Targeted Healthcare Efforts to Bridge Resources, Improve the Development of Guideline-based Exercise Prescription and Reduce Obesity by Joining Education, Community, and Technology. (THE BRIDGE PROJECT - Pilot Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Changes in Cardiorespiratory Fitness
研究概览
简要总结
The purpose of this pilot study is to more effectively deliver the current standard of care for obesity and physical activity based on current guidelines. The investigators plan to gather preliminary data on physician-directed Intensive Behavioral Therapy for Obesity (IBT-O) utilizing CardioCoachCO2 by KORR technology to measure oxygen consumption both at rest and during exercise to assess resting metabolic rate (RMR) and cardiorespiratory fitness (CRF) respectively. RMR and CRF will be incorporated into an exercise prescription through implementation of the CardioCoach VO2 Max App as part of a multi-level physical activity intervention to improve CRF and decrease obesity by acting on multiple levels of the socio-ecological model in a primary care setting.
详细描述
Experimental, One-Group Pretest-Posttest study, in which current physical activity levels and cardiorespiratory fitness (CRF) will be evaluated and assessed at baseline and following 6 months of exercise conditioning. Over the course of 6 months (26 weeks) subjects will have physician based follow up appointments based on IBT-O by CMS criteria with the primary outcome of improving CRF by 1 MET, which has been associated with a 12% decrease in mortality. Secondary outcomes will include meeting changes in BMI consistent with CMS criteria of achieving a weight loss of at least 6.6 lbs (3kg) during the first six months of IBT in order to continue with IBT coverage. Progressing patients safely and efficiently toward achieving current physical activity recommendations within a sample population to guide future research on a larger scale. Through questionnaires the investigators will also gather data on Stages of Change Readiness, osteoarthritis of the knee and other weight-bearing joints, and overall Quality of Life. Subjects will be approved by their primary care physician prior to study participation. Based on American College of Sports Medicine (ACSM's) 2015 preparticipation health screening guidelines, if medical clearance is required then subjects will need to make an appointment with their PCP for exercise clearance prior to subjects' first week of participation and prior to any exercise testing. Information collected will included demographic (age, gender, race, occupation, current employment status) and co-morbid medical conditions such as hypertension, diabetes, coronary artery disease, renal disease, heart failure, etc. or any other significant illness.
On the first day of testing subjects after an overnight fast of at least 12 hours for determination of RMR through indirect calorimetry. After completing the RMR assessment, subjects will complete the following instruments: assessment of current physical activity level, Stage of Readiness to Change, personal health goals, screened by symptom assessment and physical examination for osteoarthritis of the knee and other weight-bearing joints, screening for depression and overall Quality of Life through the application of a questionnaires in a primary care setting.
On the 2nd day subjects will perform a symptom limited cardiopulmonary exercise (CPX) testing on a treadmill using a modified Balke protocol. Subjects will each be provided with their own personal heart rate monitor. The initial graded exercise test will be performed with the heart rate monitor being worn. Subjects will keep their own heart rate monitor during the study, and they will wear them during their workouts so that the app can keep them in their target heart rate zone. They will also wear the monitors during their 6 month graded exercise test. After completion of the CPX, Subjects will be instructed on how to download and utilize the CardioCoach VO2 Max app available on Smartphones which is compatible with Polar H10 Heart rate monitor system.
Subjects will be provided with access to the YMCA within their community to implement their exercise prescription.
This IBT-O model utilizing CardioCoachCO2 technology to improve physical activity, will follow the requirements developed by CMS for coverage of an IBT for Obesity
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years(Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •Any long-term disease that would interfere with their ability to exercise safely for eg Stroke with extremity weakness
- •Musculoskeletal disorder that prohibits exercise
结局指标
主要结局
Changes in Cardiorespiratory Fitness
时间窗: 6 Months
To evaluate whether exercise feedback will effect subjects' Cardiorespiratory Fitness through implementation of a proposed model of Intensive Behavioral Therapy for Obesity utilizing CardioCoachCO2, CardioCoach VO2 Max app, and H10 HR sensors to provide exercise feedback through comparison of VO2Max and VO2Peak to age and sex match norms. Statistical analysis will be performed on VO2Max,VO2Peak, and maximal MET level obtained during a graded exercise test, from baseline and following 6 months of exercise conditioning to determine if a statistically significant or clinically significant change (improvement of 1 MET) which has demonstrated a 12% decrease in all cause morality.
次要结局
- Changes in BMI(6 Months)
