Concurrent Training and Prediabetes Control

Concurrent Training and Prediabetes Comorbidities: An Analysis of Non-responders Using Clinical Cutoff Points

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: Metabolic Disturbance
• Intervention / Treatment: Behavioral: Endurance training plus resistant training

• 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: No
• 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, 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.

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
Active Comparator: Control group; No-exercise	Behavioral: Endurance training plus resistant training; 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.
Experimental: Endurance training plus resistant training; 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; 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.

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
Lipoproteins	Change from baseline in lipoproteins	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 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): June 10, 2017
• Primary Completion (Actual): April 9, 2018
• Study Completion (Actual): April 9, 2018

Study Registration Dates

• First Submitted: April 9, 2018
• First Submitted That Met QC Criteria: April 17, 2018
• First Posted (Actual): April 18, 2018

Study Record Updates

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

More Information

Terms related to this study

• Keywords: Obesity; Metabolic syndrome
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Prediabetic State
• Other Study ID Numbers: 9042018

Drug and device information, study documents

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