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

Sponsor
Göteborg University (Other)
Overall Status
Unknown status
CT.gov ID
NCT02713724
Collaborator
(none)
60
Enrollment
1
Location
2
Arms
12
Duration (Months)
5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: physical exercise
  • Behavioral: limited physical exercise
 N/A

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 Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Official Title:
Effects of a Personalized Training Program on Trans-thoracic Adenosine-assisted Coronary Flow Reserve in Healthy Volunteers
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Dec 1, 2016
Anticipated Study Completion Date :
Dec 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Coronary flow reserve (CFR) [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

    Secondary Outcome Measures

    1. endothelial function [3-6 months]

      measured by EndoPath-device as RHI (reactive hyperemic index). Data will be presented as number of patients with abnormal RHI-values

    2. cIMT (carotid artery intima-media thickness) [3-6 months]

      carotid artery intima-media thickness, data will be presented in mm

    3. metabolic biomarkers [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

    4. cardiovascular biomarkers [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

    5. QoL (quality of life) [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    35 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Sahlgrenska University Hospital Gothenburg VG-region Sweden 413 45

    Sponsors and Collaborators

    • Göteborg University

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Sara Svedlund, MD PhD, Göteborg University
    ClinicalTrials.gov Identifier:
    NCT02713724
    Other Study ID Numbers:
    • GoteborgU_SSv
    First Posted:
    Mar 21, 2016
    Last Update Posted:
    Sep 13, 2016
    Last Verified:
    Sep 1, 2016
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Additional relevant MeSH terms:
    Coronary Artery Disease
    Infarction

    Study Results

    No Results Posted as of Sep 13, 2016