Resistance Training in Patients With Morbid Obesity

NCT03921853 | Completed DMC

• 1 other identifier: RP08042019
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

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.

Conditions

Morbid Obesity; Obesity; Physical Activity; Metabolic Syndrome; Risk Factor, Cardiovascular

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Body mass index

  Change from Baseline Body mass index at 20-weeks of Resistant Training

• Body mass

  Change from Baseline Body mass at 20-weeks of Resistant Training

• Total cholesterol

  Change from Baseline Total cholesterol at 20-weeks of Resistant Training

• Low density lipoprotein

  Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training

• Six minutes walking test

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

Study Arms (2)

Active comparator

ACTIVE COMPARATOR

Control group with obesity under Resistant Training

Other: Behavioral

Experimental group with morbid obesity

EXPERIMENTAL

Experimental group with morbid obesity under Resistant Training

Other: Behavioral

Interventions

Behavioral OTHER

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.

Also known as: Resistant training intervention

Active comparator; Experimental group with morbid obesity

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidad de Los Lagos: lead
• Universidad de La Frontera: collaborator

Study Sites (1)

Cristian ALvarez

Osorno, Llanquihue, 5290000, Chile

Location

Related Publications (1)

• 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.

  PMID: 31383503 DERIVED

MeSH Terms

Conditions

Obesity, Morbid; Obesity; Motor Activity; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases

Study Officials

• Cristian ALvarez, PhD

  Universidad de Los Lagos

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: We will compare a control group with obesity with another experimental group with morbid obesity in the metabolic syndrome parameters.

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 19, 2019
• Study Start: January 1, 2018
• Primary Completion: April 4, 2018
• Study Completion: April 30, 2018
• Last Updated: April 19, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share

Locations

CL (1)