Influence of a Moderate Physical Exercise Program in Health of Patients Underwent Bariatric Surgery in Talca City, Chile

NCT03159312 | Completed DMC

• 1 other identifier: 23/01/2017 UGR
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Obesity is a multifactorial disorder resulting from multivariate etiopathogenic factors. The current lifestyle, causes a gradual increase in weight both in the adult population and in the child population. Among their treatments is bariatric surgery. About which there is little evidence in the literature regarding the health condition developed by patients operated on the same. Objective: To know the influence of a moderate exercise program on health status in patients operated on with bariatric surgery. Methodology: A controlled clinical trial, the population will consist of 32 women and 11 men. Coming from the consultations of bariatric surgery of the Clinic of the Maule - Talca. In the period between March 2017 and March 2018. It will be selected following a non-probabilistic sampling and for convenience. Results Analysis: The variables used in this study will be: cardiovascular function, respiratory function, strength, health perception, anthropometric measures and functional capacity to perform exercises. The Shapiro-Wilk normality test will be performed to determine the distribution of the data to be analyzed. The t-student test or its nonparametric counterpart will be applied to compare two variables. To compare three or more variables, the ANOVA or Kruskal-Wallis test will be used depending on the results of the normality test.

Conditions

Bariatric Surgery Candidate

Keywords

obesity,bariatric surgery,physical activity

Outcome Measures

Primary Outcomes (1)

• Quality of life prior to bariatric surgery and subsequent

  Nottingham Scale: It is a generic instrument for measuring the physical, psychological and social suffering associated with medical, social and emotional problems of the extent to which such suffering affects the lives of individuals, and ICIQ-SF urinary incontinence questionnaire

  1 year

Secondary Outcomes (10)

• Blood sugar level

  1 year

• Quality of sleep

  1 year

• Anthropometric measures

  1 year

• Level of physical ability

  1 year

• Level of physical ability

  1 year

Study Arms (2)

Assigned Interventions

EXPERIMENTAL

20 individuals undergoing bariatric surgery and post surgery normal indications with moderate exercise program

Behavioral: Physical activity based on a moderate exercise program

Control group

NO INTERVENTION

Control group: 23 individuals undergoing bariatric surgery and post surgery normal indications without exercise program

Interventions

Physical activity based on a moderate exercise program BEHAVIORAL

Physical exercise program begins with a 2-week adaptation stage, climbs onto the treadmill (HP Cosmos®). The programming of the tape will be done initially with an intensity of 40% of its FCdRes obtained from the formula of Karvonen after performing the 6-minute walk test, you will have to maintain that intensity for 15 min, the patient is evaluated with the Borg scale and oxygen saturation permanently.After two weeks of adaptation, the HRdRes becomes to be calculated, 59% of said frequency will be modified until the exercise program is completed.The training is 30 minutes in the tradmill machine.The work of muscle strengthening of biceps, triceps, deltoids and pectorals, will be progressive in intensity and number of repetitions, determined by the evaluation of 1 Rmax. The start of work with weights is 40% of the Rmax, it will be modified monthly from 40% to 75%. Cycloergometer training (Monark ®) is without load for 15 minutes.

Assigned Interventions

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Signed informed consent.
• Do not suffer any absolute contraindication.
• Patients who will undergo bariatric surgery and who reside in the city of Talca.
• Age between 18 - 60 years.
• With weight \<180 kilograms.

You may not qualify if:

• Medical indication for basic pathologies.
• Post-operative complications.
• Acute angina-like pain during the 6-minute gait test.
• Absence of 2 or more trainings in a row.
• Pregnancy within the first 6 months post-surgery.

Sponsors & Collaborators

• Universidad de Granada: lead

Study Sites (1)

Universidad de Granada

Granada, 18071, Spain

Location

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 3, 2017
• First Posted: May 18, 2017
• Study Start: March 30, 2017
• Primary Completion: March 15, 2018
• Study Completion: March 18, 2018
• Last Updated: October 28, 2019

Record last verified: 2019-10

Locations

ES (1)