Resistance Training in Patients With Morbid Obesity (ExinMO)

• ClinicalTrials.gov Identifier: NCT03921853
• Recruitment Status: Completed
• First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Sponsor: Universidad de Los Lagos
• Collaborator: Universidad de la Frontera
• Information provided by (Responsible Party): Universidad de Los Lagos

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.

Condition or disease	Intervention/treatment	Phase
Morbid Obesity; Obesity; Physical Activity; Metabolic Syndrome; Risk Factor, Cardiovascular	Other: Behavioral	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 39 participants
• Allocation: Non-Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.
• Masking: Single (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.
• Primary Purpose: Prevention
• Official Title: Preventing Metabolic Syndrome in Patients With Morbid Obesity by Resistance Training: Reporting Non-responder Prevalence
• Actual Study Start Date: January 1, 2018
• Actual Primary Completion Date: April 4, 2018
• Actual Study Completion Date: April 30, 2018

Arms and Interventions

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 Name: 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 Name: Resistant training intervention

Outcome Measures

Primary Outcome Measures :

1. Fasting glucose [ Time Frame: Change from Baseline Fasting glucose at 20-weeks of Resistant Training ]
   Component of the Metabolic Syndrome
2. High density lipoprotein [ Time Frame: Change from Baseline High density lipoprotein at 20-weeks of Resistant Training ]
   Component of the Metabolic Syndrome
3. Systolic blood pressure and diastolic blood pressure [ Time Frame: from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training ]
   Component of the Metabolic Syndrome
4. Waist circumference [ Time Frame: Change from Baseline Waist circumference at 20-weeks of Resistant Training ]
   Component of the Metabolic Syndrome
5. Triglycerides [ Time Frame: Change from Baseline Triglycerides at 20-weeks of Resistant Training ]
   Component of the Metabolic Syndrome

Secondary Outcome Measures :

1. Body mass index [ Time Frame: Change from Baseline Body mass index at 20-weeks of Resistant Training ]
   Anthropometric
2. Body mass [ Time Frame: Change from Baseline Body mass at 20-weeks of Resistant Training ]
   Anthropometric
3. Total cholesterol [ Time Frame: Change from Baseline Total cholesterol at 20-weeks of Resistant Training ]
   Measured by plasma sample
4. Low density lipoprotein [ Time Frame: Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training ]
   Measured by plasma sample
5. Six minutes walking test [ Time Frame: Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training ]
   Endurance performance
6. One maximum repetition of biceps curl [ Time Frame: Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training ]
   Strength Performance
7. Handgrip muscle strength [ Time Frame: Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training ]
   Muscle strength

Eligibility Criteria

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

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.

Contacts and Locations

Locations

Chile

Cristian ALvarez

Osorno, Llanquihue, Chile, 5290000

Sponsors and Collaborators

Universidad de Los Lagos

Universidad de la Frontera

Investigators

• Study Director: Cristian ALvarez, PhD; Universidad de Los Lagos

  Study Documents (Full-Text)

Documents provided by Universidad de Los Lagos:

Study Protocol and Statistical Analysis Plan  [PDF] April 11, 2019

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Delgado-Floody P, Álvarez C, Lusa Cadore E, Flores-Opazo M, Caamaño-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.

• Responsible Party: Universidad de Los Lagos
• ClinicalTrials.gov Identifier: NCT03921853
• Other Study ID Numbers: RP08042019
• First Posted: April 19, 2019
• Last Update Posted: April 19, 2019
• Last Verified: April 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: The participants information will be available by e-mail according with researchers requirements.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Obesity; Metabolic Syndrome; Obesity, Morbid; Syndrome; Disease; Pathologic Processes; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases