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Resistance Training in Patients With Morbid Obesity (ExinMO)

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

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.


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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

Resource links provided by the National Library of Medicine


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




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



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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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03921853


Locations
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Chile
Cristian ALvarez
Osorno, Llanquihue, Chile, 5290000
Sponsors and Collaborators
Universidad de Los Lagos
Universidad de la Frontera
Investigators
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Study Director: Cristian ALvarez, PhD Universidad de Los Lagos
  Study Documents (Full-Text)

Documents provided by Universidad de Los Lagos:

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Responsible Party: Universidad de Los Lagos
ClinicalTrials.gov Identifier: NCT03921853     History of Changes
Other Study ID Numbers: RP08042019
First Posted: April 19, 2019    Key Record Dates
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.

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

Additional relevant MeSH terms:
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Syndrome
Obesity
Metabolic Syndrome
Obesity, Morbid
Disease
Pathologic Processes
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases