Effects of Personalized Training Program on Coronary Flow Reserve in Healthy Volunteers

Göteborg University

Status: Unknown

Conditions: Coronary Artery Disease; Heart Infarction

Treatments: Behavioral: limited physical exercise; Behavioral: physical exercise

Study type: Interventional

Funder types: Other

Identifiers

NCT02713724

GoteborgU_SSv

Details and patient eligibility

About

This study investigates whether an individualized exercise program, including a personal trainer, can improve cardiovascular status quantified with ultrasound to assess coronary flow reserve and other non-invasive techniques. The subjects in the study will be divided into two groups; one group will have a personalized exercise- and nutrition program and the other group will have acess to a gym membership, but no personal trainer.

Full description

Coronary heart disease is one of our most common diseases that causes significant morbidity and mortality. Because the risk of serious cardiovascular events, such as myocardial infarction and death, is evident in this patient population, it is of utmost importance to develop diagnostic methods to identify patients at risk. The most appropriate diagnostic methods are those that are safe to implement for both patient and physician, but also accessible and cost-efficient.

By using non-invasive techniques such as ultrasound, coronary artery function can be examined as coronary flow reserve (CFR). In the platform of non-invasive techniques used by the investigators for examinations of cardiovascular status, other methods are included, such as measurement of intima-media thickness in the carotid and radial arteries. The investigators goal is to compare the group with the personalized program with its placebo, and to compare the two study-groups with each other, to investigate whether the personalized program provides greater health benefits.

Enrollment: 60 patients

Sex: All

Ages: 35 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• non-smokers
• no current medication,
• no known diseases that require regular medication
• no known risk factor for cardiovascular disease (hypertension, hyperlipidemia, diabetes, heredity, obesity, peripheral vascular disease)
• no physically fit athletes.

Exclusion criteria

• ongoing treatment with medicine containing dipyridamole (asasantin, persantin)
• known hypersensitivity to adenosine
• chronic obstructive pulmonary disease
• atrial fibrillation or other obvious arrythmias
• AV-block grade 2 or higher
• other serious illness

Trial design

60 participants in 2 patient groups

DAPS-group

Active Comparator group

Description:

Physical exercise

Treatment:

Behavioral: physical exercise

Standard-group

Active Comparator group

Description:

Limited physical exercise

Treatment:

Behavioral: limited physical exercise