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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DAPS-group | Active Comparator | Physical exercise |
|
| Standard-group | Active Comparator | Limited physical exercise |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| physical exercise | Behavioral | 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 |
| 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 |
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sara Svedlund, MD PhD | Göteborg University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sahlgrenska University Hospital | Gothenburg | VG-region | 413 45 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29507706 | Derived | Westergren HU, Gan LM, Mansson M, Svedlund S. Randomized clinical trial studying effects of a personalized supervised lifestyle intervention program on cardiovascular status in physically inactive healthy volunteers. Oncotarget. 2018 Jan 3;9(10):9498-9511. doi: 10.18632/oncotarget.23958. eCollection 2018 Feb 6. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Sep 20, 2016 | |
| Reset | Nov 7, 2016 | |
| Release | Apr 8, 2025 | |
| Reset | Apr 24, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 20, 2016 | Nov 7, 2016 | |||
| Apr 8, 2025 |
| ID | Term |
|---|---|
| D003324 | Coronary Artery Disease |
| D009203 | Myocardial Infarction |
| ID | Term |
|---|---|
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D015444 | Exercise |
| C041756 | alpha,beta-diacryloxypropionic acid |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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|
| limited physical exercise | Behavioral | The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer |
|
|
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 |
| Apr 24, 2025 |
| D001161 |
| Arteriosclerosis |
| D001157 | Arterial Occlusive Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |