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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed 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.

Official Title
-----------------
Effects of a Personalized Training Program on Trans-thoracic Adenosine-assisted Coronary Flow Reserve in Healthy Volunteers

Conditions
-----------------
Coronary Artery Disease, Heart Infarction

Intervention / Treatment
-----------------
* Behavioral: physical exercise
* Behavioral: limited physical exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: DAPS-group<br>Physical exercise | Behavioral: physical exercise<br>* DAPS-group will follow a personal adjusted training program including instructions from a personal trainer Standard-group will receive a membership at a gym but limited instructions<br>* Other names: DAPS;|
| Active Comparator: Standard-group<br>Limited physical exercise | Behavioral: limited physical exercise<br>* The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer<br>* Other names: Standard;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coronary flow reserve (CFR) | Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| endothelial function | measured by EndoPath-device as RHI (reactive hyperemic index). Data will be presented as number of patients with abnormal RHI-values | 3-6 months | 
| cIMT (carotid artery intima-media thickness) | carotid artery intima-media thickness, data will be presented in mm | 3-6 months | 
| metabolic biomarkers | relevant metabolic blood biomarkers, data will be presented as numbers of participants with values of laboratory analyses below or above reference values | 3-6 months | 
| cardiovascular biomarkers | relevant cardiovascular blood biomarkers, data will be presented as numbers of participants with values of laboratory analyses below or above reference values | 3-6 months | 
| QoL (quality of life) | quality of life as measured by the validated scale PGWB (personal general well-being scale). Data will be presented as scores from the scale. | 3-6 months |