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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03HD107598-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immediate Start - Virtual Reality Exergaming | Experimental | 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. |
|
| Wait-list Control | No Intervention | Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Virtual Reality Exergaming | Behavioral | 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. |
| 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 |
| Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Week 0 |
| 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 |
| 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 |
| 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 |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Weeks 1-12 |
| Adherence to the Exercise Intervention Prescription |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Byron Lai, PhD | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Alabama | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35976192 | Derived | Lai B, Davis D, Young R, Kimani-Swanson E, Wozow C, Wen H, Kim Y, Wilroy J, Rimmer J. The Effects of Virtual Reality Tele-exergaming on Cardiometabolic Indicators of Health Among Youth With Cerebral Palsy: Protocol for a Pilot Randomized Controlled Trial. JMIR Res Protoc. 2022 Aug 17;11(8):e40708. doi: 10.2196/40708. |
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De-identified data will be submitted into the NICHD Data and Specimen Hub (DASH). Intellectual property and data generated under this project will be administered in accordance with both University and NIH policies, including the NIH Data Sharing Policy and Implementation Guidance under notice NOT-OD-03-032 (released February 26, 2003)
Beginning 3 months after publication and ending 5 years after publication.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | Wait-list Control | Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Children and youth with cerebral palsy
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Blood spot test | Posted | Mean | Standard Deviation | mg/L | Week 0 |
|
4 weeks
No participants had a serious adverse event. No participants were at risk for all-cause mortality, as the intensity of exercise was moderate and the participants were healthy (medically approved for exercise). The participant who had an adverse event was a unique case. He exercised in the standing position despite being prescribed to exercise in the seated position.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Foot sprain | Musculoskeletal and connective tissue disorders | Non-systematic Assessment | Participant played video game in the standing position. Due to high level of immersion, the participant kicked the wall and sprained their foot. The participant refrained from continuing the intervention for 3 weeks and withdrew. |
The study sample was not statistically powered. Thus, findings should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Byron Lai | University of Alabama at Birmingham | 205.638.9790 | 8-9725 | blai@uabmc.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 14, 2024 | Apr 25, 2025 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D002547 | Cerebral Palsy |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D001925 | Brain Damage, Chronic |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
Not provided
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| ID | Term |
|---|---|
| D000088544 | Exergaming |
| ID | Term |
|---|---|
| D015444 | Exercise |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
Not provided
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One group that immediately receives the intervention. Another group that waits before receiving the same intervention.
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The outcomes assessors will be blinded to group allocation (data entry and analysis personnel).
|
| Week 0 |
| 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 |
| 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 |
| 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 |
| Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Week 0 |
| Changes in Lung Capacity | Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home. | Week 0 |
| 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 7 |
| 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 13 |
| Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Week 7 |
| Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Week 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| 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 7 |
| 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 13 |
| Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Week 7 |
| Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Week 13 |
| Changes in Lung Capacity | Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home. | Week 7 |
| Changes in Lung Capacity | Lung capacity will be measured via peak expiratory flow rate (PEF; units: L/min) using a spirometer at the home. | Week 13 |
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. |
| Weeks 1-12 |
| Withdrawal by Subject |
|
| BG001 | Wait-list Control | Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Gross Motor Function Classification System Level | A standardized 5-level classification system designed to describe the gross motor function of individuals with cerebral palsy: Scale Range: Level I: Walks without limitations. Level II: Walks with limitations. Level III: Walks using a hand-held mobility device. Level IV: Self-mobility with limitations; may use powered mobility. Level V: Transported in a manual wheelchair; limited in ability to maintain antigravity head and trunk postures. Higher values indicate poorer mobility. | Mean | Standard Deviation | units on a scale |
|
| OG001 | Wait-list Control | Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. |
|
|
| Primary | Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Blood spot test | Posted | Mean | Standard Deviation | mmol/mol | Week 0 |
|
|
|
| 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. | blood spot test | Posted | Mean | Standard Deviation | µIU/mL | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Week 0 |
|
|
|
| Primary | Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Posted | Mean | Standard Deviation | lbs | Week 0 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | L/min | Week 0 |
|
|
|
| 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. | Blood spot test | Posted | Mean | Standard Deviation | mg/L | Week 7 |
|
|
|
| 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. | Blood spot test | Posted | Mean | Standard Deviation | mg/L | Week 13 |
|
|
|
| Primary | Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Blood spot test | Posted | Mean | Standard Deviation | mmol/mol | Week 7 |
|
|
|
| Primary | Changes in Hemoglobin A1C | HbA1C (mmol/mol) measures mean hemoglobin glycation over the previous three months. | Blood spot test | Posted | Mean | Standard Deviation | mmol/mol | Week 13 |
|
|
|
| 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. | blood spot test | Posted | Mean | Standard Deviation | µIU/mL | Week 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. | blood spot test | Posted | Mean | Standard Deviation | µIU/mL | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 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. | Posted | Mean | Standard Deviation | mg/dL | Week 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. | Posted | Mean | Standard Deviation | mg/dL | Week 7 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 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. | Posted | Mean | Standard Deviation | mg/dL | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 7 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mg/dL | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Week 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. | Posted | Mean | Standard Deviation | mmHg | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Week 7 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | mmHg | Week 13 |
|
|
|
| Primary | Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Posted | Mean | Standard Deviation | lbs | Week 7 |
|
|
|
| Primary | Changes in Body Weight | Body weight measured in lbs using a off-the-shelf bathroom scale. | Posted | Mean | Standard Deviation | lbs | Week 13 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | L/min | Week 7 |
|
|
|
| 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. | Posted | Mean | Standard Deviation | L/min | Week 13 |
|
|
|
| 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. | These data were only analyzed from the immediate start group, not the control group. | Posted | Mean | Standard Deviation | minutes per week | Weeks 1-12 |
|
|
|
| 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. | Data were analyzed from only the immediate start group. | Posted | Mean | Standard Deviation | percentage | Weeks 1-12 |
|
|
|
| 0 |
| 17 |
| 0 |
| 17 |
| 1 |
| 17 |
| EG001 | Wait-list Control | Maintain habitual physical activity levels for 12 weeks, before receiving the same intervention. Maintain normal eating/nutritional behaviors. | 0 | 15 | 0 | 15 | 0 | 15 |
|
Not provided
Not provided
| D001519 | Behavior |
| D055687 |
| Musculoskeletal and Neural Physiological Phenomena |