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

Metabolic Syndrome Clinical Trial

— EXEisMED  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05120778
• Other study ID #: 8211121078-121078-57-421
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2021
• Source: University of Castilla-La Mancha
• Contact: Ricardo Mora-Rodriguez, PhD
• Phone: 925268800
• Email: ricardo.mora[@]uclm.es
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 207
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

Inclusion Criteria:

• Fulfilling criteria for metabolic syndrome diagnosis.

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Metabolic Syndrome
• Syndrome

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Castilla-La Mancha

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Compliance to Exercise volume prescription .	From the exercise training sessions records (exercise time in minutes), measurement of volume prescription (Target time)	Month 4
Other	compliance to Exercise intensity prescription.	From the exercise training sessions records (heart rate in beats per minute), measurement of compliance to exercise intensity prescription (target HR).	Month 4
Other	Daily physical activity	Measurement of daily steps using pedometers	Month 4,12, and 24.
Primary	Change of Annual healthcare cost	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	Baseline, month 12 and 24
Secondary	Cardiorespiratory fitness	Estimation of vo2max from a graded exercise test plus a verification test	Baseline, month 4,12, and 24.
Secondary	Body composition	Measurement of the mass of man body compartments (i.e., fat mass, fat free mass, and bone mass) by dual energy x-ray absorptiometry.	Baseline, month 4,12, and 24.
Secondary	Blood lipids profile	Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting	Baseline, month 4,12, and 24.
Secondary	Glycemia	Serum concentrations of glycemia (in mg per dL) after 8-hour fasting	Baseline, month 4,12, and 24.
Secondary	Blood pressure	Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.	Baseline, month 4,12, and 24.
Secondary	Central obesity	Measurement of waist circumference (cm) in a horizontal plane, midway between the inferior margin of the ribs and the superior border of the iliac crest.	Baseline, month 4,12, and 24.