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Clinical Trials/NCT03159312
NCT03159312CompletedNot Applicable

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

Universidad de Granada1 site in 1 country40 target enrollmentStarted: March 30, 2017Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Quality of life prior to bariatric surgery and subsequent

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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.

Arms & Interventions

Control group

No Intervention

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

Assigned Interventions

Experimental

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

Intervention: Physical activity based on a moderate exercise program (Behavioral)

Outcomes

Primary Outcomes

Quality of life prior to bariatric surgery and subsequent

Time Frame: 1 year

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

Secondary Outcomes

  • Level of physical ability(1 year)
  • Cardiovascular function(1 year)
  • Perception of health(1 year)
  • Anthropometric measures(1 year)
  • Strength(1 year)
  • Blood sugar level(1 year)
  • Quality of sleep(1 year)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

María José Aguilar Cordero

Professor

Universidad de Granada

Study Sites (1)

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