Coronary Artery Disease, Heart Infarction
Conditions
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.
Interventions
BEHAVIORALphysical exercise
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
BEHAVIORALlimited physical exercise
The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer
Sponsors
Göteborg University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Coronary flow reserve (CFR) | 3-6 months | Ultrasound-assessed coronary flow reserve. Data will be presented as a ratio (no unit) between maximal mean hyperemia flow velocity and baseline velocity |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| endothelial function | 3-6 months | measured by EndoPath-device as RHI (reactive hyperemic index). Data will be presented as number of patients with abnormal RHI-values |
| cIMT (carotid artery intima-media thickness) | 3-6 months | carotid artery intima-media thickness, data will be presented in mm |
| metabolic biomarkers | 3-6 months | relevant metabolic blood biomarkers, data will be presented as numbers of participants with values of laboratory analyses below or above reference values |
| cardiovascular biomarkers | 3-6 months | relevant cardiovascular blood biomarkers, data will be presented as numbers of participants with values of laboratory analyses below or above reference values |
| QoL (quality of life) | 3-6 months | quality of life as measured by the validated scale PGWB (personal general well-being scale). Data will be presented as scores from the scale. |
Countries
Sweden
Outcome results
None listed