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| Name | Class |
|---|---|
| Universidade Lusófona - Centro Universitário do Porto | UNKNOWN |
| Unidade Multidisciplinar de Investigação Biomédica, Universidade do Porto | UNKNOWN |
| COFAC Cooperativa de Formacao e Animacao Cultural CRL (Portugal) |
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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.
Phase 1: Enrollment and Multidisciplinary Education (T0) All participants will attend a group educational session (40 minutes) delivered by a multidisciplinary team (bariatric surgeon, exercise physiologist, dietitian) addressing: 1) overall education about the BS clinical process and surgery procedures, risks, advantages and disadvantages; 2) a comprehensive education on SB harms and health risks, and benefits of PA across the pre- and post-operative period; 3) practical strategies for reducing sedentary time (e.g., breaking up prolonged sitting or interrupting extended bouts); 4) PA safety, proper exercise execution, PA intensity management and progression strategies; 5) nutritional education for preoperative fitness and postoperative recovery; and 6) distribution of written materials (flyers and booklets) summarizing key take home contents delivered at the session.
Phase 2: Structured Preoperative Sedentary Behavior Reduction Program (T0 to T1) Participants will be asked to engage in the SBRPro, which includes aerobic and strength activities, in compliance with current PA guidelines. Flexibility to adapt the PA and exercise modality, duration, and intensity based on individual preferences, physical capacity, and available resources (home-based, gym-based, online platforms, or combined approaches) will be provided.
Phase 3: Structured Postoperative Sedentary Behavior Reduction Program (T2 to T4) Participants will be asked to resume SBRPro activities within the first week post-BS, adjusting the program for postoperative individual restrictions. A progressive increase in daily PA will be encouraged. For resistance exercises, participants will be advised to avoid heavy loading of incision/staple lines and to progress from light to moderate resistance as tolerated. Given the postoperative vulnerability, remote counseling will be provided as needed to enhance safety. The same weekly PA diary-based monitoring will be requested.
Physical Activity Monitoring and Adherence Assessment SBRPro adherence will be assessed through a structured weekly PA diary using a simple online form. The form will collect self-reported data on average daily sedentary time (minutes per day), total time spent in light, moderate, and vigorous physical activity (minutes per week), and the number of days per week engaged in resistance training. The form will also include a subsection addressing PA satisfaction/enjoyment (5-point Likert scale: 1, nothing fun; 2, little fun; 3, indifferent; 4, fun; 5, very fun), and any barriers or adverse events encountered. This weekly assessment will take place from baseline (the moment of enrolment in the study) until up to 12 months after surgery. For primary analyses, adherence subgroups, determined from the weekly PA diary, will be classified as having either an active or a sedentary lifestyle according to the most recent World Health Organization criteria. Individuals will be classified as physically active if they accumulate at least 150 minutes of moderate-intensity physical activity per week, and as sedentary if they do not meet this threshold. Participants with a sedentary lifestyle will serve as the de facto comparison group. This will enable evaluation of whether differential engagement with the SBRPro is associated with distinct clinical and functional outcomes.
During BS (T2), biopsies of abdominal skeletal muscle (transversus abdominis) and visceral adipose tissue (VAT) will be obtained under direct surgical visualization. Tissue fragments will be immediately processed and preserved at -80ºC 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. Functional enrichment and pathway analyses will be conducted to characterize biological processes associated with preoperative SB reduction and PA engagement.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adherent group | Experimental | Participants will be instructed in the sedentary behavior reduction program (SBRPro) and asked to maintain weekly physical activity diaries throughout the pre- and post-operative periods. |
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| Non-adherent group | No Intervention | Non-adherence to the sedentary behavior reduction program. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sedentary behavior reduction program on physical fitness. | Behavioral | The 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of total weight loss (%TWL) | Primary clinical outcome evaluating the percentage of total weight loss, measuring weight in kilograms before and after surgery. | Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months 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. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
| 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. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Unidade Local de Saúde Entre Douro e Vouga | Contact | +351 256 379 700 | geral@ulsedv.min-saude.pt |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidade Local de Saúde de Entre Douro e Vouga | Recruiting | Santa Maria da Feira | 4520-211 | Portugal |
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| 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. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
| 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. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
| 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. | Intra-operative: T2 |
| Longitudinal blood metabolomic adaptations | Plasma will be processed and stored at -80 ºC for metabolomic profiling. Circulating metabolomic profiling will be performed using proton nuclear magnetic resonance (1H-NMR) spectroscopy to evaluate longitudinal systemic metabolic adaptations across time points. | Preoperative assessments: T0 (6±3 months before surgery), and T1 (2 weeks±3 days before surgery). Postoperative reassessment: T3 (3±1 months after surgery) and T4 (12±2 months after surgery). |
| ID | Term |
|---|---|
| D009765 | Obesity |
| D057185 | Sedentary Behavior |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D001836 | Body Weight Changes |
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