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| Name | Class |
|---|---|
| Hasselt University | OTHER |
| University Hospital, Antwerp | OTHER |
| University Ghent | OTHER |
| Universitaire Ziekenhuizen KU Leuven |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PRIORITY | Experimental | 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. |
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| Usual care | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PRIORITY | Behavioral | PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart |
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| Measure | Description | Time Frame |
|---|---|---|
| Changes in cardiorespiratory fitness | Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion | 1- and 2-year follow-up |
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Inclusion Criteria: Men and women (HF stage A) aged > 30 yrs:
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
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Véronique Cornelissen, PhD | Contact | +32 16 3 29152 | véronique.cornelissen@kuleuven.be | |
| Youri Bekhuis, MD | Contact | youri.bekhuis@uzleuven.be |
| Name | Affiliation | Role |
|---|---|---|
| Véronique Cornelissen, PhD | KU Leuven | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UZA | Recruiting | Antwerp | Belgium |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37456813 | Derived | De Wilde C, Bekhuis Y, Kuznetsova T, Claes J, Claessen G, Coninx K, Decorte E, De Smedt D, Hansen D, Lannoo M, Van Craenenbroeck EM, Verhaeghe N, Cornelissen VA. Personalized remotely guided preventive exercise therapy for a healthy heart (PRIORITY): protocol for an assessor-blinded, multicenter randomized controlled trial. Front Cardiovasc Med. 2023 Jun 29;10:1194693. doi: 10.3389/fcvm.2023.1194693. eCollection 2023. |
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| ID | Term |
|---|---|
| D006292 | Health Priorities |
| ID | Term |
|---|---|
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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| OTHER |
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| Usual care | Behavioral | Only a written personalized exercise prescription will be provided. |
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| Jessa Hospital Hasselt | Recruiting | Hasselt | Belgium |
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| UHasselt | Recruiting | Hasselt | Belgium |
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