A Multi-center, Investigator-blinded, Randomized, 12-month, Parallel-group, Study to Compare the Clinical and Cost Efficacy of a New Hybrid Exercise Intervention PRIORITY Versus Usual Care
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- KU Leuven
- 入组人数
- 312
- 试验地点
- 3
- 主要终点
- Changes in cardiorespiratory fitness
研究概览
简要总结
In the PRIORITY study, we aim to provide the clinical evidence base for the use of a new hybrid exercise intervention, which includes remotely guided home-based exercise, as an accessible, clinical and cost-effective treatment to prevent the deleterious effects of sedentary aging on the heart and forestall the development and progression towards overt HFpEF.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 30 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men and women (HF stage A) aged > 30 yrs:
- •treated or untreated patients with hypertension (blood pressure 130/80 - 159/99 mmHg) AND/OR
- •Patients with prediabetes (impaired fasting glucose and/or insulin resistance) with either:
- •Fasting plasma glucose: 100 to 125 mg/dL (5.6-6.9 mmol/L) Hemoglobine A1c: 5.7% to 6.4% Homeostatic Model Assessment of Insulin Resistance (HOMA-IR) index above 75% of population distribution (>2.0) AND/OR
- •Patients with obesity with 30 kg/m² ≥ body mass index ≤ 42 kg/m²
- •Patients with subclinical signs of diastolic dysfunction without symptoms (HF Stage B disease)
- •Men and women with diagnosis of HF stage C: i.e. patients who have a total score ≥ 5 points according to the recent recommendation paper on how to diagnose heart failure with preserved ejection fraction from the Heart failure Association of ESC.
- •All participants should be on optimal medical treatment and stable with regard to symptoms and pharmacotherapy for at least 4 weeks before enrollment in the study. All participants should have internet access at home.
排除标准
- •significant illness during the last 6 weeks
- •known severe ventricular arrhythmia with functional or prognostic significance
- •significant myocardial ischemia, hemodynamic deterioration or exercise-induced arrhythmia at baseline testing
- •co-morbidity that may significantly negatively influence one-year prognosis
- •functional or mental disability that may limit execution of prescribed exercise
- •severe chronic obstructive pulmonary disease (FEV1 < 50%)
- •NYHA class IV
- •participation in another clinical interventional trial
- •cognitive limitation
研究组 & 干预措施
PRIORITY
Patients randomized to the hybrid exercise intervention (PRIORITY) will receive a personalized exercise prescription generated by the EXPERT tool which will then be person-tailored by the physiotherapist during one-on-one physical activity consultation. Over a period of one year, patients will participate in 18 supervised center-based exercise sessions in adjunct to a remotely monitored and guided home-based exercise intervention.
干预措施: PRIORITY (Behavioral)
Usual care
The usual care group will receive from the physiotherapist a personalized written exercise prescription that includes an individually tailored recommendation on frequency, intensity, type, time and volume of exercise. This exercise prescription will be generated by means of the EXPERT tool. No counselling or guidance on objective measures of physical activity by means of wearables or platform will be provided.
干预措施: Usual care (Behavioral)
结局指标
主要结局
Changes in cardiorespiratory fitness
时间窗: 1- and 2-year follow-up
Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion
次要结局
未报告次要终点