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Effects of Exercise Training in Bariatric Patients

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ClinicalTrials.gov Identifier: NCT02441361
Recruitment Status : Unknown
Verified May 2015 by Bruno Gualano, University of Sao Paulo.
Recruitment status was:  Recruiting
First Posted : May 12, 2015
Last Update Posted : May 12, 2015
Sponsor:
Information provided by (Responsible Party):
Bruno Gualano, University of Sao Paulo

Brief 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.

Condition or disease Intervention/treatment Phase
Obesity Other: Exercise training Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial
Study Start Date : March 2015
Estimated Primary Completion Date : December 2017
Estimated Study Completion Date : December 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
No Intervention: control
Subjects will undergo bariatric surgery and no exercise training will be prescribed.
Experimental: exercise training
Subjects will undergo bariatric surgery and exercise training will be prescribed.
Other: Exercise training
Exercise training will comprise aerobic and strength exercises




Primary Outcome Measures :
  1. insulin sensitivity as assessed by surrogates of insulin sensitivity [ Time Frame: 6 months ]
  2. body composition as assessed by densitometry (DEXA) [ Time Frame: 6 months ]
    bone mass, lean mass and fat mass

  3. profile of cytokines [ Time Frame: 6 months ]

Secondary Outcome Measures :
  1. physical activity level as assessed by accelerometry [ Time Frame: 6 months ]
  2. quality of life as assessed by questionnaires (composite) [ Time Frame: 6 months ]
  3. muscle function as assessed by a battery of tests [ Time Frame: 6 months ]
    timed-stands test, timed-up-ang-go test, maximal strength tests

  4. risk of cardiovascular events as assessed by questionnaires (composite) [ Time Frame: 6 months ]
  5. aerobic conditioning as assessed by a cardiopulmonary test. [ Time Frame: 6 months ]
  6. depression and anxiety as assessed by questionnaires (composite) [ Time Frame: 6 months ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02441361


Locations
Brazil
University of Sao Paulo Recruiting
Sao Paulo, Brazil, 05508-030
Contact: Igor Murai, master    551130918783    gualano@usp.br   
Principal Investigator: Bruno Gualano, Professor         
Sponsors and Collaborators
University of Sao Paulo

Responsible Party: Bruno Gualano, Professor, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02441361     History of Changes
Other Study ID Numbers: Exercise & Bariatric
First Posted: May 12, 2015    Key Record Dates
Last Update Posted: May 12, 2015
Last Verified: May 2015