Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians
Similar Improvements in Cardiometabolic Risk Factors for Preventing the Metabolic Syndrome in Latinoamerican Amerindians After 12-weeks of Concurrent Training
1 other identifier
interventional
28
1 country
1
Brief Summary
Despite exercise training decrease blood fasting glicaemy in 'average' terms, there is a wide inter-individual variability after exercise training explored mainly in adults but not in adults with prediabetes comorbidities. Thus, is yet unknown the effects and influence of the concurrent training (CT) eliciting responders (R) and non-responders (NR) cases (i.e., percentage of subjects who experienced a non-change/worsened response after training in some metabolic outcomes).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Jan 2018
Shorter than P25 for not_applicable obesity
1 active site
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
Study Start
First participant enrolled
January 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 28, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
August 25, 2018
CompletedFirst Submitted
Initial submission to the registry
August 28, 2018
CompletedFirst Posted
Study publicly available on registry
August 31, 2018
CompletedAugust 31, 2018
August 1, 2018
5 months
August 28, 2018
August 29, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
Fasting glucose
Change from Baseline in fasting glucose
Baseline and 20-weeks immediately after the interventions ends
Total cholesterol
Change from baseline in Total cholesterol
Baseline and 20-weeks immediately after the interventions ends
Blood pressure
Change from baseline in Blood pressure
Baseline and 20-weeks immediately after the interventions ends
Secondary Outcomes (6)
Body mass
Baseline and 20-weeks immediately after the interventions ends
Waist circumference
Baseline and 20-weeks immediately after the interventions ends
Fat mass
Baseline and 20-weeks immediately after the interventions ends
Lean mass
Baseline and 20-weeks immediately after the interventions ends
Heart rate at rest
Baseline and 20-weeks immediately after the interventions ends
- +1 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONNo-exercise
Endurance training plus resistant training
EXPERIMENTALConcurrent training
Interventions
The core part of each session included resistance training (RT) followed by aerobic training exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.
Eligibility Criteria
You may qualify if:
- Written informed consent
- Interested in improving health and fitness
You may not qualify if:
- Cardiovascular contraindications to exercise
- History of stroke, asthma or chronic obstructive pulmonary disease, muscle-skeletal disorders
- Smoking
- A compliance rate to the exercise program ≥ 70% was required for the participants in the intervention group to be included in the statistical analyses.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad Santo Tomaslead
- Universidad del Rosariocollaborator
- Universidad Pública de Navarracollaborator
- Healthcare Center Tomas Rojascollaborator
- Universidad de Los Lagoscollaborator
Study Sites (1)
Cristian Alvarez
Los Lagos, Osorno, 000000000, Chile
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Cristian Alvarez, PhD
Universidad de Los Lagos
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2018
First Posted
August 31, 2018
Study Start
January 1, 2018
Primary Completion
May 28, 2018
Study Completion
August 25, 2018
Last Updated
August 31, 2018
Record last verified: 2018-08
Data Sharing
- IPD Sharing
- Will not share
Statistical Analysis Plan