Effects of Personalized Training Program on Coronary Flow Reserve in Healthy Volunteers
- Conditions
- Coronary Artery DiseaseHeart Infarction
- Interventions
- Behavioral: physical exerciseBehavioral: limited physical exercise
- Registration Number
- NCT02713724
- Lead Sponsor
- Göteborg University
- 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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description DAPS-group physical exercise Physical exercise Standard-group limited physical exercise Limited physical exercise
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
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
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
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.
Trial Locations
- Locations (1)
Sahlgrenska University Hospital
🇸🇪Gothenburg, VG-region, Sweden