Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.
- Conditions
- Metabolic Syndrome
- Interventions
- Behavioral: exercise trainingOther: conventional medical treatment
- Registration Number
- NCT05120778
- Lead Sponsor
- University of Castilla-La Mancha
- 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.
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 207
- Fulfilling criteria for metabolic syndrome diagnosis.
- At baseline, engagement to an exercise training program for the last 6 months.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description exercise training + conventional medical treatment exercise training 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). exercise training + conventional medical treatment conventional 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). conventional medical treatment conventional medical treatment Volunteers will maintain habitual medical treatment.
- Primary Outcome Measures
Name Time Method Change of Annual healthcare cost Baseline, month 12 and 24 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
Name Time Method Blood lipids profile Baseline, month 4,12, and 24. Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
Body composition Baseline, month 4,12, and 24. Measurement of the mass of man body compartments (i.e., fat mass, fat free mass, and bone mass) by dual energy x-ray absorptiometry.
Glycemia Baseline, month 4,12, and 24. Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
Blood pressure Baseline, month 4,12, and 24. Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.
Cardiorespiratory fitness Baseline, month 4,12, and 24. Estimation of vo2max from a graded exercise test plus a verification test
Central obesity Baseline, month 4,12, and 24. 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.