori criteria for acceptability. These variables will help determine whether modifications to the intervention protocol are necessary. The second purpose is to qualitatively interview participants to explain underlying behavioral mechanisms that affect their participation in the program. This information will be used to explain how to improve implementation issues identified in Aim 1. The third aim is to explore the potential effects of the program on self-reported psychosocial health and quality of life, hand-grip strength, and cardiometabolic health (blood cholesterol, lipids, pressure, and insulin) measured via home dried blood spot test.
Interventions
BEHAVIORALVirtual Reality Gaming
Peer-to-peer gaming.
Sponsors
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* medical diagnosis of traumatic spinal cord injury (determined by International Classification of Disease \[ICD\] codes) * a caregiver to support the participant if the participant is a child (\<18 years of age) * access to a Wi-Fi Internet connection in the home
Exclusion criteria
* physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) * cannot use the arms for exercise or operate the controller buttons using their fingers * complete blindness or deafness * recent myocardial infarction or electrocardiography changes, complete heart block, acute congestive heart failure, unstable angina, and uncontrolled severe hypertension \[BP \>/= 180/110 mmHg\] * prone to seizures
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total play time | Intervention Week 1 - Week 8 | Percentage of the 300 minutes of prescribed play per week across the intervention. |
| Total exercise time | Intervention Week 1 - Week 8 | Moderate exercise minutes where prescription was met (percent of prescription achieved: weeks where the ≥90 minutes of moderate intensity exercise per week was achieved across the intervention, divided by total weeks). |
| Playtime with others | Intervention Week 1 - Week 8 | Measured by the number of play sessions with other players (online multiplayer and/or peer-gaming). This number will be totaled across the 8-week intervention and divided by 16 (the exercise prescription of 2 x per week of multiplayer gaming). |
| Compliance to baseline data collection | Week 0 | Number of pre data collections completed, converted into a percentage dividing by the total possible. |
| Compliance to post data collections | Week 9 | Number of pre data collections completed, converted into a percentage dividing by the total possible. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in high sensitivity C-reactive protein (hsCRP) | Week 0, Week 5, Week 9 | Changes in high sensitivity C-reactive protein measured via blood spot test across the intervention. |
| Changes in hemoglobin A1c | Week 0, Week 5, Week 9 | Changes in hemoglobin A1c measured via blood spot test across the intervention. |
| Changes in fasting insulin | Week 0, Week 5, Week 9 | Changes in fasting insulin levels measured via blood spot test across the intervention. |
| Hospital Anxiety and Depression Scale | Week 0, Week 5, Week 9 | The Hospital Anxiety and Depression Scale is a 14-item self-report measure that provides separate scores for anxiety and depression. Hospital Anxiety and Depression Scale is a common clinical measure that has strong psychometric properties. Scores range from 0 to 42, where a higher score represents a worse level of depression. |
| Changes in total cholesterol | Week 0, Week 5, Week 9 | Changes in total cholesterol measured via blood spot test across the intervention. |
| Changes in low-density lipoprotein (LDL) | Week 0, Week 5, Week 9 | Changes in low-density lipoprotein via blood spot test across the intervention. |
| Changes in high-density lipoprotein (LDL) | Week 0, Week 5, Week 9 | Changes in high-density lipoprotein via blood spot test across the intervention. |
| Changes in fasting triglycerides | Week 0, Week 5, Week 9 | Changes in fasting triglycerides levels measured via blood spot test across the intervention. |
| World Health Organization Quality of Life | Week 0, Week 5, Week 9 | The World Health Organization Quality of Life is a self-report questionnaire with 26 items that cover 5 dimensions: physical health (7 items); psychological health (6 items); social relationships (3 items); environment (8 items); and overall quality of life (2 items). Raw scores are calculated for each domain on a lilkert scale of 1-5 (low domain score of 3, max domain raw score of 40. Raw scores are then multiplied by 4 to transform the raw score into a scaled score. Higher scores represent higher perceived ratings of quality of life. |
| Functional Grip Strength | Week 0, Week 5, Week 9 | Grip strength will be measured as an indicator of global muscular strength, using a low-cost hand-held dynamometer. |
| Critical factors that affected adherence | Intervention Week 9 | Participants will undergo one-on-one, semi-structured interviews after the intervention to identify critical factors that affected their participation to the intervention. |
| Changes in blood pressure | Week 0, Week 5, Week 9 | Changes in resting home-blood pressure (systolic and diastolic ) measured via blood pressure cuff across the intervention. |
Outcome results
None listed