ExinMO: Resistance Training in Patients With Morbid Obesity

Sponsor
Universidad de Los Lagos (Other)
Overall Status
Completed
CT.gov ID
NCT03921853
Collaborator
Universidad de La Frontera (Other)
39
1
2
3.9
10

Study Details

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
  • Other: Behavioral
N/A

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
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.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 :
Jan 1, 2018
Actual Primary Completion Date :
Apr 4, 2018
Actual Study Completion Date :
Apr 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 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
  • Outcome Measures

    Primary Outcome Measures

    1. Fasting glucose [Change from Baseline Fasting glucose at 20-weeks of Resistant Training]

      Component of the Metabolic Syndrome

    2. High density lipoprotein [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 [from Baseline Systolic blood pressure and diastolic blood after 20-weeks of Resistant Training]

      Component of the Metabolic Syndrome

    4. Waist circumference [Change from Baseline Waist circumference at 20-weeks of Resistant Training]

      Component of the Metabolic Syndrome

    5. Triglycerides [Change from Baseline Triglycerides at 20-weeks of Resistant Training]

      Component of the Metabolic Syndrome

    Secondary Outcome Measures

    1. Body mass index [Change from Baseline Body mass index at 20-weeks of Resistant Training]

      Anthropometric

    2. Body mass [Change from Baseline Body mass at 20-weeks of Resistant Training]

      Anthropometric

    3. Total cholesterol [Change from Baseline Total cholesterol at 20-weeks of Resistant Training]

      Measured by plasma sample

    4. Low density lipoprotein [Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training]

      Measured by plasma sample

    5. Six minutes walking test [Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training]

      Endurance performance

    6. One maximum repetition of biceps curl [Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training]

      Strength Performance

    7. Handgrip muscle strength [Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training]

      Muscle strength

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Site City State Country Postal Code
    1 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)

    More Information

    Publications

    None provided.
    Responsible Party:
    Universidad de Los Lagos
    ClinicalTrials.gov Identifier:
    NCT03921853
    Other Study ID Numbers:
    • RP08042019
    First Posted:
    Apr 19, 2019
    Last Update Posted:
    Apr 19, 2019
    Last Verified:
    Apr 1, 2019
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Apr 19, 2019