EXEisMED: Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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). |
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.
|
Outcome Measures
Primary Outcome Measures
- Change of Annual healthcare cost [Baseline, month 12 and 24]
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
Secondary Outcome Measures
- Cardiorespiratory fitness [Baseline, month 4,12, and 24.]
Estimation of vo2max from a graded exercise test plus a verification test
- Body composition [Baseline, month 4,12, and 24.]
Measurement of the mass of man body compartments (i.e., fat mass, fat free mass, and bone mass) by dual energy x-ray absorptiometry.
- Blood lipids profile [Baseline, month 4,12, and 24.]
Serum concentrations (in mg per dL) of triglycerides, total colesterol, high density lipoprotein after 8-hour fasting
- Glycemia [Baseline, month 4,12, and 24.]
Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
- Blood pressure [Baseline, month 4,12, and 24.]
Systolic and diastolic values of blood pressure measures obtained from the brachial artery after 15 min of supine rest.
- Central obesity [Baseline, month 4,12, and 24.]
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.
Other Outcome Measures
- Compliance to Exercise volume prescription . [Month 4]
From the exercise training sessions records (exercise time in minutes), measurement of volume prescription (Target time)
- compliance to Exercise intensity prescription. [Month 4]
From the exercise training sessions records (heart rate in beats per minute), measurement of compliance to exercise intensity prescription (target HR).
- Daily physical activity [Month 4,12, and 24.]
Measurement of daily steps using pedometers
Eligibility Criteria
Criteria
Inclusion Criteria:
- Fulfilling criteria for metabolic syndrome diagnosis.
Exclusion Criteria:
- At baseline, engagement to an exercise training program for the last 6 months.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- University of Castilla-La Mancha
Investigators
- Principal Investigator: Ricardo Mora-Rodriguez, PhD, University of Castilla-La Mancha
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 8211121078-121078-57-421