Overview

This trial is active, not recruiting.

Conditions coronary artery disease, heart infarction
Treatments physical exercise, limited physical exercise
Sponsor Göteborg University
Start date December 2015
End date December 2016
Trial size 60 participants
Trial identifier NCT02713724, GoteborgU_SSv

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Arm
(Active Comparator)
Physical exercise
physical exercise DAPS
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
(Active Comparator)
Limited physical exercise
limited physical exercise Standard
The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer

Primary Outcomes

Measure
Coronary flow reserve (CFR)
time frame: 3-6 months

Secondary Outcomes

Measure
endothelial function
time frame: 3-6 months
cIMT (carotid artery intima-media thickness)
time frame: 3-6 months
metabolic biomarkers
time frame: 3-6 months
cardiovascular biomarkers
time frame: 3-6 months
QoL (quality of life)
time frame: 3-6 months

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

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

Additional Information

Official title Effects of a Personalized Training Program on Trans-thoracic Adenosine-assisted Coronary Flow Reserve in Healthy Volunteers
Principal investigator Sara Svedlund, MD PhD
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Göteborg University.