Back to results

Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians

Primary Purpose

Obesity, Cardiovascular Risk Factor, Physical Activity

Status

Completed

Phase

Not Applicable

Locations

Chile

Study Type

Interventional

Intervention

Concurrent training (CT)

About this trial

This is an interventional prevention trial for Obesity

Eligibility Criteria

30 Years - 59 Years (Adult)FemaleAccepts Healthy Volunteers

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.

Sites / Locations

Cristian Alvarez

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

Endurance training plus resistant training

Arm Description

No-exercise

Concurrent training

Outcomes

Primary Outcome Measures

Fasting glucose

Change from Baseline in fasting glucose

Total cholesterol

Change from baseline in Total cholesterol

Blood pressure

Change from baseline in Blood pressure

Secondary Outcome Measures

Body mass

Change from Baseline in body mass

Waist circumference

Change from Baseline in waist circumference

Fat mass

Change from Baseline in fat mass

Lean mass

Change from Baseline in lean mass

Heart rate at rest

Change from Baseline in heart rate at rest

Six minutes walking test

Change from Baseline in six minutes walking test

Full Information

NCT ID

NCT03653468

First Posted

August 28, 2018

Last Updated

August 29, 2018

Sponsor

Universidad Santo Tomas

Collaborators

Universidad del Rosario, Universidad Pública de Navarra, Healthcare Center Tomas Rojas, Universidad de Los Lagos

1. Study Identification

Unique Protocol Identification Number

NCT03653468

Brief Title

Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians

Official Title

Similar Improvements in Cardiometabolic Risk Factors for Preventing the Metabolic Syndrome in Latinoamerican Amerindians After 12-weeks of Concurrent Training

Study Type

Interventional

2. Study Status

Record Verification Date

August 2018

Overall Recruitment Status

Completed

Study Start Date

January 1, 2018 (Actual)

Primary Completion Date

May 28, 2018 (Actual)

Study Completion Date

August 25, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Universidad Santo Tomas

Collaborators

Universidad del Rosario, Universidad Pública de Navarra, Healthcare Center Tomas Rojas, Universidad de Los Lagos

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Cardiovascular Risk Factor, Physical Activity

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Behavioral

Masking

Investigator

Allocation

Randomized

Enrollment

28 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control group

Arm Type

No Intervention

Arm Description

No-exercise

Arm Title

Endurance training plus resistant training

Arm Type

Experimental

Arm Description

Concurrent training

Intervention Type

Behavioral

Intervention Name(s)

Concurrent training (CT)

Intervention Description

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.

Primary Outcome Measure Information:

Title

Fasting glucose

Description

Change from Baseline in fasting glucose

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Total cholesterol

Description

Change from baseline in Total cholesterol

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Blood pressure

Description

Change from baseline in Blood pressure

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Secondary Outcome Measure Information:

Title

Body mass

Description

Change from Baseline in body mass

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Waist circumference

Description

Change from Baseline in waist circumference

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Fat mass

Description

Change from Baseline in fat mass

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Lean mass

Description

Change from Baseline in lean mass

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Heart rate at rest

Description

Change from Baseline in heart rate at rest

Time Frame

Baseline and 20-weeks immediately after the interventions ends

Title

Six minutes walking test

Description

Change from Baseline in six minutes walking test

Time Frame

Baseline and 20-weeks immediately after the interventions ends

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

30 Years

Maximum Age & Unit of Time

59 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Cristian Alvarez, PhD

Organizational Affiliation

Universidad de Los Lagos

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cristian Alvarez

City

Los Lagos

State/Province

Osorno

ZIP/Postal Code

000000000

Country

Chile

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Statistical Analysis Plan

Learn more about this trial

Exercise for Preventing the Metabolic Syndrome in Latinoamerican Amerindians

We'll reach out to this number within 24 hrs