Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional medical treatment | Experimental | Volunteers will maintain habitual medical treatment. |
|
| exercise training + conventional medical treatment | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| exercise training | Behavioral | as appear in arm description. |
|
| 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 |
| 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. |
| 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. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ricardo Mora-Rodriguez, PhD | Contact | 925268800 | 96843 | ricardo.mora@uclm.es |
| Name | Affiliation | Role |
|---|---|---|
| Ricardo Mora-Rodriguez, PhD | University of Castilla-La Mancha | Principal Investigator |
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42115078 | Derived | Gonzalez-Garcia L, Moreno-Cabanas A, Mora-Gonzalez D, Mora-Rodriguez R, Morales-Palomo F. Exploring the role of successful exercise-induced body weight loss on cardiometabolic health in individuals with metabolic syndrome. Nutr Metab Cardiovasc Dis. 2026 Apr 25:104770. doi: 10.1016/j.numecd.2026.104770. Online ahead of print. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D015444 | Exercise |
| ID | Term |
|---|---|
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
Not provided
Not provided
Cluster randomized clinical trial
Not provided
Not provided
Not provided
Not provided
| conventional medical treatment | Other | participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service. |
|
| 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. |
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. |
| D009750 |
| Nutritional and Metabolic Diseases |