Clinical trial NCT05120778: Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.
Official title: Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
exercise training
healthcare cost
high-intensity interval training
strength training
Lead sponsor: University of Castilla-La Mancha
Sponsor class: OTHER
First posted: 2021-11-15
Enrollment: 207
Sex: ALL
Minimum age (years): 30
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cluster randomized clinical trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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.

Primary outcomes:
measure: Change of Annual healthcare cost
timeFrame: Baseline, month 12 and 24
Secondary outcomes:
measure: Cardiorespiratory fitness
timeFrame: Baseline, month 4,12, and 24.
measure: Body composition
timeFrame: Baseline, month 4,12, and 24.
measure: Blood lipids profile
timeFrame: Baseline, month 4,12, and 24.
measure: Glycemia
timeFrame: Baseline, month 4,12, and 24.
measure: Blood pressure
timeFrame: Baseline, month 4,12, and 24.
measure: Central obesity
timeFrame: Baseline, month 4,12, and 24.
Other outcomes:
measure: Compliance to Exercise volume prescription .
timeFrame: Month 4
measure: compliance to Exercise intensity prescription.
timeFrame: Month 4
measure: Daily physical activity
timeFrame: Month 4,12, and 24.
Locations:
Study officials:
affiliation: University of Castilla-La Mancha
name: Ricardo Mora-Rodriguez, PhD
role: PRINCIPAL_INVESTIGATOR
References: