Effect Physical Exercise in Morbid Obesity

Morbid Obesity Clinical Trial

Official title:

Effect of Physical Exercise on Different Approaches to Treatment of Morbid Obesity

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02406976
• Other study ID #: 10-0328
• Status: Active, not recruiting
• Phase: N/A
• First received: March 30, 2015
• Last updated: March 10, 2017
• Start date: August 2010
• Est. completion date: November 2018

Study information

• Verified date: March 2017
• Source: Hospital de Clinicas de Porto Alegre
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This objective study to verify the effect of physical training with and without behavioral cognitive therapy, compared with controls, in functional capacity and cardio-metabolic profile in individuals with morbidly obese

Description:

This study is a Randomized Clinical Trial, with individuals with morbid obesity, and will be consists of 3 groups:

1. Group 1 (G1 EXERCISE): This group will participate in an physical exercise program twice a week in hospital.

2. Group 2 (G2 - LIFESTYLE AND EXERCISE): This groups will receive the same G1 intervention associated with a weekly group followed up with techniques of cognitive behavioral therapy with a psychologist

3. Group 3 (G3 - CONTROL): This group will keep medical appointments information and routine procedure in the hospital.

Will be included in study the individuals with morbid obesity who do not have contraindications to practice low-intensity exercise.

Exclusion criteria are contraindications to physical exercise, individuals with cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association), orthopedic problems, severe retinopathy, severe neuropathy, drug addicts and severe mental illness, metabolic or blood pressure decompensated.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 60
• Est. completion date: November 2018
• Est. primary completion date: November 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Individuals with morbid obesity

• Individuals do not have contraindications to practice low-intensity exercise.

Exclusion Criteria:

• Contraindications to physical exercise

• Cardiovascular disease with reduced functional capacity (class III and IV of the New York Heart Association)

• Orthopedic problems

• Severe retinopathy

• Severe neuropathy

• Drug addicts and severe mental illness

• High blood pressure or metabolic decompensation

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Other:
• G1 -Exercise
20 minutes of aerobic exercises of low intensity (2-4 on the Borg scale) in the rhythm of different songs that encourage their implementation. After these exercises will be performed five minutes of stretching exercises. Furthermore the similar treatment to G3.

Behavioral:
• G2- Exercise and Lifestyle
Exercise more techniques of cognitive behavioral therapy based on principles of learning, in order to promote and maintain new healthy behaviors and the reduction or elimination of undesirable conduct. Furthermore the similar treatment to G3.

Other:
• G3- Control
Routine treatment in outpatient of bariatric surgery. Consists of individual consultations and 05 (five) information meetings organized by the multidisciplinary team composed by the surgeon, endocrinologist, psychologist, psychiatrist, nutritionist, physical education teacher, pulmonologist, cardiologist and nurse. The G1 and G2 will also receive this intervention.

Locations

Country	Name	City	State
Brazil	Hospital de Clínicas de Porto Alegre	Porto Alegre	Rio Grande do Sul

Sponsors (1)

Lead Sponsor	Collaborator
Hospital de Clinicas de Porto Alegre

Country where clinical trial is conducted

Brazil, 

References & Publications (2)

Fonseca Jr SJ, et al. Exercício Físico e Obesidade Mórbida: Uma Revisão Sistemática. ABCD Arq Bras Cir Dig 2013;26(Suplemento 1):67-73

Marcon ER, Gus I, Neumann CR. [Impact of a minimum program of supervised exercises in the cardiometabolic risk in patients with morbid obesity]. Arq Bras Endocrinol Metabol. 2011 Jun;55(5):331-8. Portuguese. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Weight Loss		baseline and Four months
Secondary	Metabolic Parameters (composite)	Metabolic parameters will be evaluated using total cholesterol, HDL, triglycerides and glucose (Assessment at baseline and 4 months).	baseline and Four months
Secondary	Six minute walk test (6MWT)	Functional capacity will be evaluated using the six minute walk test (6MWT)	baseline and Four months