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| ID | Type | Description | Link |
|---|---|---|---|
| UAB | Other Identifier | UAB |
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This phase II RCT evaluates the efficacy of a telehealth-delivered extended reality (XR) exergaming intervention on physical activity, cardiometabolic health, and physical fitness in physically inactive children with cerebral palsy (ages 10 to 17). A total of 130 participants will be randomized to either a 12-week XR exergaming intervention with behavioral coaching or a non-intervention control group, followed by a 24-week sustainability phase. Aim 1 examines immediate and sustained effects on physical activity levels. Aim 2 tests effects on cardiometabolic health indicators including blood lipids, blood pressure, and glycemic markers. Aim 3 explores effects on physical fitness and perceived health. All procedures are conducted remotely via telehealth.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Extended Reality Gaming (XRG) | Experimental | Immediate start of extended reality exercise program for 36 weeks. |
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| Non-intervention Control | No Intervention | Continue habitual activities for 36 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Extended Reality Exergaming | Behavioral | Seated arm exercise using an extended reality headset for 36 weeks. |
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| Measure | Description | Time Frame |
|---|---|---|
| Godin Leisure Time Exercise Questionnaire | The GLTEQ is a 7-day recall survey. The GLTEQ will be scored using a health contribution (HC) score, which equates an HC score of ≥24 to the minimum aerobic guideline of 150 mins/week of moderate exercise. | week 0, week 6, week 12, week 24, week 36 |
| Daily Step Count | Steps per day, captured using the Polar Unite wrist watch. | weeks 0-36 |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in C-reactive Protein (hsCRP) | hsCRP (mg/L) is a critical marker of inflammation that contributes to pro-inflammatory and pro-thrombotic elements of CVD risk. A single hsCRP measure is a strong predictor of myocardial infarction or coronary heart disease mortality, and several other diseases of the circulatory system in people without a history of such conditions. | week 0, week 6, week 12, week 24, week 36 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Byron Lai, MS, PhD | Contact | 205-638-9790 | 89725 | blai@uabmc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Byron Lai, MS, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's of Alabama | Birmingham | Alabama | 32533 | United States |
All collected IPD.
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The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
| Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Fasting Insulin | High fasting insulin indicates the presence of insulin resistance. Exercise interventions can expect a small beneficial change in fasting insulin levels after 1-month of training. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Fasting Triglycerides | A triglyceride level >150 mg/dL, is largely supported as an indicator of CVD risk. Exercise interventions can expect a small beneficial change in triglyceride levels following 1-month of training, even among people with normal triglyceride levels. | week 0, week 6, week 12, week 24, week 36 |
| Changes in High-density Lipoprotein | High-density lipoprotein (HDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Low-density Lipoprotein | Low-density lipoprotein (LDL; mg/dL) cholesterol is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Total Cholesterol | Total cholesterol (mg/dL) is a predictor of future CVD among young and middle-aged people. Exercise interventions can expect a small effect after 1-month of training. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Resting Systolic Blood Pressure | Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training. | week 0, week 6, week 12, week 24, week 36 |
| Changes in Resting Diastolic Blood Pressure | Elevated blood pressure (mmHg) during childhood and adolescents is associated with intermediate markers and hard outcomes of CVD in adulthood. Moderate-intensity exercise is negatively associated with blood pressure. Small changes in blood pressure can occur from as early as 1-month of endurance training. | week 0, week 6, week 12, week 24, week 36 |
| 2-Minute Step Test | 2 minute test is used to assess aerobic capacity by counting the number of steps an individual takes, hitting a target point, in 2 minutes. Individuals can hold on to supports for duration of the test. 2-minute step test will be for only ambulatory individuals. Higher number of steps in 2-minutes equates to higher aerobic capacity. | Week 0, Week 6, Week 12, Week 24, Week 36 |
| Timed Up and Go (TUG) | TUG is a 3-meter walking test to assess an individuals functional balance and mobility. Individuals will start in a seated position, stand, walk 3-meters turning around a cone, walk back and sit down. Time will be measured in seconds, with lower time equating to higher functional balance and mobility. | Week 0, Week 6, Week 12, Week 24, Week 36 |
| Hand-grip Strength Test (hand-held dynamometer) | Measure of isometric muscular strength of the hand and forearm. Using a hand-held dynamometer, individuals will hold onto device with arm supported at a 90 degree angle and squeeze as hard as they can for 3 seconds. Individuals will do 3 test on each hand, as able, with the average of the 3 attempt being their score. Hand-grip strength will be measured in kg, with higher values equating to more strength. | Week 0, Week 6, Week 12, Week 24, Week 36 |
| NIH PROMIS Global Health Pediatric (7 item) survey | 7-item survey assessing a child's self-reported health, including physical, mental, and social health. Each question is given a score of 1-5. The sum of all 7 questions will be used to determine the individuals total score which will be referenced to a z-score conversion table, with higher scores equating to better overall health. | Week 0, Week 6, Week 12, Week 24, Week 36 |
| Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Week 0,Week 6, Week 12, Week 24, Week 36 |
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | United States |
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| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
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