Effects of Exercise Training in Bariatric Patients

Obesity Clinical Trial

Official title:

Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02441361
• Other study ID #: Exercise & Bariatric
• Status: Recruiting
• Phase: N/A
• First received: March 31, 2015
• Last updated: May 7, 2015
• Start date: March 2015
• Est. completion date: December 2017

Study information

• Verified date: May 2015
• Source: University of Sao Paulo
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: National Committee of Ethics in Research
• Study type: Interventional

Clinical Trial Summary

Bariatric surgery may attenuate insulin resistance and low-grade inflammation in obese subjects. This trial aims to test whether exercise training can add to the benefits of bariatric surgery on insulin sensitivity and inflammation. In addition, this study aims to investigate whether exercise training can counteract bone loss induced by bariatric surgery.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• body mass index = 35 kg/m2

• not engaged in physical activity programs

• without any physical limitation that could preclude exercise participation

Exclusion Criteria:

• body mass index < 35 kg/m2

• regular participation in physical activities programs

• cancer or any other disease that could limit participation in exercise

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Other:
• Exercise training
Exercise training will comprise aerobic and strength exercises

Locations

Country	Name	City	State
Brazil	University of Sao Paulo	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	insulin sensitivity as assessed by surrogates of insulin sensitivity		6 months	No
Primary	body composition as assessed by densitometry (DEXA)	bone mass, lean mass and fat mass	6 months	No
Primary	profile of cytokines		6 months	No
Secondary	physical activity level as assessed by accelerometry		6 months	No
Secondary	quality of life as assessed by questionnaires (composite)		6 months	No
Secondary	muscle function as assessed by a battery of tests	timed-stands test, timed-up-ang-go test, maximal strength tests	6 months	No
Secondary	risk of cardiovascular events as assessed by questionnaires (composite)		6 months	Yes
Secondary	aerobic conditioning as assessed by a cardiopulmonary test.		6 months	No
Secondary	depression and anxiety as assessed by questionnaires (composite)		6 months	No