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

NCT ID: NCT05120778

Last Updated: 2021-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

207 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-01

Study Completion Date

2025-12-31

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.

Conditions

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Metabolic Syndrome

Keywords

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metabolic syndrome exercise training healthcare cost high-intensity interval training strength training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Cluster randomized clinical trial
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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conventional medical treatment

Volunteers will maintain habitual medical treatment.

Group Type EXPERIMENTAL

conventional medical treatment

Intervention Type OTHER

participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.

exercise training + 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).

Group Type EXPERIMENTAL

exercise training

Intervention Type BEHAVIORAL

as appear in arm description.

conventional medical treatment

Intervention Type OTHER

participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.

Interventions

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exercise training

as appear in arm description.

Intervention Type BEHAVIORAL

conventional medical treatment

participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.

Intervention Type OTHER

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.
Minimum Eligible Age

30 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Castilla-La Mancha

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ricardo Mora-Rodriguez, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Castilla-La Mancha

Central Contacts

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Ricardo Mora-Rodriguez, PhD

Role: CONTACT

Phone: 925268800

Email: [email protected]

Other Identifiers

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8211121078-121078-57-421

Identifier Type: -

Identifier Source: org_study_id