Resistance Training in Patients With Morbid Obesity (ExinMO)

Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence

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.

Study Overview

• Status: Completed
• Conditions: Obesity; Physical Activity; Metabolic Syndrome; Risk Factor, Cardiovascular; Morbid Obesity
• Intervention / Treatment: Other: Behavioral

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Chile
  • Llanquihue
    • Osorno, Llanquihue, Chile, 5290000
      • Cristian ALvarez

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Active comparator; Control group with obesity under Resistant Training	Other: Behavioral; 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.; Other Names: Resistant training intervention
Experimental: Experimental group with morbid obesity; Experimental group with morbid obesity under Resistant Training	Other: Behavioral; 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.; Other Names: Resistant training intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fasting glucose	Component of the Metabolic Syndrome	Change from Baseline Fasting glucose at 20-weeks of Resistant Training
High density lipoprotein	Component of the Metabolic Syndrome	Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Systolic blood pressure and diastolic blood pressure	Component of the Metabolic Syndrome	from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training
Waist circumference	Component of the Metabolic Syndrome	Change from Baseline Waist circumference at 20-weeks of Resistant Training
Triglycerides	Component of the Metabolic Syndrome	Change from Baseline Triglycerides at 20-weeks of Resistant Training

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Body mass index	Anthropometric	Change from Baseline Body mass index at 20-weeks of Resistant Training
Body mass	Anthropometric	Change from Baseline Body mass at 20-weeks of Resistant Training
Total cholesterol	Measured by plasma sample	Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Low density lipoprotein	Measured by plasma sample	Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Six minutes walking test	Endurance performance	Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
One maximum repetition of biceps curl	Strength Performance	Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Handgrip muscle strength	Muscle strength	Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training

Collaborators and Investigators

• Sponsor: Universidad de Los Lagos
• Collaborators: Universidad de La Frontera
• Investigators: Study Director: Cristian ALvarez, PhD, Universidad de Los Lagos

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2018
• Primary Completion (Actual): April 4, 2018
• Study Completion (Actual): April 30, 2018

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 16, 2019
• First Posted (Actual): April 19, 2019

Study Record Updates

• Last Update Posted (Actual): April 19, 2019
• Last Update Submitted That Met QC Criteria: April 16, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Glucose Metabolism Disorders; Metabolic Diseases; Disease; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Syndrome; Obesity; Metabolic Syndrome; Obesity, Morbid
• Other Study ID Numbers: RP08042019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: The participants information will be available by e-mail according with researchers requirements.

Drug and device information, study documents

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