Introduction: Sedentary behavior (SB) and insufficient physical activity (PA) interact to worsen physical fitness (PF), obesity-related complications and diseases (ORCD), and all-cause mortality in women with obesity. Replacing SB with low-intensity PA may improve PF and ameliorate ORCD, with potential lasting effects after bariatric surgery (BS). However, strong evidence on how PF influences BS outcomes and whether preoperative PA interventions can improve postoperative outcomes is lacking. The BARIMOV study aims to evaluate the effects of a structured sedentary behavior reduction program (SBRPro) on PF, investigate whether PF improvements influence BS outcomes, and explore potential mechanistic pathways by characterizing molecular adaptations in peripheral blood, skeletal muscle, and visceral adipose tissue (VAT).
Methods: BARIMOV is a prospective cohort study with five assessment time points. Adult women (≥18 years) with BMI 30-45 kg/m² scheduled for BS will be recruited (n = 72). At T0, participants will undergo a baseline assessment of PF - body composition, muscle strength, cardiorespiratory fitness - PA patterns, and ORCD screening. Participants will be instructed in the SBRPro and asked to maintain weekly PA diaries throughout the pre- and post-operative periods. At T1, adherence to SBRPro will be evaluated via diary review and PF reassessment, to enable participants' allocation into two adherence-based groups. At T2, during surgery, skeletal muscle and VAT biopsies will be collected for proteomic analysis to compare molecular adaptations of adherent and non-adherent groups. At T3 and T4, primary outcomes, including weight loss, body composition, ORCD, and quality of life (QoL), will be evaluated at 3±1 and 12±1 months postoperatively, respectively. Blood multiomics profiling will be performed at T0, T1, and T3 to explore dynamic changes in systemic metabolic pathways over time.
Conclusion: This study will determine whether PF improvement, achieved through structured SB reduction and PA engagement, is associated with better BS outcomes. By integrating clinical and molecular endpoints, the study will provide mechanistic insights into the pathways by which PF enhances BS outcomes and inform physical activity intervention strategies.
Adult women (≥ 18 years);
BMI of 30-45 kg/m2;
Scheduled for primary vertical sleeve gastrectomy or Roux-en-Y gastric bypass;
Capacity to provide informed consent, adequate proficiency in the national language;
Previous bariatric surgery or gastric surgical procedure;
Physical incapacity or medical contraindications precluding physical fitness testing or participation (active cardiac disease, uncontrolled hypertension, severe joint disease);
Pregnancy or breastfeeding;
Inability to provide informed consent or comply with study procedures;
Parallel
Sedentary behavior reduction program on physical fitness.
BehavioralThe BARIMOV protocol incorporates this evidence through a structured, online sedentary behavior reduction program (SBRPro) that emphasizes substituting sedentary behavior with physical activity throughout the day.
Percentage of total weight loss (%TWL)
Primary clinical outcome evaluating the percentage of total weight loss, measuring weight in kilograms before and after surgery.
Obesity-related complications and diseases (ORCD)
Pre- and post-operative status comparison through in-person clinical evaluations and routine laboratory analyses, including physical examination findings and longitudinal changes in pharmacological treatment requirements. ORCD will be assessed as a composite outcome including the presence of the following conditions, defined using a standardized criterion: Type 2 diabetes mellitus: HbA1c≥6.5% or use of glucose-lowering medication; Hypertension: systolic BP≥140 mmHg, diastolic BP≥90 mmHg, or antihypertensive treatment; Dyslipidemia: LDL-C, HDL-C, or triglycerides outside guideline thresholds or lipid-lowering therapy; Obstructive sleep apnea: confirmed by polysomnography \[AHI≥5 events/hour\]; Gastroesophageal reflux disease (GERD): heartburn and/or acid regurgitation occurring≥2 times per week or current use of proton pump inhibitors (PPIs) for reflux symptoms with prior physician diagnosis of GERD; Metabolic syndrome: defined according to NCEP ATP ΙΙΙ criteria.
Changes in health-related quality of life (QoL)
Primary clinical outcome assessed by using the SF-12 (12-item Short Form Health Survey), a validated questionnaire.
Body composition
Body composition \[fat mass (in kilograms and percentage), lean mass (in kilograms and percentage), muscle mass (in kilograms and percentage)\], measured via bioimpedance analysis (InBody 970 model, Biospace, Korea), will be combined to report the complete assessment of body composition.
Muscle strength
Muscle strength (Kgf) will be assessed using handgrip (Jamar+, Lafayette Instrument Company, USA) and knee isometric strength tests (GripWise, Wisify Tech Solutions, Lda., Portugal). The handgrip strength evaluation method follows the Southampton protocol. Participants perform three trials in each hand (alternating sides), and the maximal grip score will be used. Assessment of isometric knee extensor strength will be performed with participants seated. The test involves three maximal voluntary isometric contractions. Participants will be instructed to hold the side of the plinth for stabilization. Constant verbal encouragement will be provided throughout the testing. A submaximal practice trial is performed for each leg to ensure the participant understands the required contraction. Three trials will be recorded for each knee, and the maximal strength value will be used.
Cardiorespiratory fitness (CRF)
The estimated CRF (ml/min/kg) will be evaluated using the 2-minute step test (2MST). Briefly, the 2MST will be performed using a single, portable step that is 15 cm high. Participants are instructed to go up and down the step as many times as possible for two minutes (free cadence). The evaluator is responsible for counting up-and-down step cycles (UDS). The test will be performed according to the recommendations of the American Thoracic Society.
Identification of proteomic differences in skeletal muscle and visceral adipose tissue associated with adherence at the time of surgery
Tissue fragments will be immediately processed and preserved at -80 ºC for downstream proteomic analysis. Label-free quantitative proteomics, using the GeLC MS/MS approach, will be performed to identify differential protein expression patterns between adherence groups.
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Hospital de Sao Sebastiao
Lead sponsor
Universidade Lusófona - Centro Universitário do Porto
Collaborator
Unidade Multidisciplinar de Investigação Biomédica, Universidade do Porto
Collaborator
COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal)
Collaborator
