Metabolic SyndromeEXEisMEDNCT05120778
Exercise Training on Health and Medical Costs of Metabolic Syndrome Individuals.
A study testing exercise training and conventional medical treatment in people with Metabolic Syndrome, run by University of Castilla-La Mancha.
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. Read more about this study
- Who is it for?
- Ages 30 to 70 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- exercise training and conventional medical treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 207 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2021to 31 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Fulfilling criteria for metabolic syndrome diagnosis.
Who cannot join
- At baseline, engagement to an exercise training program for the last 6 months.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Metabolic Syndrome
- Being tested
- exercise training, conventional medical treatment
- Keywords
- metabolic syndrome, exercise training, healthcare cost, high-intensity interval training, strength training
- Medical subject headings
- Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
exercise trainingBehavioural
as appear in arm description.
conventional medical treatmentOther
participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.
| Study group | Role | What they receive |
|---|---|---|
| conventional medical treatment | Experimental | Volunteers will maintain habitual medical treatment. Receives: Other: conventional 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). Receives: Behavioral: exercise training; Other: conventional medical treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Baseline, month 12 and 24
Secondary outcomes (6)
Cardiorespiratory fitness
Estimation of vo2max from a graded exercise test plus a verification test
Measured: 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.
Measured: 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
Measured: Baseline, month 4,12, and 24.
Glycemia
Serum concentrations of glycemia (in mg per dL) after 8-hour fasting
Measured: 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.
Measured: 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.
Measured: Baseline, month 4,12, and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Cluster randomized clinical trial
- Masking
- None (open label)
- Enrolment
- 207 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Castilla-La Mancha
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ricardo Mora-Rodriguez, PhD, Principal investigator, University of Castilla-La Mancha
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05120778
- Sponsor's protocol ID
- 8211121078-121078-57-421
- Acronym
- EXEisMED
- Status last verified
- Nov 2021
- First submitted
- 27 Sep 2021
- Last updated
- 15 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 42115078
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Exercise Training on Health and Medical Costs of Metabolic Syndrome Factors in the Adult Population.
- ClinicalTrials.gov ID
- NCT05120778
- Acronym / sponsor ID
- EXEisMED / 8211121078-121078-57-421
- Conditions
- Metabolic Syndrome
- Keywords
- metabolic syndrome, exercise training, healthcare cost, high-intensity interval training, strength training
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 207 participants (estimated)
- Lead sponsor
- University of Castilla-La ManchaUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 15 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster randomized clinical trial
| Arm | Type | Receives |
|---|---|---|
| conventional medical treatment | Experimental | Other: conventional medical treatmentVolunteers will maintain habitual medical treatment. |
| exercise training + conventional medical treatment | Experimental | Behavioral: exercise training, Other: conventional medical treatmentVolunteers 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). |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Fulfilling criteria for metabolic syndrome diagnosis.
Key exclusion criteria (1 listed)
- At baseline, engagement to an exercise training program for the last 6 months.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| exercise trainingas appear in arm description. | Behavioural | exercise training + conventional medical treatment |
| conventional medical treatmentparticipants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service. | Other | conventional medical treatment, exercise training + conventional medical treatment |
Primary outcome
Change of Annual healthcare cost
Time frame: 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
6 secondary outcomes
Cardiorespiratory fitness
Time frame: Baseline, month 4,12, and 24.
Body composition
Time frame: Baseline, month 4,12, and 24.
Blood lipids profile
Time frame: Baseline, month 4,12, and 24.
Glycemia
Time frame: Baseline, month 4,12, and 24.
Blood pressure
Time frame: Baseline, month 4,12, and 24.
Central obesity
Time frame: Baseline, month 4,12, and 24.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2021.
- Derived from this study: PubMed 42115078Gonzalez-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ricardo Mora-Rodriguez, PhD principal investigator
University of Castilla-La Mancha
Questions about this trial
What is this clinical trial studying?
A study testing exercise training and conventional medical treatment in people with Metabolic Syndrome, run by University of Castilla-La Mancha.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Mora-Rodriguez, PhD (925268800 ext. 96843, ricardo.mora@uclm.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Annual healthcare cost (time frame: Baseline, month 12 and 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05120778, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2021.