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Resistance Training in Patients With Morbid Obesity (ExinMO)

Primary Purpose

Morbid Obesity, Obesity, Physical Activity

Status
Completed
Phase
Not Applicable
Locations
Chile
Study Type
Interventional
Intervention
Behavioral
Sponsored by
Universidad de Los Lagos
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Morbid Obesity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

Inclusion Criteria:

  • Older than 18 and younger and ≤65 years of age.
  • With risk factors to Metabolic syndrome
  • With obesity and morbid obesity condition
  • Medical authorization by a physician.

Exclusion Criteria:

  • Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person).
  • Exercise-related dyspnoea or respiratory alterations.
  • Chronic heart disease with any worsening in the last month.
  • Adherence rate of less than 80% of the total interventions.

Sites / Locations

  • Cristian ALvarez

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Active comparator

Experimental group with morbid obesity

Arm Description

Control group with obesity under Resistant Training

Experimental group with morbid obesity under Resistant Training

Outcomes

Primary Outcome Measures

Fasting glucose
Component of the Metabolic Syndrome
High density lipoprotein
Component of the Metabolic Syndrome
Systolic blood pressure and diastolic blood pressure
Component of the Metabolic Syndrome
Waist circumference
Component of the Metabolic Syndrome
Triglycerides
Component of the Metabolic Syndrome

Secondary Outcome Measures

Body mass index
Anthropometric
Body mass
Anthropometric
Total cholesterol
Measured by plasma sample
Low density lipoprotein
Measured by plasma sample
Six minutes walking test
Endurance performance
One maximum repetition of biceps curl
Strength Performance
Handgrip muscle strength
Muscle strength

Full Information

First Posted
April 8, 2019
Last Updated
April 16, 2019
Sponsor
Universidad de Los Lagos
Collaborators
Universidad de La Frontera
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1. Study Identification

Unique Protocol Identification Number
NCT03921853
Brief Title
Resistance Training in Patients With Morbid Obesity
Acronym
ExinMO
Official Title
Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
Study Type
Interventional

2. Study Status

Record Verification Date
April 2019
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
April 4, 2018 (Actual)
Study Completion Date
April 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Universidad de Los Lagos
Collaborators
Universidad de La Frontera

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The researchers will conduct a study for avoiding the metabolic syndrome in morbid obese patients. Thus, the aim of the present will be determine the effects of a resistance training programme (RT) in preventing or attenuating metabolic syndrome (MetS) in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of improvements in MetS markers and other co-variables considered.
Detailed Description
The prevalence of metabolic syndrome (MetS) and cardiovascular disease is expected to rise along with the global obesity epidemic. MetS is a cluster of clinical risk factors, including abdominal (visceral) obesity, hypertension, elevated serum triglycerides, low serum high-density lipoprotein (HDL) and hyperglycaemia.The MetS for example, significantly decreases the life expectancy of individuals with morbid obesity and increases the disease burden and economic costs associated with healthcare. In this sense, more recently, there was reported that body mass index (BMI) and fat distribution showed higher associations with inflammation, fat indices, and more prevalence of MetS in morbidly obese subjects, claiming for an early prevention of the MetS in the morbid obese state. Exercise training has proven to be effective in inducing a clinically significant weight loss and reducing cardiovascular risk. Exercise have reported to be associated with increased muscle mass, decreased body fat, and improved metabolic profile (i.e., improved glucose control and lipid levels). In addition, supervised RT improved muscle strength and functional capacity in patients with obesity undergoing bariatric surgery. However, although RT has been widely studied in obesity, there is little information in the morbid obesity. On the other hand, there is poor knowledge similarly, about the interindividual variability to exercise training in terms of responders and non-responders (NR). Thus, considering the poor knowledge about the MetS prevention in morbid obese patients, as well as the little information about Responders and Non-Responders for improving MetS outcomes, the aim of this study will be determine the effects of a RT program on cardio-metabolic outcomes of MetS in patients with morbid obesity. A second aim will be report the prevalence of non-responders in terms of the effects of resistance training on MetS markers and other health-related variables.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morbid Obesity, Obesity, Physical Activity, Metabolic Syndrome, Risk Factor, Cardiovascular

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
Masking
Investigator
Masking Description
According with the availability and the feasibility of the enrolment's requirements, patients will be allocated to a control group with obesity, and another with morbid obesity.
Allocation
Non-Randomized
Enrollment
39 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active comparator
Arm Type
Active Comparator
Arm Description
Control group with obesity under Resistant Training
Arm Title
Experimental group with morbid obesity
Arm Type
Experimental
Arm Description
Experimental group with morbid obesity under Resistant Training
Intervention Type
Other
Intervention Name(s)
Behavioral
Other Intervention Name(s)
Resistant training intervention
Intervention Description
The 20-week RT program will consist of three sessions per week, each lasting for 1 hour that will be applied to both control obese (CG) and morbid obese (MO) group. All sessions will start with 15 minutes warm-up with continuous walking and joint mobility and flexibility exercises, 5 minutes of cool down and stretching, in order for preventing injuries. Sessions will include 4 to 8 RT exercises targeting different muscle groups; 1. forearm, 2. knee flexors and 3. extensors, 3. trunk, 4. chest, 5. shoulder elevators, 6. horizontal shoulder flexors and 7. extensors, and 8. plantar flexors. The exercises for each muscle group will be performed in 3 sets of as many repetitions (continuous concentric/eccentric voluntary contraction) possible in 1 minute followed by 2.0 minutes of passive recovery. Before the RT program, each participant will be measure using the subjective modified Borg scale (1-10 points), in order of identifying the muscle failure into 1 minute of exercise.
Primary Outcome Measure Information:
Title
Fasting glucose
Description
Component of the Metabolic Syndrome
Time Frame
Change from Baseline Fasting glucose at 20-weeks of Resistant Training
Title
High density lipoprotein
Description
Component of the Metabolic Syndrome
Time Frame
Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Title
Systolic blood pressure and diastolic blood pressure
Description
Component of the Metabolic Syndrome
Time Frame
from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Title
Waist circumference
Description
Component of the Metabolic Syndrome
Time Frame
Change from Baseline Waist circumference at 20-weeks of Resistant Training
Title
Triglycerides
Description
Component of the Metabolic Syndrome
Time Frame
Change from Baseline Triglycerides at 20-weeks of Resistant Training
Secondary Outcome Measure Information:
Title
Body mass index
Description
Anthropometric
Time Frame
Change from Baseline Body mass index at 20-weeks of Resistant Training
Title
Body mass
Description
Anthropometric
Time Frame
Change from Baseline Body mass at 20-weeks of Resistant Training
Title
Total cholesterol
Description
Measured by plasma sample
Time Frame
Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Title
Low density lipoprotein
Description
Measured by plasma sample
Time Frame
Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Title
Six minutes walking test
Description
Endurance performance
Time Frame
Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
Title
One maximum repetition of biceps curl
Description
Strength Performance
Time Frame
Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Title
Handgrip muscle strength
Description
Muscle strength
Time Frame
Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Inclusion Criteria: Older than 18 and younger and ≤65 years of age. With risk factors to Metabolic syndrome With obesity and morbid obesity condition Medical authorization by a physician. Exclusion Criteria: Physical limitations (e.g., restricting injuries of the musculoskeletal system, or dependent of a third person). Exercise-related dyspnoea or respiratory alterations. Chronic heart disease with any worsening in the last month. Adherence rate of less than 80% of the total interventions.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cristian ALvarez, PhD
Organizational Affiliation
Universidad de Los Lagos
Official's Role
Study Director
Facility Information:
Facility Name
Cristian ALvarez
City
Osorno
State/Province
Llanquihue
ZIP/Postal Code
5290000
Country
Chile

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The participants information will be available by e-mail according with researchers requirements.
Citations:
PubMed Identifier
31383503
Citation
Delgado-Floody P, Alvarez C, Lusa Cadore E, Flores-Opazo M, Caamano-Navarrete F, Izquierdo M. Preventing metabolic syndrome in morbid obesity with resistance training: Reporting interindividual variability. Nutr Metab Cardiovasc Dis. 2019 Dec;29(12):1368-1381. doi: 10.1016/j.numecd.2019.07.002. Epub 2019 Jul 12.
Results Reference
derived

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Resistance Training in Patients With Morbid Obesity

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