A Multicenter Exploratory Study of Accelerometry Measurements in Dilated Cardiomyopathy Patients
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- VO2max correlation with daily physical activity
研究概览
简要总结
Study evaluates the relationships between daily physical activity levels (PAL) and functional capacity (VO2peak) in patients with dilated cardiomyopathy (DCM)
详细描述
The study will evaluate the daily physical activity with the use of activity monitor, heart rate monitor and event monitor in patients with dilated cardiomyopathy (DCM). These wearables track the heart rate, heart rhythm, tracks activity and step count. The VO2 peak will be measured via the exercise test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and females, 18-75 years of age
- •Diagnosis of dilated cardiomyopathy
- •(Unexplained left ventricular enlargement (left ventricular end diastolic dimension (LVEDD) >95th percentile for gender and height by echo or MRI)
- •(Left ventricular ejection fraction (LVEF) less than 50%)
- •CPET within 14 days prior to baseline visit with no intervening change in therapy
- •Echocardiogram or cardiac MRI within 1 year prior to baseline
- •Able to walk >100ft without limitation
- •More than 30 minutes of exercise per week for at least 3 months prior to study enrollment, and plan to continue exercising for the next two weeks (duration of study).
- •Ability to provide informed consent and willingness to complete the study (including weekly phone follow-up)
排除标准
- •Heart failure hospitalization within four weeks prior to enrollment
- •Non-cardiac limitation of activity
- •Prior exercise-induced syncope or exercise-induced sudden death
- •Primary exercise mode is swimming or stationary biking
- •Participation in competitive or high intensity exercise against medical advice
- •Implantable Cardiverter Defibrillator (ICD) placement in the 2 months prior to enrollment
- •Plan for surgery, device implantation, or significant change in clinical management during the two weeks of the study
研究组 & 干预措施
Standard
All participants will perform the CPET at Baseline visit and will be provided with the Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband. The participants will be asked to response to KCCQ and Stanford 7 day recall surveys.
干预措施: Cardea SOLO (Device)
Standard
All participants will perform the CPET at Baseline visit and will be provided with the Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband. The participants will be asked to response to KCCQ and Stanford 7 day recall surveys.
干预措施: ActiGraph wGT3X-BT (Device)
Standard
All participants will perform the CPET at Baseline visit and will be provided with the Cardea SOLO, ActiGraph wGT3X-BT and Wavelet Wristband. The participants will be asked to response to KCCQ and Stanford 7 day recall surveys.
干预措施: Wavelet Wristband (Device)
结局指标
主要结局
VO2max correlation with daily physical activity
时间窗: 2 weeks
Maximal exercise capacity as measured by Max VO2 via CPET correlation with wearable device measures of daily physical activity
次要结局
- NYHA correlation with daily step count(2 weeks)
- KCCQ correlation with daily step count(2 weeks)
研究者
Matthew Wheeler
Clinical Assistant Professor
Stanford University