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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Metabolic Syndrome
• Intervention / Treatment: Other: conventional medical treatment; Behavioral: exercise training

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.

• Study Type: Interventional
• Enrollment (Anticipated): 207
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Mora-Rodriguez, PhD; Phone Number: 96843 925268800; Email: ricardo.mora@uclm.es

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 28 years to 68 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Fulfilling criteria for metabolic syndrome diagnosis.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Health Services Research
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: conventional medical treatment; Volunteers will maintain habitual medical treatment.	Other: conventional medical treatment; participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.
Experimental: 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).	Other: conventional medical treatment; participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.; Behavioral: exercise training; as appear in arm description.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiorespiratory fitness	Estimation of vo2max from a graded exercise test plus a verification test	Baseline, month 4,12, and 24.
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.
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.
Glycemia	Serum concentrations of glycemia (in mg per dL) after 8-hour fasting	Baseline, month 4,12, and 24.
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.
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.

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Compliance to Exercise volume prescription .	From the exercise training sessions records (exercise time in minutes), measurement of volume prescription (Target time)	Month 4
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
Daily physical activity	Measurement of daily steps using pedometers	Month 4,12, and 24.

Collaborators and Investigators

• Sponsor: University of Castilla-La Mancha

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): December 31, 2025

Study Registration Dates

• First Submitted: September 27, 2021
• First Submitted That Met QC Criteria: November 3, 2021
• First Posted (Actual): November 15, 2021

Study Record Updates

• Last Update Posted (Actual): November 15, 2021
• Last Update Submitted That Met QC Criteria: November 3, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: strength training; exercise training; metabolic syndrome; healthcare cost; high-intensity interval training
• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Insulin Resistance; Hyperinsulinism; Syndrome; Metabolic Syndrome
• Other Study ID Numbers: 8211121078-121078-57-421

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No