NCT03502304

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

Timeline
Completed

Started Jun 2017

Shorter than P25 for not_applicable

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

June 10, 2017

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 9, 2018

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 9, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 9, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 18, 2018

Completed
Last Updated

May 31, 2018

Status Verified

May 1, 2018

Enrollment Period

10 months

First QC Date

April 9, 2018

Last Update Submit

May 29, 2018

Conditions

Metabolic Disturbance

Keywords

Metabolic syndromeObesity

Outcome Measures

Primary Outcomes (2)

  • Fasting glucose

    Change from Baseline in fasting glucose

    Baseline and 20-weeks immediately after the interventions ends

  • Lipoproteins

    Change from baseline in lipoproteins

    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

ACTIVE COMPARATOR

No-exercise

Behavioral: Endurance training plus resistant training

Endurance training plus resistant training

EXPERIMENTAL

To concurrent training (endurance training plus resistant training, RT) program will be use cycle ergometers adapted for obese adults (OXFORDTM, model BE2601, OXOFORD Inc, Santiago, Chile) were used. Prior to the CT intervention, all subjects were familiarized (during 3 sessions) with the training protocols. The CT intervention included 3 weekly sessions of both ET and RT. The core part of each session included RT followed by ET exercises (for 50 and 30 minutes, respectively) and was preceded and followed by a 5-minute warm-up and cool-down with callisthenic movements.

Behavioral: Endurance training plus resistant training

Interventions

Endurance training plus resistant trainingBEHAVIORAL

CT in women with prediabetes and co-morbidities associated. Exercise will be performed at three sessions per week. Post statistical analyses will be including analyses by the 2 groups proposed. All sessions will be supervised by an exercise physiologist during 20-weeks.

Control groupEndurance 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, and
  • 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

Metabolic SyndromeObesity

Interventions

Endurance Training

Condition Hierarchy (Ancestors)

Insulin ResistanceHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Exercise TherapyRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsPhysical Therapy ModalitiesPhysical Conditioning, HumanExerciseMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

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

April 9, 2018

First Posted

April 18, 2018

Study Start

June 10, 2017

Primary Completion

April 9, 2018

Study Completion

April 9, 2018

Last Updated

May 31, 2018

Record last verified: 2018-05

Locations

CL(1)