Resistance Training in Patients With Morbid Obesity

Obesity Clinical Trial

— ExinMO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03921853
• Other study ID #: RP08042019
• Status: Completed
• Phase: N/A
• Start date: January 1, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: April 2019
• Source: Universidad de Los Lagos
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 30, 2018
• Est. primary completion date: April 4, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

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.

Locations

Country	Name	City	State
Chile	Cristian ALvarez	Osorno	Llanquihue

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Los Lagos	Universidad de la Frontera

Country where clinical trial is conducted

Chile, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Fasting glucose	Component of the Metabolic Syndrome	Change from Baseline Fasting glucose at 20-weeks of Resistant Training
Primary	High density lipoprotein	Component of the Metabolic Syndrome	Change from Baseline High density lipoprotein at 20-weeks of Resistant Training
Primary	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
Primary	Waist circumference	Component of the Metabolic Syndrome	Change from Baseline Waist circumference at 20-weeks of Resistant Training
Primary	Triglycerides	Component of the Metabolic Syndrome	Change from Baseline Triglycerides at 20-weeks of Resistant Training
Secondary	Body mass index	Anthropometric	Change from Baseline Body mass index at 20-weeks of Resistant Training
Secondary	Body mass	Anthropometric	Change from Baseline Body mass at 20-weeks of Resistant Training
Secondary	Total cholesterol	Measured by plasma sample	Change from Baseline Total cholesterol at 20-weeks of Resistant Training
Secondary	Low density lipoprotein	Measured by plasma sample	Change from Baseline Low density lipoprotein at 20-weeks of Resistant Training
Secondary	Six minutes walking test	Endurance performance	Change from Baseline Six minutes walking test density lipoprotein at 20-weeks of Resistant Training
Secondary	One maximum repetition of biceps curl	Strength Performance	Change from Baseline One maximum repetition of biceps curl at 20-weeks of Resistant Training
Secondary	Handgrip muscle strength	Muscle strength	Change from Baseline Handgrip muscle strength at 20-weeks of Resistant Training