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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: exercise training
* Other: conventional medical treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Fulfilling criteria for metabolic syndrome diagnosis. Exclusion Criteria: At baseline, engagement to an exercise training program for the last 6 months.

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cluster randomized clinical trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: conventional medical treatment<br>Volunteers will maintain habitual medical treatment. | Other: conventional medical treatment<br>* participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.<br>|
| Experimental: exercise training + conventional medical treatment<br>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). | Behavioral: exercise training<br>* as appear in arm description.<br>Other: conventional medical treatment<br>* participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Baseline, month 12 and 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory fitness | Estimation of vo2max from a graded exercise test plus a verification test | Baseline, month 4,12, and 24. | 
| 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. | Baseline, month 4,12, and 24. | 
| Blood lipids profile | Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting | Baseline, month 4,12, and 24. | 
| Glycemia | Serum concentrations of glycemia (in mg per dL) after 8-hour fasting | Baseline, month 4,12, and 24. | 
| Blood pressure | Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest. | Baseline, month 4,12, and 24. | 
| 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. | Baseline, month 4,12, and 24. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic syndrome, exercise training, healthcare cost, high-intensity interval training, strength training