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

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).

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity; Cardiovascular Risk Factor
• Intervention / Treatment: Behavioral: Concurrent training (CT)

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Osorno
    • Los Lagos, Osorno, Chile, 000000000
      • Cristian ALvarez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years to 59 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Written informed consent
• Interested in improving health and fitness

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control group; No-exercise
Experimental: Endurance training plus resistant training; Concurrent training	Behavioral: Concurrent training (CT); 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass	Change from Baseline in body mass	Baseline and 20-weeks immediately after the interventions ends
Waist circumference	Change from Baseline in waist circumference	Baseline and 20-weeks immediately after the interventions ends
Fat mass	Change from Baseline in fat mass	Baseline and 20-weeks immediately after the interventions ends
Lean mass	Change from Baseline in lean mass	Baseline and 20-weeks immediately after the interventions ends
Heart rate at rest	Change from Baseline in heart rate at rest	Baseline and 20-weeks immediately after the interventions ends
Six minutes walking test	Change from Baseline in six minutes walking test	Baseline and 20-weeks immediately after the interventions ends

Collaborators and Investigators

• Sponsor: Universidad Santo Tomas
• Collaborators: Universidad Pública de Navarra; Universidad del Rosario; Universidad de Los Lagos; Healthcare Center Tomas Rojas
• Investigators: Principal Investigator: Cristian Alvarez, PhD, Universidad de Los Lagos

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): May 28, 2018
• Study Completion (Actual): August 25, 2018

Study Registration Dates

• First Submitted: August 28, 2018
• First Submitted That Met QC Criteria: August 29, 2018
• First Posted (Actual): August 31, 2018

Study Record Updates

• Last Update Posted (Actual): August 31, 2018
• Last Update Submitted That Met QC Criteria: August 29, 2018
• Last Verified: August 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Insulin Resistance; Hyperinsulinism; Metabolic Syndrome
• Other Study ID Numbers: 28082018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Statistical Analysis Plan

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No