NCT05120778

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 207 (estimated)
• Sponsor: University of Castilla-La Mancha · Academic / Other
• Sex: All
• Age: 30 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	exercise training	as appear in arm description.
OTHER	conventional medical treatment	participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.

Timeline

• Start date: 2021-12-01
• Primary completion: 2023-12-31
• Completion: 2025-12-31
• First posted: 2021-11-15
• Last updated: 2021-11-15