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

University of Castilla-La Mancha

Status: Not yet enrolling

Conditions: Metabolic Syndrome

Treatments: Other: conventional medical treatment; Behavioral: exercise training

Study type: Interventional

Funder types: Other

Identifiers

NCT05120778

8211121078-121078-57-421

Details and patient eligibility

About

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.

Full 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.

Enrollment: 207 estimated patients

Sex: All

Ages: 30 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Fulfilling criteria for metabolic syndrome diagnosis.

Exclusion criteria

• At baseline, engagement to an exercise training program for the last 6 months.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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207 participants in 2 patient groups

conventional medical treatment

Experimental group

Description:

Volunteers will maintain habitual medical treatment.

Treatment:

Other: conventional medical treatment

exercise training + conventional medical treatment

Experimental group

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).

Treatment:

Other: conventional medical treatment

Behavioral: exercise training