Clinical trial NCT06690372: Improving Heart Health in Individuals With SCI Using Home-Based Virtual Gaming
Official title: Improving Cardiometabolic Health in Individuals With SCI Using Home-Based Interactive Virtual Gaming
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Spinal Cord Injuries (SCI)
Keywords: spinal cord injury
cardiometabolic risk
virtual reality exercise
physical activity
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2024-11-15
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A repeated measures, single group, crossover design will be used, with 16 participants. Once enrolled, participants will serve as their own control with a 4-week control phase (baseline) followed by participation in the 12-week home-based VR-Move exercise protocol (intervention phase).
Primary purpose: TREATMENT

Brief summary: What is the ultimate applicability of the research? Individuals with SCI face several challenges when trying to engage in exercise following injury. Barriers to engagement include cost, transportation, and lack of SCI accessible resources. At the same time, individuals with SCI are at risk of developing negative health consequences (e.g., cardiovascular disease) associated with physical inactivity. A critical need exists to improve relevant, accessible, and sustainable home-based exercise interventions for individuals with SCI to lower the risk of developing secondary comorbid diseases from physical inactivity and to promote wellness. This research will investigate a fun and novel in-home virtual reality system aimed toward improving physical fitness of individuals SCI with the ultimate goal of improving physical, emotional, and psychosocial quality of life. Virtual reality gaming has been used for a long time to improve physical fitness, but there have yet to be virtual reality games designed specifically for individuals with SCI. The explicit aim of this research is therefore to develop a therapeutic technology that will be widely accessible to individuals with SCI.

What persons with SCI and/or their caregivers will it help, and how will it help them? We aim to provide a readily available exercise platform for individuals with SCI, across a spectrum of physical function. Research has shown that individuals with SCI are particularly prone to be physically inactive. The consequences of physical inactivity have been well documented and include negative outcomes in physical, psychological, and social health with reduced quality of life. For the current study, we will refine our existing virtual reality exercise platform, VR-Move with a focus on non ambulatory individuals with bilaterally preserved C6 function. Our focus on using the exercise platform for this cohort of the SCI population is meant to provide a basis for developing and catering to the platform for higher levels of SCI injury (higher quadriplegic). From our previous work with virtual reality interventions in SCI, we recognize that this product can be widely used by individuals across the age spectrum independently of their home environment.

What are the potential clinical applications, benefits, and risks? The proposed virtual reality exercise platform, VR-Move, is intended to provide one of the few accessible exercise modalities designed specifically for individuals with SCI and is readily adaptable across the clinical spectrum - including clinic and self-guided home use. There are no known risks associated with this research.

How will the pilot clinical trial advance the research findings along the translational spectrum? This project aims to refine and assess timely therapeutic technology with the specific intention of translating study findings into a clinically validated, widely accessible health product that can be deployed and implemented within the home. The project likewise demonstrates collaboration between academia, industry (a veteran-owned business), and veteran SCI communities. Project completion will offer initial validation of a novel health promoting modality (i.e., virtual reality exercise) informed by individuals living with SCI and experts in SCI to be relevant and responsive to specific health/exercise needs of persons living with SCI. Larger clinical trial testing will subsequently inform product commercialization and dissemination. The resulting platform, developed for unattended in-home use, is expected to make a meaningful contribution to SCI health and physical fitness, accessibility, and quality of life.

What is the projected time it may take to achieve a person-related outcome? The team is purposefully refining the existing exercise platform, VR-Move, so that it can be easily implemented within people's homes or in clinic settings. Pending findings from the pilot clinical study, this exercise platform would be available immediately to individuals with SCI

What are the likely contributions of the proposed research project to advancing the field of SCI research, patient care, and/or quality of life? The proposed study may make significant contributions across several areas. First, it will facilitate fruitful clinical data and basic lines of scientific inquiry regarding the application of the physical activity paradigm. The study will also increase our knowledge regarding the importance of consumer advocate-driven research for individuals with SCI. Second, low-activity following SCI is consistently associated with reduced quality of life among individuals with SCI and their families; access to an inexpensive portable intervention will therefore significantly improve quality of life among those affected by low-activity SCI.

Detailed description: Overview. Cardiovascular diseases (coronary heart disease, myocardial infarction, stroke) have emerged as leading sources of illness and death for persons with spinal cord injury (SCI). Cardiometabolic disease/syndrome (CMD) is a central risk factor for both cardiovascular disease and diabetes mellitus, and encompasses a cluster of risk factors including hypertension, dyslipidemia, elevated glucose profiles, and central adiposity. In comparison to the general populations, individuals with SCI are more likely to develop CVD and are more likely to have cardiovascular disease and diabetes mellitus. The prevalence of CMD in the SCI population ranges from 33%5 and 63%, and one study found that nearly 58% of Veterans with SCI presented with CMD. Physical inactivity is associated with multiple components of CMD, including obesity, insulin resistance, hypertension, and dyslipidemia. However, while moderate intensity exercise is supported as a powerful tool against CMD over half of individuals living with SCI report no regular physical activity or exercise. Individuals with SCI are nearly 1.5 times more likely to lead sedentary lives than the general population and demonstrate significantly lower physical activity levels compared to individuals with other chronic diseases.10 Critically, everyday activities are not enough to maintain cardiovascular fitness in people with SCI, necessitating targeted exercise interventions. This "physical activity participation gap" presents a significant health crisis for individuals living with SCI and can initiate and exacerbate secondary conditions while dampening psychological well-being and quality of life (QoL). Exercise is an effective non-pharmacologic intervention to improve cardiometabolic risk factors, reduce risk for chronic and secondary conditions, and enhance psychosocial well-being. However, various barriers, such as accessibility, transportation, costs, and motivation, hinder exercise participation for those with SCI, underscoring the urgent need to provide better access to exercise experiences for this population.

Virtual reality (VR) gaming has become increasingly integrated into interventions targeting physical, neurocognitive, and psychological conditions, concurrently addressing issues like access, cost, and motivation. VR-mediated exercise interventions report strong adherence, reduced perception of effort and fatigue, and increased enjoyment of exercise participation. A global survey by the American College of Sports Medicine concluded that remote, home-based exercise, including virtual exercise, is the top fitness trend following the COVID-19 pandemic. However, while the likely benefit of home-based virtual exercise platforms for mobility impaired users is acknowledged all interventions to date have employed systems designed for able-bodied individuals. Remarkably, there has yet to be a virtual exercise platform specifically informed by input from, and exercise needs of, individuals with SCI. Further, while laboratory studies have established the potency of virtual exercise for individuals with SCI, there has yet to be a prospective study of the feasibility or cardiometabolic efficacy of a home-based virtual exercise intervention in this population. The current study assembles expertise in SCI physical health, home-based virtual reality intervention, and Lived Experience to address the abovementioned gaps by examining the feasibility and prospective efficacy of the low-cost, immersive, interactive VR exercise platform - VR-Move, deployable for self-directed use within individual homes. The project team has substantial experience and strong preliminary data supporting development and deployment of home-based immersive VR physical activity interventions for individuals with SCI. Study design is supported by a user-centered development approach (community-based participatory research) preliminary data, and a home-based technology paradigm successfully implemented by the current research team in multiple ongoing longitudinal studies with persons with SCI. The proposed study represents an important, sustainable step in promoting cardiometabolic health among people with SCI.

This proposal has integrated design elements suggested during the previous review cycle; centrally, the investigators have modified our clinical trial design with direct input from our biostatistical team to be a crossover design with a 4-week baseline control phase followed by a longer intervention phase of 12-weeks. The investigators will obtain repeated measurements at baseline (0-week), pre-intervention (4-weeks), mid-intervention (10-weeks), and post-intervention (16-weeks) which are indeed critical to understanding the longer-term impact of the intervention. The investigators have also clarified VR refinement procedures and the place of the current intervention in the larger VR pain-intervention literature. The investigators believe that these and other changes, as well as our new exciting preliminary findings, further serve to demonstrate that this novel platform has potential to meaningfully impact the health and quality of life in individuals with SCI.

Eligibility criteria: Inclusion Criteria:

* be low risk for developing a cardiovascular event during vigorous exercise according to ACSM
* be at least 18 years of age;•
* ASIA level A-D;
* wheelchair use for at least 75% of community mobility (non-ambulatory);
* report low amounts of physical activity as determined by the Physical Activity Scale for Individuals with Physical Disabilities (PASIPD). Participants whose combined scores for item 3 (moderate sport or recreation) and 4 (strenuous sport or recreation) ≤10 MET hours per week, will be considered physically inactive.

Exclusion Criteria:

* consistent or activity-exacerbated upper extremity pain of at least 4/10;
* angina or myocardial infarction within the last year, or other major barriers to upper-extremity exercise;
* inability to elevate arms above 45°,
* significant spasticity
* complete upper extremity impairment.

Primary outcomes:
measure: aerobic capacity
timeFrame: Enrollment to the end of the 12 week-intervention (16 weeks total)
measure: Brief Pain Inventory
timeFrame: Week 10 and week 16
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Week 10 and week 16
measure: • Treatment Evaluation Inventory-short form (TEI)
timeFrame: End of intervention (Week 16)
measure: Usefulness, Satisfaction, and Ease of Use Questionnaire (USE)
timeFrame: End of intervention (Week 16)
measure: Simulator Sickness Questionnaire (SSQ)
timeFrame: End of intervention (Week 16)
measure: Numeric rating scale (NRS_Pain) Pain
timeFrame: From beginning of intervention (week 4) through end of intervention (week 16)
measure: Numeric Rating Scale (NRS-Mood)
timeFrame: From beginning of intervention (week 4) through end of intervention (week 16)
measure: Numeric Rating Scale Nausea (NRS_Neausea)
timeFrame: From beginning of intervention (week 4) through end of intervention (week 16)
Secondary outcomes:
measure: Blood Pressure
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: Central Adiposity
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: Fasting blood glucose
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: Fasting blood lipid profiles
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
Other outcomes:
measure: Exercise Self Efficacy Scale (ESE)
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: SCI Quality of Life Resilience, SCIQoL_RES
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: SCI Quality of Life Positive Affect and Well-being, PAWB
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: SCI Quality of Life pain interference; SCIQoL_PI
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: Satisfaction with Life Scale (SWLS)
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
measure: General Sleep Disturbance Scale, GSDS
timeFrame: Enrollment, 4 weeks, 12 weeks and 16 weeks
Locations:
city: Philadelphia
country: United States
facility: Drexel University Health Science Building
state: Pennsylvania
Study officials:
References: