Clinical trial NCT05318079: Telehealth Virtual Reality Exergaming for Spinal Cord Injury
Official title: Telehealth Virtual Reality Exergaming and Peer Networking Among People With Spinal Cord Injury
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Spinal Cord Injuries
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2022-04-08
Enrollment: 0
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Total play time
timeFrame: Intervention Week 1 - Week 8
measure: Total exercise time
timeFrame: Intervention Week 1 - Week 8
measure: Playtime with others
timeFrame: Intervention Week 1 - Week 8
measure: Compliance to baseline data collection
timeFrame: Week 0
measure: Compliance to post data collections
timeFrame: Week 9
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale
timeFrame: Week 0, Week 5, Week 9
measure: World Health Organization Quality of Life
timeFrame: Week 0, Week 5, Week 9
measure: Functional Grip Strength
timeFrame: Week 0, Week 5, Week 9
measure: Critical factors that affected adherence
timeFrame: Intervention Week 9
measure: Changes in blood pressure
timeFrame: Week 0, Week 5, Week 9
measure: Changes in high sensitivity C-reactive protein (hsCRP)
timeFrame: Week 0, Week 5, Week 9
measure: Changes in hemoglobin A1c
timeFrame: Week 0, Week 5, Week 9
measure: Changes in fasting insulin
timeFrame: Week 0, Week 5, Week 9
measure: Changes in fasting triglycerides
timeFrame: Week 0, Week 5, Week 9
measure: Changes in total cholesterol
timeFrame: Week 0, Week 5, Week 9
measure: Changes in low-density lipoprotein (LDL)
timeFrame: Week 0, Week 5, Week 9
measure: Changes in high-density lipoprotein (LDL)
timeFrame: Week 0, Week 5, Week 9
Other outcomes:
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