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

NCT ID: NCT02713724

Last Updated: 2016-09-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-12-31
• Study Completion Date: 2016-12-31

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.

Conditions

Coronary Artery Disease; Heart Infarction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Blinding Strategy: NONE

Study Groups

DAPS-group

Physical exercise

Group Type: ACTIVE_COMPARATOR

physical exercise

Intervention Type: 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

Standard-group

Limited physical exercise

Group Type: ACTIVE_COMPARATOR

limited physical exercise

Intervention Type: BEHAVIORAL

The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer

Interventions

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

Intervention Type: BEHAVIORAL

limited physical exercise

The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer

Intervention Type: BEHAVIORAL

Other Intervention Names

DAPS; Standard

Eligibility Criteria

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

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Göteborg University

OTHER

Sponsor Role: lead

Responsible Party

Sara Svedlund

MD PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sara Svedlund, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Göteborg University

Locations

Sahlgrenska University Hospital

Gothenburg, VG-region, Sweden

Countries

Sweden

References

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.

Reference Type: DERIVED

PMID: 29507706 (View on PubMed)

Other Identifiers

GoteborgU_SSv

Identifier Type: -

Identifier Source: org_study_id