Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Metabolic Syndrome
- Sponsor
- University of Castilla-La Mancha
- Enrollment
- 207
- Primary Endpoint
- Change of Annual healthcare cost
- Status
- Not Yet Recruiting
- Last Updated
- 4 years ago
Overview
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.
Investigators
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.
Outcomes
Primary Outcomes
Change of Annual healthcare cost
Time Frame: 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 Outcomes
- Blood lipids profile(Baseline, month 4,12, and 24.)
- Body composition(Baseline, month 4,12, and 24.)
- Glycemia(Baseline, month 4,12, and 24.)
- Blood pressure(Baseline, month 4,12, and 24.)
- Cardiorespiratory fitness(Baseline, month 4,12, and 24.)
- Central obesity(Baseline, month 4,12, and 24.)