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Completed

NCT Number: NCT03159312

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.

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Key information

Conditions

Bariatric Surgery Candidate Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Universidad de Granada

Granada, 18071, Spain

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

Primary outcomes

  1. 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

  1. Blood sugar level

    Time frame: 1 year

    Hemoglucotest, for measuring peripheral blood glucose

  2. Quality of sleep

    Time frame: 1 year

    Pittsburgh Sleep Quality Questionnaire

  3. Anthropometric measures

    Time frame: 1 year

    Rosscraft anthropometry kit containing Campbell 20 (Campbell 10) and Bioelectrical impedance.

  4. Level of physical ability

    Time frame: 1 year

    Borg scale

  5. Level of physical ability

    Time frame: 1 year

    6-minute walk test

  6. Perception of health

    Time frame: 1 year

    Assessment pre-operated patients bariatric surgery

  7. Cardiovascular function

    Time frame: 1 year

    With dynamometer

  8. Cardiovascular function

    Time frame: 1 year

    Tensiometers cable

  9. Cardiovascular function

    Time frame: 1 year

    Cells of load.

  10. Strength

    Time frame: 1 year

    To analyze the strength and the dynamic resistance were used: free weights (dumbells and bars) exercise machines with constant, variable or isokinetic resistance

Sponsors and collaborators

Lead sponsor

Universidad de Granada

Other

Registry information

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
May 18, 2017
Registry last updated
Oct 28, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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