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
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
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
NCT ID
NCT05120778
First Posted
September 27, 2021
Last Updated
November 3, 2021
Sponsor
University of Castilla-La Mancha
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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