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

Bariatric Surgery Candidate Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03159312
• Other study ID #: 23/01/2017 UGR
• Status: Completed
• Phase: N/A
• Start date: March 30, 2017
• Est. completion date: March 18, 2018

Study information

• Verified date: October 2019
• Source: Universidad de Granada
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: March 18, 2018
• Est. primary completion date: March 15, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate

Intervention

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.

Locations

Country	Name	City	State
Spain	Universidad de Granada	Granada

Sponsors (1)

Lead Sponsor	Collaborator
Universidad de Granada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Blood sugar level	Hemoglucotest, for measuring peripheral blood glucose	1 year
Secondary	Quality of sleep	Pittsburgh Sleep Quality Questionnaire	1 year
Secondary	Anthropometric measures	Rosscraft anthropometry kit containing Campbell 20 (Campbell 10) and Bioelectrical impedance.	1 year
Secondary	Level of physical ability	Borg scale	1 year
Secondary	Level of physical ability	6-minute walk test	1 year
Secondary	Perception of health	Assessment pre-operated patients bariatric surgery	1 year
Secondary	Cardiovascular function	With dynamometer	1 year
Secondary	Cardiovascular function	Tensiometers cable	1 year
Secondary	Cardiovascular function	Cells of load.	1 year
Secondary	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