Cerebral Palsy
Conditions
Keywords
physical activity, exercise, telehealth
Brief summary
The primary purpose of this study is to examine the preliminary efficacy of 12-weeks of home-based exercise using consumer available virtual reality gaming technology, compared with a 12 week wait-list control group. The secondary purpose is to understand behavioral mechanisms that explain participation in exergaming through semi-structured interviews with participants from both groups at post-intervention or dropout.
Detailed description
Youth with cerebral palsy (YwCP) do not have adequate exercise options that empower them to independently maintain their cardiometabolic health and, thus, live inactive, sedentary lifestyles that place them at substantially higher risk for cardiovascular disease, related conditions (e.g., hypercholesterolemia, diabetes, and hypertension), and mortality than the general population. No randomized controlled trial (RCT) has demonstrated clinically meaningful improvements in cardiometabolic health in people with cerebral palsy. VR gaming delivered via telehealth may be an optimal method of promoting sustainable exercise behavior among large groups of youth. Home-based telehealth programs that incorporate 'virtual' behavioral coaching (tele-coaching) are a desirable approach for promoting non-supervised, exercise behavior among people with disabilities who do not have convenient access to community programs. The addition of behavioral coaching strategies such as goal-setting, confidence building, setting reasonable expectations, and understanding benefits, underpinned by theory such as the Social Cognitive Theory (Bandura, 2004), have been found to enhance the likelihood that people engage in and sustain a behavior. Therefore, this study hypothesizes that 3-months of tele-monitored VR exergaming with behavioral coaching will result in strong adherence to moderate-intensity exercise and greater changes in key indicators of cardiometabolic health in YwCP, compared with a wait-list control group that maintains habitual activity (before receiving the intervention).
Interventions
BEHAVIORALVirtual Reality Exergaming
The VR intervention will include home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile application. The games will include rhythmic movements to music and sport/recreation activities that elicit high energy expenditure. Participants will be instructed to reach 150 minutes per week of moderate-exercise in week 1 and maintain this volume across the 12-week intervention. The intervention will include behavioral, physical education coaching through videoconference, which we refer to as Tele-PE. Tele-PE will aim to enhance adherence, provide basic exercise knowledge, and increase mastery playing the games. Calls will last 15 minutes, and be provided weekly in month 1, bi-weekly in month 2, and one call at the end of month 3.
Sponsors
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
University of Alabama at Birmingham
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Masking description
The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
Intervention model description
One group that immediately receives the intervention. Another group that waits before receiving the same intervention.
Eligibility
Sex/Gender
ALL
Age
13 Years to 24 Years
Healthy volunteers
Yes
Inclusion criteria
1. medical diagnosis of cerebral palsy 2. between the ages of 13-24 years to accommodate the World Health Organization definition of youth and the minimum age of 13 years specified by the Quest 3. physician clearance to participate 4. access to a Wi-Fi Internet connection in the home via mobile phone or tablet computer 5. a caregiver to support the child
Exclusion criteria
1. physically active (defined as \>150 minutes per week of moderate-to-vigorous intensity exercise in a typical week) 2. cannot use their arms for exercise or a classification of GMFCS level V, which we have found to preclude the ability to use the Oculus Quest hand-held controllers 3. complete blindness or deafness. 4. contraindications to exercise based on the American College of Sports Medicine (ACSM) guidelines
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Lung Capacity | Week 0 | Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home. |
| Changes in Resting Diastolic Blood Pressure | Week 0 | 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. |
| Changes in Body Weight | Week 0 | Body weight measured in lbs using a off-the-shelf bathroom scale. |
| Changes in C-reactive Protein (hsCRP) | Week 0 | 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. |
| Changes in Hemoglobin A1C | Week 0 | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. |
| Changes in Fasting Insulin | Week 0 | 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. |
| Changes in Fasting Triglycerides | Week 0 | 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. |
| Changes in High-density Lipoprotein | Week 0 | 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. |
| Changes in Low-density Lipoprotein | Week 0 | 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. |
| Changes in Total Cholesterol | Week 0 | 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. |
| Changes in Resting Systolic Blood Pressure | Week 0 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to the Exercise Intervention Prescription | Weeks 1-12 | Percentage of moderate exercise minutes met (percent of prescription achieved), as indicated by participants in their exercise logs. The number of moderate minutes per week achieved divided by 150. Waitlist control data was not assessed for this outcome; data not collected. |
| Total Intervention Play Time | Weeks 1-12 | Total minutes of playtime recorded by mobile app and uploaded to research staff by participants. Waitlist control data was not assessed for this outcome; data not collected. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Immediate Start - Virtual Reality Exergaming 12 weeks of virtual reality active video gaming using immersive commercially available equipment, with adapted games for people to play in the seated position. Maintain normal eating/nutritional behaviors.
Virtual Reality Exergaming: The VR intervention will include home-based exercise using the Oculus Quest, a heart rate monitor (Polar OH1), BP cuff, and mobile application. The games will include rhythmic movements to music and sport/recreation activities that elicit high energy expenditure. Participants will be instructed to reach 150 minutes per week of moderate-exercise in week 1 and maintain this volume across the 12-week intervention. The intervention will include behavioral, physical education coaching through videoconference, which we refer to as Tele-PE. Tele-PE will aim to enhance adherence, provide basic exercise knowledge, and increase mastery playing the games. Calls will last 15 minutes, and be provided weekly in month 1, bi-weekly in month 2, and one call at the end of month 3. | 17 |
| Wait-list Control Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. | 15 |
| Total | 32 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Lost to Follow-up | 2 | 0 |
| Overall Study | Withdrawal by Subject | 1 | 0 |
Baseline characteristics
| Characteristic | Immediate Start - Virtual Reality Exergaming | Wait-list Control | Total |
|---|---|---|---|
| Age, Continuous | 17 years STANDARD_DEVIATION 3.7 | 16.4 years STANDARD_DEVIATION 3.8 | 16.7 years STANDARD_DEVIATION 3.7 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 17 Participants | 15 Participants | 32 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Gross Motor Function Classification System Level | 2.18 units on a scale STANDARD_DEVIATION 1.1 | 2.27 units on a scale STANDARD_DEVIATION 1.1 | 2.22 units on a scale STANDARD_DEVIATION 1.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 15 Participants | 10 Participants | 25 Participants |
| Sex: Female, Male Female | 9 Participants | 10 Participants | 19 Participants |
| Sex: Female, Male Male | 8 Participants | 5 Participants | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 17 | 0 / 15 |
| other Total, other adverse events | 1 / 17 | 0 / 15 |
| serious Total, serious adverse events | 0 / 17 | 0 / 15 |
Outcome results
Primary
Changes in Body Weight
Body weight measured in lbs using a off-the-shelf bathroom scale.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Body Weight | 127.7 lbs | Standard Deviation 42 |
| Wait-list Control | Changes in Body Weight | 128.6 lbs | Standard Deviation 36.7 |
Primary
Changes in Body Weight
Body weight measured in lbs using a off-the-shelf bathroom scale.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Body Weight | 127.9 lbs | Standard Deviation 42.3 |
| Wait-list Control | Changes in Body Weight | 128.5 lbs | Standard Deviation 35.4 |
Primary
Changes in Body Weight
Body weight measured in lbs using a off-the-shelf bathroom scale.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Body Weight | 128.1 lbs | Standard Deviation 42.5 |
| Wait-list Control | Changes in Body Weight | 129 lbs | Standard Deviation 38.4 |
Primary
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.
Time frame: Week 7
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in C-reactive Protein (hsCRP) | 2.91 mg/L | Standard Deviation 4 |
| Wait-list Control | Changes in C-reactive Protein (hsCRP) | 3.8 mg/L | Standard Deviation 3.8 |
Primary
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.
Time frame: Week 0
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in C-reactive Protein (hsCRP) | 2.32 mg/L | Standard Deviation 3.6 |
| Wait-list Control | Changes in C-reactive Protein (hsCRP) | 2.66 mg/L | Standard Deviation 3.5 |
Primary
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.
Time frame: Week 13
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in C-reactive Protein (hsCRP) | 9.1 mg/L | Standard Deviation 4.7 |
| Wait-list Control | Changes in C-reactive Protein (hsCRP) | 17.3 mg/L | Standard Deviation 18.7 |
Primary
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.
Time frame: Week 0
Population: blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Insulin | 11.3 µIU/mL | Standard Deviation 5.7 |
| Wait-list Control | Changes in Fasting Insulin | 11.6 µIU/mL | Standard Deviation 9.1 |
Primary
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.
Time frame: Week 7
Population: blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Insulin | 6.6 µIU/mL | Standard Deviation 2.4 |
| Wait-list Control | Changes in Fasting Insulin | 15.6 µIU/mL | Standard Deviation 8.5 |
Primary
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.
Time frame: Week 13
Population: blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Insulin | 9.1 µIU/mL | Standard Deviation 4.7 |
| Wait-list Control | Changes in Fasting Insulin | 17.3 µIU/mL | Standard Deviation 18.7 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Triglycerides | 90 mg/dL | Standard Deviation 29.2 |
| Wait-list Control | Changes in Fasting Triglycerides | 88.1 mg/dL | Standard Deviation 33.9 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Triglycerides | 102.1 mg/dL | Standard Deviation 57.8 |
| Wait-list Control | Changes in Fasting Triglycerides | 95.5 mg/dL | Standard Deviation 41.9 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Fasting Triglycerides | 80 mg/dL | Standard Deviation 28.4 |
| Wait-list Control | Changes in Fasting Triglycerides | 100.7 mg/dL | Standard Deviation 31.1 |
Primary
Changes in Hemoglobin A1C
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Time frame: Week 13
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Hemoglobin A1C | 4.7 mmol/mol | Standard Deviation 0.62 |
| Wait-list Control | Changes in Hemoglobin A1C | 4.55 mmol/mol | Standard Deviation 0.47 |
Primary
Changes in Hemoglobin A1C
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Time frame: Week 7
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Hemoglobin A1C | 4.68 mmol/mol | Standard Deviation 0.49 |
| Wait-list Control | Changes in Hemoglobin A1C | 4.59 mmol/mol | Standard Deviation 0.48 |
Primary
Changes in Hemoglobin A1C
HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months.
Time frame: Week 0
Population: Blood spot test
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Hemoglobin A1C | 4.51 mmol/mol | Standard Deviation 0.42 |
| Wait-list Control | Changes in Hemoglobin A1C | 4.51 mmol/mol | Standard Deviation 0.55 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in High-density Lipoprotein | 46.6 mg/dL | Standard Deviation 12.4 |
| Wait-list Control | Changes in High-density Lipoprotein | 46.7 mg/dL | Standard Deviation 10.8 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in High-density Lipoprotein | 40.5 mg/dL | Standard Deviation 9.3 |
| Wait-list Control | Changes in High-density Lipoprotein | 49.6 mg/dL | Standard Deviation 13 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in High-density Lipoprotein | 43.1 mg/dL | Standard Deviation 13 |
| Wait-list Control | Changes in High-density Lipoprotein | 46.6 mg/dL | Standard Deviation 12.9 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Low-density Lipoprotein | 117.2 mg/dL | Standard Deviation 30.7 |
| Wait-list Control | Changes in Low-density Lipoprotein | 111.9 mg/dL | Standard Deviation 32.2 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Low-density Lipoprotein | 107.3 mg/dL | Standard Deviation 25 |
| Wait-list Control | Changes in Low-density Lipoprotein | 98.8 mg/dL | Standard Deviation 24.6 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Low-density Lipoprotein | 112.8 mg/dL | Standard Deviation 29.2 |
| Wait-list Control | Changes in Low-density Lipoprotein | 103.7 mg/dL | Standard Deviation 28.8 |
Primary
Changes in Lung Capacity
Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Lung Capacity | 323.71 L/min | Standard Deviation 140 |
| Wait-list Control | Changes in Lung Capacity | 281.73 L/min | Standard Deviation 87 |
Primary
Changes in Lung Capacity
Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Lung Capacity | 359 L/min | Standard Deviation 139 |
| Wait-list Control | Changes in Lung Capacity | 291 L/min | Standard Deviation 109 |
Primary
Changes in Lung Capacity
Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Lung Capacity | 316 L/min | Standard Deviation 130 |
| Wait-list Control | Changes in Lung Capacity | 286 L/min | Standard Deviation 103 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Diastolic Blood Pressure | 71 mmHg | Standard Deviation 7.6 |
| Wait-list Control | Changes in Resting Diastolic Blood Pressure | 74.3 mmHg | Standard Deviation 8.5 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Diastolic Blood Pressure | 70.3 mmHg | Standard Deviation 8.5 |
| Wait-list Control | Changes in Resting Diastolic Blood Pressure | 70.5 mmHg | Standard Deviation 7.9 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Diastolic Blood Pressure | 71 mmHg | Standard Deviation 10.3 |
| Wait-list Control | Changes in Resting Diastolic Blood Pressure | 70.7 mmHg | Standard Deviation 7 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Systolic Blood Pressure | 104.2 mmHg | Standard Deviation 10.6 |
| Wait-list Control | Changes in Resting Systolic Blood Pressure | 111.3 mmHg | Standard Deviation 10 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Systolic Blood Pressure | 106.1 mmHg | Standard Deviation 10.9 |
| Wait-list Control | Changes in Resting Systolic Blood Pressure | 113.4 mmHg | Standard Deviation 14.8 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Resting Systolic Blood Pressure | 103.2 mmHg | Standard Deviation 13.2 |
| Wait-list Control | Changes in Resting Systolic Blood Pressure | 111.4 mmHg | Standard Deviation 14.8 |
Primary
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.
Time frame: Week 13
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Total Cholesterol | 176.8 mg/dL | Standard Deviation 39.3 |
| Wait-list Control | Changes in Total Cholesterol | 176.1 mg/dL | Standard Deviation 35.7 |
Primary
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.
Time frame: Week 7
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Total Cholesterol | 164.4 mg/dL | Standard Deviation 30.7 |
| Wait-list Control | Changes in Total Cholesterol | 168.4 mg/dL | Standard Deviation 24.3 |
Primary
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.
Time frame: Week 0
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Changes in Total Cholesterol | 179.7 mg/dL | Standard Deviation 34.7 |
| Wait-list Control | Changes in Total Cholesterol | 169.5 mg/dL | Standard Deviation 23.5 |
Secondary
Adherence to the Exercise Intervention Prescription
Percentage of moderate exercise minutes met (percent of prescription achieved), as indicated by participants in their exercise logs. The number of moderate minutes per week achieved divided by 150. Waitlist control data was not assessed for this outcome; data not collected.
Time frame: Weeks 1-12
Population: Data were analyzed from only the immediate start group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Adherence to the Exercise Intervention Prescription | 64 percentage | Standard Deviation 33 |
Secondary
Total Intervention Play Time
Total minutes of playtime recorded by mobile app and uploaded to research staff by participants. Waitlist control data was not assessed for this outcome; data not collected.
Time frame: Weeks 1-12
Population: These data were only analyzed from the immediate start group, not the control group.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Total Intervention Play Time | 144 minutes per week | Standard Deviation 73 |