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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- KU Leuven
- Enrollment
- 312
- Locations
- 3
- Primary Endpoint
- Changes in cardiorespiratory fitness
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 30 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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
Arms & Interventions
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.
Intervention: 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.
Intervention: Usual care (Behavioral)
Outcomes
Primary Outcomes
Changes in cardiorespiratory fitness
Time Frame: 1- and 2-year follow-up
Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion
Secondary Outcomes
No secondary outcomes reported
Investigators
Véronique Cornelissen
Professor
KU Leuven