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

September 12, 2016 updated by: Sara Svedlund, Göteborg University

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • VG-region
      • Gothenburg, VG-region, Sweden, 413 45
        • Sahlgrenska University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: DAPS-group
Physical exercise
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
Other Names:
  • DAPS
ACTIVE_COMPARATOR: Standard-group
Limited physical exercise
Behavioral: limited physical exercise
The standard group will receive a membership at a gym but limited instructions and no access to a personal trainer
Other Names:
  • Standard

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Coronary flow reserve (CFR)
Time Frame: 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
3-6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
endothelial function
Time Frame: 3-6 months
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)
Time Frame: 3-6 months
carotid artery intima-media thickness, data will be presented in mm
3-6 months
metabolic biomarkers
Time Frame: 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
3-6 months
cardiovascular biomarkers
Time Frame: 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
3-6 months
QoL (quality of life)
Time Frame: 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.
3-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Göteborg University

Investigators

  • Principal Investigator: Sara Svedlund, MD PhD, Göteborg University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (ANTICIPATED)

December 1, 2016

Study Completion (ANTICIPATED)

December 1, 2016

Study Registration Dates

First Submitted

December 17, 2015

First Submitted That Met QC Criteria

March 15, 2016

First Posted (ESTIMATE)

March 21, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

September 13, 2016

Last Update Submitted That Met QC Criteria

September 12, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GoteborgU_SSv

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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