Effect of Monitoring Continuous Glucose Levels and Physical Activity Via Wearables on Cardiovascular Risk Factors After Cardiac Rehabilitation - A Randomised Controlled Trial: MITIGATE-RF
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in cardiovascular risk factor score HbA1c
研究概览
简要总结
The study aims to assess the effect of smart watches and continuous glucose measuring devices on cardiovascular risk factors.
详细描述
Within a period of 4 months 100 patients will be recruited and randomised to the intervention or control arm (1:1) for a duration of 3 months. Randomisation will be stratified by age, sex, BMI, diabetes, blood pressure, and duration after finishing cardiac rehabilitation. Patients randomised to the intervention arm will be given a smart watch as well as a continuous blood glucose measurement device with detailed instructions. At baseline and at the end of the study questionnaires will be answered and anthropomorphic measurements attained. Blood samples will be drawn at baseline and after an intervention period of 3 months in all subjects. Additional data on sleep, temperature, heart rate (resting and exercise), breathing rate, activity and exercise, oxygen saturation and daily weight will be collected through the Fitbit web application programming interface (API).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed Consent signed by the subject
- •Completed outpatient cardiac rehabilitation
- •Diagnosis of coronary heart disease
- •Access to a smartphone for the duration of the study
- •18 years or older on the date of consent
排除标准
- •Diseases which limit physical activity including angina with incomplete revascularisation, arrhythmogenic cardiomyopathy, stroke with residual disease, and major orthopaedic disorders
- •Known or suspected non-compliance
- •Inability to follow the procedures of the investigation, e.g., due to language problems, psychological disorders, dementia, etc. of the subject
- •Diabetic patients receiving insulin therapy
- •Lack of proficiency with smart phone/watch
- •Current participation in any other clinical trial, which may confound the results of this trial.
- •NYHA (New York Heart Association) class III or IV congestive heart failure
- •Pregnancy
结局指标
主要结局
Change in cardiovascular risk factor score HbA1c
时间窗: at baseline and after 3 month
For the risk factor HbA1c 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: DM (diabetes mellitus) HbA1c \< 7.0% or \< 6.5% in recent diagnosis No DM \< 5.7% (cut-off prediabetes) Points according to goals: 2 = \< 5.7 % 1 = 5.7 - 6.5 % 0 = \> 6.5 %
Change in cardiovascular risk factor score blood pressure
时间窗: at baseline and after 3 month
For the risk factor blood pressure 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC (European Society of Cardiology) -Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: Systolic 120-130 mmHg (18-69y.) Systolic \< 140 mmHg (70y.) Diastolic \< 80 mmHg (all ages) Points according to goals: 2 = age related SBP (systolic blood pressure) \& DBP (diastolic blood pressure) goals 1 = \< 140 mmHg, \> 130 mmHg 18-69yr. or \< 140 mmHg and \> 90 mmHg DBP \>70yr 0 = SBP \> 140 mmHg
Change in cardiovascular risk factor score LDL
时间窗: at baseline and after 3 month
For the risk factor LDL 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: LDL \<1.4 mmol/l and 50% reduction from baseline Points according to goals: 2 = \< 1.4 mmol/l 1 = \< 1.8 mmol/l 0 = \> 1.8 mmol/l
Change in cardiovascular risk factor score BMI
时间窗: at baseline and after 3 month
For the risk factor BMI 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: BMI 20-25 kg/m2 AC (Abdominal circumference) \< 102 (men) \< 88 (women) WHR (waist to hip ratio) 0.75-0.9 men \& 0.70-0.85 women Points according to goals: 2 = BMI and AC in range 1 = only BMI or AC in range 0 = nothing in range
Change in cardiovascular risk factor score smoking
时间窗: at baseline and after 3 month
For the risk factor smoking 0 or 3 points will be awarded. Points according to goals: Smoking (yes/no) 3 = no 0 = yes
Change in cardiovascular risk factor score physical activity
时间窗: at baseline and after 3 month
For the risk factor physical activity 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: \> 150min/week moderate PA (mPA), better 300min/week (self-reported) or \> 75min/week vigorous PA (vPA), better 150min/week (self-reported) Points according to goals: 2 = \> 300 min. mPA or \> 150 min. vPA 1 = \> 150 min. mPA or \> 75 min. vPA 0 = \< 150 min. mPA or \< 75 min. vPA Or mix or mPA and vPA respectively
Change in cardiovascular risk factor score nutrition
时间窗: at baseline and after 3 month
For the risk factor nutrition 0 to 2 points will be awarded. 2 points will be rewarded if the patient reaches the goals according to ESC-Guidelines where applicable, 1 point if the patient reaches the goal partially and 0 if the patient does not reach the goal. Goals according to ESC Guidelines: ≥ 5 portions fruit/vegetables a day Unsalted nuts ≥ 3x/week Reduction in saturated fats Points according to goals: 2 = 5/day OR 4/day + nuts 3x/week + reduction in saturated fats 1 = 4/day OR 3/day + nuts 3x/week + reduction in saturated fats 0 = \< 4/day
次要结局
未报告次要终点