FITT Exercise Counseling With Interactive Accelerometry and Physical Activity in Adolescents at Increased Risk of Early Cardiovascular Disease: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 42
- 试验地点
- 2
- 主要终点
- Physical Activity
研究概览
简要总结
This pilot study seeks to compare the change in energy expenditure and fitness levels of patients seen in the Children's Hospital Preventive Cardiology program receiving standard of care provider exercise counseling to similar patients receiving Frequency, Intensity, Time, Type (FITT) exercise prescription and counseling combined with BodyMedia supported by an online interactive tool.
The investigators primary hypothesis is that this interactive technology coupled with support from a exercise specialist will increase the energy expenditure of the investigators patients over standard of care provider counseling.
The investigators Secondary hypotheses include greater improvement in measured physical fitness Peak oxygen consumption (VO2max), oxygen consumption (VO2) at anaerobic threshold (AT) and ventilation/carbon dioxide (VE/VCO2) slope, lipid profiles, blood pressure, arterial stiffness, body mass index (BMI), BMI percentile, and self-efficacy in the intervention group compared to control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients at increased risk of atherosclerosis based on lipid profiles (Total Cholesterol > 199 mg/dL, High Density Lipoprotein < 40 mg/dL, LDL > 129 mg/dL, blood pressure (Systolic Blood Pressure or Diastolic Blood Pressure > 90th percentile), obesity (>85%Body Mass Index)
- •Ages 13-21 years
- •Reporting an average of less than 60 minutes per day of moderate to vigorous exercise most (5) days of the week.
- •Regular access to the internet with the capacity to download the device
- •Commitment on the part of a parent to supervise internet access as part of this protocol
排除标准
- •Unable to exercise based on physician recommendations or medical conditions
- •Unable/unwilling to complete requirements of the research study including consent and assent.
- •Not proficient in English
研究组 & 干预措施
Standard of Care
standard of care (office provider exercise counseling)
Intervention
The intervention group received a personalized exercise prescription (using the FITT principles) and wore an accelerometer up to 7days/week (most waking hours) and logged their activity by regularly (3 times a week) uploading the device for a period of 3 months, use of the internet was supervised by a parent or guardian. Their activity was monitored via the online BodyMedia site on a regular basis by study personnel and feedback was provided at least once a week through email and/or phone calls
干预措施: BodyMedia (Device)
结局指标
主要结局
Physical Activity
时间窗: Baseline, 3 months
Total time (minutes) in Physical Activity in one week
次要结局
- Body Mass Index(Baseline, 3 months)
研究者
Tracy Curran
Clinical Exercise Physiologist
Boston Children's Hospital