Effects of Exercise Training in Bariatric Patients

Effects of Exercise in Bariatric Patients: a Randomized Controlled Trial

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.

Study Overview

• Status: Unknown
• Conditions: Obesity
• Intervention / Treatment: Other: Exercise training

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Brazil
  • Sao Paulo, Brazil, 05508-030
    • Recruiting
    • University of Sao Paulo
    • Contact: Igor Murai, master; Phone Number: 551130918783; Email: gualano@usp.br

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
insulin sensitivity as assessed by surrogates of insulin sensitivity		6 months
body composition as assessed by densitometry (DEXA)	bone mass, lean mass and fat mass	6 months
profile of cytokines		6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
physical activity level as assessed by accelerometry		6 months
quality of life as assessed by questionnaires (composite)		6 months
muscle function as assessed by a battery of tests	timed-stands test, timed-up-ang-go test, maximal strength tests	6 months
risk of cardiovascular events as assessed by questionnaires (composite)		6 months
aerobic conditioning as assessed by a cardiopulmonary test.		6 months
depression and anxiety as assessed by questionnaires (composite)		6 months

Collaborators and Investigators

• Sponsor: University of Sao Paulo

Publications and helpful links

General Publications

• Gil S, Kirwan JP, Murai IH, Dantas WS, Merege-Filho CAA, Ghosh S, Shinjo SK, Pereira RMR, Teodoro WR, Felau SM, Benatti FB, de Sa-Pinto AL, Lima F, de Cleva R, Santo MA, Gualano B, Roschel H. A randomized clinical trial on the effects of exercise on muscle remodelling following bariatric surgery. J Cachexia Sarcopenia Muscle. 2021 Dec;12(6):1440-1455. doi: 10.1002/jcsm.12815. Epub 2021 Oct 19.
• Dantas WS, Roschel H, Murai IH, Gil S, Davuluri G, Axelrod CL, Ghosh S, Newman SS, Zhang H, Shinjo SK, das Neves W, Merege-Filho C, Teodoro WR, Capelozzi VL, Pereira RM, Benatti FB, de Sa-Pinto AL, de Cleva R, Santo MA, Kirwan JP, Gualano B. Exercise-Induced Increases in Insulin Sensitivity After Bariatric Surgery Are Mediated By Muscle Extracellular Matrix Remodeling. Diabetes. 2020 Aug;69(8):1675-1691. doi: 10.2337/db19-1180. Epub 2020 May 14. Erratum In: Diabetes. 2021 Jun;70(6):1415.
• Murai IH, Roschel H, Dantas WS, Gil S, Merege-Filho C, de Cleva R, de Sa-Pinto AL, Lima F, Santo MA, Benatti FB, Kirwan JP, Pereira RM, Gualano B. Exercise Mitigates Bone Loss in Women With Severe Obesity After Roux-en-Y Gastric Bypass: A Randomized Controlled Trial. J Clin Endocrinol Metab. 2019 Oct 1;104(10):4639-4650. doi: 10.1210/jc.2019-00074.

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: March 31, 2015
• First Submitted That Met QC Criteria: May 7, 2015
• First Posted (Estimate): May 12, 2015

Study Record Updates

• Last Update Posted (Estimate): May 12, 2015
• Last Update Submitted That Met QC Criteria: May 7, 2015
• Last Verified: May 1, 2015

More Information

Terms related to this study

• Other Study ID Numbers: Exercise & Bariatric