PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

NCT ID: NCT04745013

Last Updated: 2022-12-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 312 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2025-12-31

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.

Conditions

Heart Failure With Preserved Ejection Fraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

PRIORITY

Intervention Type: BEHAVIORAL

PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart

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.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Only a written personalized exercise prescription will be provided.

Interventions

PRIORITY

PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart

Intervention Type: BEHAVIORAL

Usual care

Only a written personalized exercise prescription will be provided.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hasselt University

OTHER

Sponsor Role: collaborator

University Hospital, Antwerp

OTHER

Sponsor Role: collaborator

University Ghent

OTHER

Sponsor Role: collaborator

Universitaire Ziekenhuizen KU Leuven

OTHER

Sponsor Role: collaborator

KU Leuven

OTHER

Sponsor Role: lead

Responsible Party

Véronique Cornelissen

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Véronique Cornelissen, PhD

Role: PRINCIPAL_INVESTIGATOR

KU Leuven

Locations

UZA

Antwerp, , Belgium

Site Status: RECRUITING

Jessa Hospital Hasselt

Hasselt, , Belgium

Site Status: RECRUITING

UHasselt

Hasselt, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Véronique Cornelissen, PhD

Role: CONTACT

véronique.cornelissen@kuleuven.be

+32 16 3 29152

Youri Bekhuis, MD

Role: CONTACT

youri.bekhuis@uzleuven.be

Facility Contacts

Emeline Vancraenenbroeck

Role: primary

Youri Bekhuis, MD

Role: primary

Dominique Hansen, PhD

Role: primary

References

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.

Reference Type: DERIVED

PMID: 37456813 (View on PubMed)

Other Identifiers

T004420N

Identifier Type: -

Identifier Source: org_study_id