NCT03653468

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable obesity

Timeline
Completed

Started Jan 2018

Shorter than P25 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
completed

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

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2018

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

August 28, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 31, 2018

Completed
Last Updated

August 31, 2018

Status Verified

August 1, 2018

Enrollment Period

5 months

First QC Date

August 28, 2018

Last Update Submit

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 INTERVENTION

No-exercise

Endurance training plus resistant training

EXPERIMENTAL

Concurrent training

Behavioral: Concurrent training (CT)

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.

Endurance training plus resistant training

Eligibility Criteria

Age30 Years - 59 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

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

Study Sites (1)

Cristian Alvarez

Los Lagos, Osorno, 000000000, Chile

Location

MeSH Terms

Conditions

ObesityMotor Activity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBehavior

Study Officials

  • Cristian Alvarez, PhD

    Universidad de Los Lagos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: Behavioral
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

Locations