Physical Exercise following bariatric surgery in women with Morbid obesity Study protocol clinical trial (SPIRIT compliant).
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2020
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Medicine
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Abstract
Background: Severe and morbid obesity are increasing globally, particularly in women. As BMI increases, the likelihood of
anovulation is higher. The primary aim of the EMOVAR clinical trial is to examine, over the short (16 weeks) and medium (12 months)
term, the effects of a supervised physical exercise program (focused primarily on aerobic and resistance training) on ovarian function
in women with severe/morbid obesity who have undergone bariatric surgery. Secondary objectives are to examine the effects of the
intervention on chronic inflammation, insulin resistance, arterial stiffness, physical fitness, and health-related quality of life.
Methods: This is a randomized controlled trial in which ∼40 female bariatric surgery patients, aged between 18 and 45 years old, will
be included. Participants assigned to the experimental group will perform a total of 48 sessions of supervised concurrent (strength and
aerobic) training (3sessions/week, 60min/session) spread over 16 weeks. Patients assigned to the control group will receive lifestyle
recommendations. Outcomes will be assessed at baseline, week 16 (i.e., after the exercise intervention) and 12 months after surgery.
The primary outcome is ovarian function using the Sex-Hormone Binding Globuline, measured in serum. Secondary outcomes are
serum levels of anti-mullerian hormone, TSH, T4, FSH, LH, estradiol, prolactine, and free androgen index, as well as oocyte count, the
diameters of both ovaries, endometrial thickness, and uterine arterial pulsatility index (obtained from a transvaginal ultrasound), the
duration of menstrual bleeding and menstrual cycle duration (obtained by personal interview) and hirsutism (Ferriman Gallwey Scale).
Other secondary outcomes include serummarkers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6,
tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and theHOMA-IR), arterial stiffness, systolic, diastolic
and mean blood pressure, body composition, and total weight loss. Physical fitness (including cardiorespiratory fitness, muscular
strength, and flexibility), health-related quality of life (SF-36 v2) and sexual function (Female Sexual Function Index) will also be measured.
Discussion: This study will provide, for the first time, relevant information on the effects of exercise training on ovarian function and
underlying mechanisms in severe/morbid obese women following bariatric surgery.