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Status unknownNCT02441361Updated May 12, 2015

Effects of Exercise Training in Bariatric Patients

An interventional study of Exercise training in Obesity, sponsored by University of Sao Paulo. Status unknown at 1 site in Brazil. Open to female participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-05-12.

Sponsored by University of Sao Paulo · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2015), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
Female
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Study 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.

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Conditions studied

  • Obesity
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In context

Lead sponsor

University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes

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

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
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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

Interventions

  • OtherExercise training

    Exercise training will comprise aerobic and strength exercises

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What researchers measure

Primary outcomes

  1. insulin sensitivity as assessed by surrogates of insulin sensitivity

    Time frame: 6 months

  2. body composition as assessed by densitometry (DEXA)

    bone mass, lean mass and fat mass

    Time frame: 6 months

  3. profile of cytokines

    Time frame: 6 months

Secondary outcomes

  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

    timed-stands test, timed-up-ang-go test, maximal strength tests

    Time frame: 6 months

  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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Study locations

1 of 1 sites recruiting
  • University of Sao Paulo
    Sao Paulo, 05508-030, Brazil
    • Igor Murai, master · Contact · gualano@usp.br · 551130918783
    • Bruno Gualano, Professor · Principal investigator
    Recruiting
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References and documents

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. PubMed 34666419 ↗
  • 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. doi: 10.2337/db21-er06b. PubMed 32409493 ↗
  • 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. PubMed 31322672 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 12, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02441361
Lead sponsor
University of Sao Paulo
Responsible party
Bruno Gualano (Professor, University of Sao Paulo) — Principal investigator
First posted
May 12, 2015
Start date
Mar 2015
Primary completion
Dec 2017 (estimated)
Completion
Dec 2017 (estimated)
Last update
May 12, 2015

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2015. You cannot join it, but the record below documents what was studied.

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