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

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.

Study Overview

• Status: Completed
• Conditions: Bariatric Surgery Candidate
• Intervention / Treatment: Behavioral: Physical activity based on a moderate exercise program

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Spain
  • Granada, Spain, 18071
    • Universidad de Granada

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Assigned Interventions; 20 individuals undergoing bariatric surgery and post surgery normal indications with moderate exercise program	Behavioral: Physical activity based on a moderate exercise program; 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.
No Intervention: Control group; Control group: 23 individuals undergoing bariatric surgery and post surgery normal indications without exercise program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood sugar level	Hemoglucotest, for measuring peripheral blood glucose	1 year
Quality of sleep	Pittsburgh Sleep Quality Questionnaire	1 year
Anthropometric measures	Rosscraft anthropometry kit containing Campbell 20 (Campbell 10) and Bioelectrical impedance.	1 year
Level of physical ability	Borg scale	1 year
Level of physical ability	6-minute walk test	1 year
Perception of health	Assessment pre-operated patients bariatric surgery	1 year
Cardiovascular function	With dynamometer	1 year
Cardiovascular function	Tensiometers cable	1 year
Cardiovascular function	Cells of load.	1 year
Strength	To analyze the strength and the dynamic resistance were used: free weights (dumbells and bars) exercise machines with constant, variable or isokinetic resistance	1 year

Collaborators and Investigators

• Sponsor: Universidad de Granada

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2017
• Primary Completion (Actual): March 15, 2018
• Study Completion (Actual): March 18, 2018

Study Registration Dates

• First Submitted: April 3, 2017
• First Submitted That Met QC Criteria: May 17, 2017
• First Posted (Actual): May 18, 2017

Study Record Updates

• Last Update Posted (Actual): October 28, 2019
• Last Update Submitted That Met QC Criteria: October 24, 2019
• Last Verified: October 1, 2019

More Information

Terms related to this study

• Keywords: obesity,bariatric surgery,physical activity
• Other Study ID Numbers: 23/01/2017 UGR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No