PeRsonalIzed remOtely Guided Preventive exeRcIse Therapy for a healThY Heart

NCT04745013 | Unknown DMC

• 1 other identifier: T004420N
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 3

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

Outcome Measures

Primary Outcomes (1)

• Changes in cardiorespiratory fitness

  Changes in cardiorespiratory fitness measured as pVO2 during a CPET until exhaustion

  1- and 2-year follow-up

Study Arms (2)

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.

Behavioral: PRIORITY

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.

Behavioral: Usual care

Interventions

PRIORITY BEHAVIORAL

PeRsonalIzed remOtely guided preventive exeRcIse therapy for a healThY heart

PRIORITY

Usual care BEHAVIORAL

Only a written personalized exercise prescription will be provided.

Usual care

Eligibility Criteria

• Age: 30 Years - 85 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• KU Leuven: lead
• Hasselt University: collaborator
• University Hospital, Antwerp: collaborator
• University Ghent: collaborator
• Universitaire Ziekenhuizen KU Leuven: collaborator

Study Sites (3)

UZA

Antwerp, Belgium

RECRUITING

Jessa Hospital Hasselt

Hasselt, Belgium

RECRUITING

UHasselt

Hasselt, Belgium

RECRUITING

Related Publications (1)

• 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.

  PMID: 37456813 DERIVED

MeSH Terms

Interventions

Health Priorities

Intervention Hierarchy (Ancestors)

Health Planning; Health Care Economics and Organizations; Delivery of Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Véronique Cornelissen, PhD

  KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Véronique Cornelissen, PhD

CONTACT

+32 16 3 29152; véronique.cornelissen@kuleuven.be

Youri Bekhuis, MD

CONTACT

youri.bekhuis@uzleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 4, 2021
• First Posted: February 9, 2021
• Study Start: September 1, 2021
• Primary Completion: June 1, 2024
• Study Completion: December 1, 2025
• Last Updated: December 2, 2022

Record last verified: 2022-11

Locations

BE (3)