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.
1 other identifier
interventional
207
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Dec 2021
Longer than P75 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedStudy Start
First participant enrolled
December 1, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedNovember 15, 2021
November 1, 2021
2.1 years
September 27, 2021
November 3, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Cardiorespiratory fitness
Baseline, month 4,12, and 24.
Body composition
Baseline, month 4,12, and 24.
Blood lipids profile
Baseline, month 4,12, and 24.
Glycemia
Baseline, month 4,12, and 24.
Blood pressure
Baseline, month 4,12, and 24.
- +1 more secondary outcomes
Other Outcomes (3)
Compliance to Exercise volume prescription .
Month 4
compliance to Exercise intensity prescription.
Month 4
Daily physical activity
Month 4,12, and 24.
Study Arms (2)
conventional medical treatment
EXPERIMENTALVolunteers will maintain habitual medical treatment.
exercise training + conventional medical treatment
EXPERIMENTALVolunteers 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).
Interventions
as appear in arm description.
participants will maintain habitual medical treatment prescribed by primary care and specialized physicians from the public health service.
Eligibility Criteria
You may qualify if:
- Fulfilling criteria for metabolic syndrome diagnosis.
You may not qualify if:
- At baseline, engagement to an exercise training program for the last 6 months.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ricardo Mora-Rodriguez, PhD
University of Castilla-La Mancha
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2021
First Posted
November 15, 2021
Study Start
December 1, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2025
Last Updated
November 15, 2021
Record last verified: 2021-11
Data Sharing
- IPD Sharing
- Will not share