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Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals. (EXEisMED)

Primary Purpose

Metabolic Syndrome

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
exercise training
conventional medical treatment
Sponsored by
University of Castilla-La Mancha
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Metabolic Syndrome focused on measuring metabolic syndrome, exercise training, healthcare cost, high-intensity interval training, strength training

Eligibility Criteria

30 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Fulfilling criteria for metabolic syndrome diagnosis.

Exclusion Criteria:

  • At baseline, engagement to an exercise training program for the last 6 months.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    conventional medical treatment

    exercise training + conventional medical treatment

    Arm Description

    Volunteers will maintain habitual medical treatment.

    Volunteers will maintain habitual medical treatment and will participate in a 16-week exercise training based on high-intensity interval training (stationary bikes), and strength training (weight-bearing exercises).

    Outcomes

    Primary Outcome Measures

    Change of Annual healthcare cost
    From unified medical records, all clinical and paraclinical interventions including pharmacological treatment, diagnostic or therapeutic procedures and primary care and specialized medical consultations will be included

    Secondary Outcome Measures

    Cardiorespiratory fitness
    Estimation of vo2max from a graded exercise test plus a verification test
    Body composition
    Measurement of the mass of man body compartments (i.e., fat mass, fat free mass, and bone mass) by dual energy x-ray absorptiometry.
    Blood lipids profile
    Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
    Glycemia
    Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
    Blood pressure
    Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.
    Central obesity
    Measurement of waist circumference (cm) in a horizontal plane, midway between the inferior margin of the ribs and the superior border of the iliac crest.

    Full Information

    First Posted
    September 27, 2021
    Last Updated
    November 3, 2021
    Sponsor
    University of Castilla-La Mancha
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05120778
    Brief Title
    Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.
    Acronym
    EXEisMED
    Official Title
    Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2021
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 1, 2021 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    December 31, 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    University of Castilla-La Mancha

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    The purpose of this study is to determine if an exercise training intervention together with conventional medical treatment can decrease the annual healthcare cost in patients with metabolic syndrome.
    Detailed Description
    It is proposed a multicentral clinical trial with cluster randomization among research nodes located in towns of Castilla-La Mancha and Toledo neighborhoods (Spain). The aim is to compare the annual healthcare cost of patients receiving conventional medical treatment against patients receiving the same intervention plus exercise training for 16 weeks. Exercise training will be based on high-intensity interval training conducted on stationary bikes, and strength training using weight-bearing exercises. Each research node will be composed of the clinical center and the sports facilities available in the town/neighborhood. Research nodes will be randomized into two experimental interventions: i.) conventional medical treatment, and ii.) conventional medical treatment + exercise training. After verbal and written information about the study and related potential risks, all patients fulfilling inclusion criteria will be included after giving written informed consent. At baseline, and after 12 and 24 months, annual healthcare costs will be obtained from the volunteers' clinical records. In addition, at baseline, and after 4, 12, and 24 months, metabolic syndrome components prevalence, metabolic syndrome z-score, body composition, and cardiorespiratory fitness will be tested.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome
    Keywords
    metabolic syndrome, exercise training, healthcare cost, high-intensity interval training, strength training

    7. Study Design

    Primary Purpose
    Health Services Research
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Model Description
    Cluster randomized clinical trial
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    207 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    conventional medical treatment
    Arm Type
    Experimental
    Arm Description
    Volunteers will maintain habitual medical treatment.
    Arm Title
    exercise training + conventional medical treatment
    Arm Type
    Experimental
    Arm Description
    Volunteers will maintain habitual medical treatment and will participate in a 16-week exercise training based on high-intensity interval training (stationary bikes), and strength training (weight-bearing exercises).
    Intervention Type
    Behavioral
    Intervention Name(s)
    exercise training
    Intervention Description
    as appear in arm description.
    Intervention Type
    Other
    Intervention Name(s)
    conventional medical treatment
    Intervention Description
    participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.
    Primary Outcome Measure Information:
    Title
    Change of Annual healthcare cost
    Description
    From unified medical records, all clinical and paraclinical interventions including pharmacological treatment, diagnostic or therapeutic procedures and primary care and specialized medical consultations will be included
    Time Frame
    Baseline, month 12 and 24
    Secondary Outcome Measure Information:
    Title
    Cardiorespiratory fitness
    Description
    Estimation of vo2max from a graded exercise test plus a verification test
    Time Frame
    Baseline, month 4,12, and 24.
    Title
    Body composition
    Description
    Measurement of the mass of man body compartments (i.e., fat mass, fat free mass, and bone mass) by dual energy x-ray absorptiometry.
    Time Frame
    Baseline, month 4,12, and 24.
    Title
    Blood lipids profile
    Description
    Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
    Time Frame
    Baseline, month 4,12, and 24.
    Title
    Glycemia
    Description
    Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
    Time Frame
    Baseline, month 4,12, and 24.
    Title
    Blood pressure
    Description
    Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.
    Time Frame
    Baseline, month 4,12, and 24.
    Title
    Central obesity
    Description
    Measurement of waist circumference (cm) in a horizontal plane, midway between the inferior margin of the ribs and the superior border of the iliac crest.
    Time Frame
    Baseline, month 4,12, and 24.
    Other Pre-specified Outcome Measures:
    Title
    Compliance to Exercise volume prescription .
    Description
    From the exercise training sessions records (exercise time in minutes), measurement of volume prescription (Target time)
    Time Frame
    Month 4
    Title
    compliance to Exercise intensity prescription.
    Description
    From the exercise training sessions records (heart rate in beats per minute), measurement of compliance to exercise intensity prescription (target HR).
    Time Frame
    Month 4
    Title
    Daily physical activity
    Description
    Measurement of daily steps using pedometers
    Time Frame
    Month 4,12, and 24.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    30 Years
    Maximum Age & Unit of Time
    70 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Fulfilling criteria for metabolic syndrome diagnosis. Exclusion Criteria: At baseline, engagement to an exercise training program for the last 6 months.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Ricardo Mora-Rodriguez, PhD
    Phone
    925268800
    Ext
    96843
    Email
    ricardo.mora@uclm.es
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ricardo Mora-Rodriguez, PhD
    Organizational Affiliation
    University of Castilla-La Mancha
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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