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

Coronary Artery Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02713724
• Other study ID #: GoteborgU_SSv
• Status: Active, not recruiting
• Phase: N/A
• First received: December 17, 2015
• Last updated: September 12, 2016
• Start date: December 2015
• Est. completion date: December 2016

Study information

• Verified date: September 2016
• Source: Göteborg University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Heart Infarction
• Infarction
• Myocardial Infarction
• Myocardial Ischemia

Intervention

Behavioral:
• physical 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
• limited physical exercise
The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg	VG-region

Sponsors (1)

Lead Sponsor	Collaborator
Göteborg University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	cIMT (carotid artery intima-media thickness)	carotid artery intima-media thickness, data will be presented in mm	3-6 months
Secondary	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
Secondary	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
Secondary	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