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Background There is increasing evidence of weight regain in patients after bariatric surgery (BS), generally occurring from 12 to 24 months postoperatively. Postoperative exercise has been suggested to ad long-term weight maintenance and to improve physical function in BS patients. However, there are a limited number of intervention studies investigating the possible benefits of exercise in this population. The aim of the current report is to provide a comprehensive CERT (Consensus on Exercise Reporting Template)-based description of the rationale and details of the exercise programme implemented in the EFIBAR Study ( Ejercicio FÍsico tras cirugía BARiátrica ), a randomised controlled trial investigating the effects of a 16-week supervised concurrent (aerobic and strength) exercise intervention program on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, physical activity and quality of life (secondary outcomes) in patients with severe/morbid obesity following bariatric surgery. Methods A total of 80 BS patients [60–80% expected women, aged 18 to 60 years, body mass index (BMI) ≥ 40 kg/m 2 or ≥ 35 kg/m 2 with comorbid conditions)] will be enrolled in the EFIBAR Randomized Control Trial (RCT). Participants allocated in the exercise group ( n = 40) will undertake a 16-week supervised concurrent (strength and aerobic) exercise programme (three sessions/week, 60 min/session), starting 7 to 14 days after surgery. The rationale of the exercise programme will be described following the CERT criteria detailing the 16 key items. The study has been reviewed and approved by the Ethics Committee of the Torrecárdenas University Hospital (Almería, Spain) (ref. N° 76/2016). Discussion The present study details the exercise programme of the EFIBAR RCT, which may serve: 1) exercise professionals who would like to implement an evidence-based exercise programme for BS patients, and 2) as an example of the application of the CERT criteria. Trial registration The trial was prospectively registered at Clinicaltrials.gov NCT03497546 on April 13, 2018. Electronic supplementary material The online version of this article (10.1186/s12893-019-0566-9) contains supplementary material, which is available to authorized users.
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 (3 sessions/week, 60 min/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 serum markers of chronic inflammation and insulin resistance (i.e., C-reactive protein, interleukin 6, tumor necrosis factor-alpha, leptin, glomerular sedimentation rate, glucose, insulin and the HOMA-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. Trial registration number: ISRCTN registry (ISRCTN27697878).
Background Previous studies have investigated weight loss caused by exercise following bariatric surgery. However, in most cases, the training program is poorly reported; the exercise type, volume, and intensity are briefly mentioned; and the sample size, selection criteria, and follow-up time vary greatly across studies. Purpose The EFIBAR study aims to investigate over 1 year the effects of a 16-week supervised exercise program, initiated immediately after bariatric surgery, on weight loss (primary outcome), body composition, cardiometabolic risk, physical fitness, and quality of life in patients with severe/extreme obesity. Material and Methods The EFIBAR study is a parallel-group, superiority, randomized controlled trial (RCT), comprising 80 surgery patients. Half of the participants, randomly selected, perform a 16-week supervised exercise program, including both strength and aerobic training, starting immediately after the surgery (7–14 days). For each participant, all primary and secondary outcomes are measured at three different time points: (i) before the surgery, (ii) after the intervention (≈4 months), and (iii) 1 year after the surgery. Conclusion The EFIBAR study will provide new insights into the multidimensional benefits of exercise in adults with severe/extreme obesity following bariatric surgery. Trial Registration EFIBAR randomized controlled trial was prospectively registered at Clinicaltrials.gov (NCT03497546) on April 13, 2018. Graphical abstract
Background and objectives: Several anthropometric and body composition parameters have been linked to arterial stiffness (AS) as a biomarker of cardiovascular disease. However, little is known about which of these closely related factors is more strongly associated with AS. The aim of the present study was to analyze the relationship of different anthropometric and body composition parameters with AS in middle-aged adults. Materials and Methods: This cross-sectional study included 186 middle-aged participants (85 women, 101 men; age = 42.8 ± 12.6 years) evaluated as part of the Healthy UAL study, a population study conducted at the University of Almería with the main purpose of analyzing the etiology and risk factors associated with cardio-metabolic diseases. Anthropometric measures included neck, waist, and hip circumferences, as well as the waist-to-height ratio (WHtr). Bioimpedance-derived parameters included fat-free mass index (FFMI), fat mass index (FMI), and percent of body fat (%BF). AS was measured by pulse wave velocity (PWV). The relationships of interest were examined through stepwise regression analyses in which age and sex were also introduced as potential confounders. Results: Neck circumference (in the anthropometric model; R 2: 0.889; β: age = 0.855, neck = 0.204) and FFMI (in the bio-impedance model; R2: 0.891; β: age = 0.906, FFMI = 0.199) emerged as significant cross-sectional predictors of AS. When all parameters were included together (both anthropometry and bio-impedance), both neck circumference and FFMI appeared again as being significantly associated with AS (R2: 0.894; β: age = 0.882, FFMI = 0.126, neck = 0.093). Conclusion: It was concluded that FFMI and neck circumference are correlated with AS regardless of potential confounders and other anthropometric and bioimpedance-derived parameters in middle-aged adults.
This study aimed to examine the association of relative handgrip strength (rHGS) with cardiometabolic disease risk factors in women with systemic lupus erythematosus (SLE). Methods: Seventy-seven women with SLE (mean age 43.2, SD 13.8) and clinical stability during the previous six months were included. Handgrip strength was assessed with a digital dynamometer and rHGS was defined as absolute handgrip strength (aHGS) divided by body mass index (BMI). We measured blood pressure, markers of lipid and glucose metabolism, inflammation (high sensitivity C-reactive protein [hs-CRP]), arterial stiffness (pulse wave velocity [PWV]), and renal function. A clustered cardiometabolic risk index (z-score) was computed. Results: Pearson′s bivariate correlations revealed that higher rHGS was associated with lower systolic blood pressure (SBP), triglycerides, hs-CRP, PWV, and lower clustered cardiometabolic risk (rrange = from −0.43 to −0.23; all p < 0.05). Multivariable linear regression analyses adjusted for age, disease activity (SLEDAI), and accrual damage (SDI) confirmed these results (all p < 0.05) except for triglycerides. Conclusions: The findings suggest that higher rHGS is significantly associated with lower cardiometabolic risk in women with SLE.
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