protocolSection identificationModule nctId: NCT06274606, orgStudyIdInfo id: HSR230106, briefTitle: Exercise Training Study Before Bariatric Surgery, acronym: BaSE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-03-15, studyFirstPostDateStruct date: 2024-02-23, lastUpdatePostDateStruct date: 2024-02-23, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to figure out if 8 weeks of walking exercise before bariatric surgery improves risk factors for diabetes and other markers of health. This is important as it may help reduce complications after surgery, improve health markers and increase physical activity levels after surgery (which is an important marker of maintaining bariatric weight loss). The main question that this study is trying to answer is whether walking improves a risk factor for type 2 diabetes called insulin sensitivity (how well your body is able to use glucose).Adults planning to have bariatric surgery will be recruited from the Charlottesville VA area. Before they have their surgery, participants will be randomly assigned (like flipping a coin) to a group that participates in 8 weeks of walking on a treadmill (2-3 times a week) or a group that does their normal care before bariatric surgery.Researchers will compare the effects of walking before bariatric surgery on:* Insulin sensitivity (diabetes risk factor)* Health of blood vessels* Rate of complications after surgery* Weight* Body Fat* Fitness level, conditionsModule conditions: Bariatric Surgery Candidate, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: In accordance with a parallel study design, 30 pre-bariatric-surgery patients will be randomized in a 1:1 ratio to either undergo 8-weeks of pre-operative standard of care or 8-weeks of pre-operative standard of care plus moderate exercise prior to undergoing bariatric-surgery. Randomization scheme: The randomization will be generated utilizing a permuted block randomization scheme in which 5 blocks of 6 treatment assignments (3 per treatment) will be generated via a computer algorithm. The 6 treatment assignments of each block will be listed in random sequential order and the treatment assignments will be assigned according to the random sequential order. The randomization will be generated by our biostatistician., primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, maskingDescription: Randomization will be completely random and will only be known by biostatistician and study coordinator in department but not on study to retain true randomization unaffected by study team., enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Exercise Group, outcomesModule primaryOutcomes measure: Insulin sensitivity, secondaryOutcomes measure: Surgical outcomes - readmission within 30 days of surgery, secondaryOutcomes measure: Surgical outcomes - IV treatment as an outpatient, secondaryOutcomes measure: Surgical outcomes - emergency department visits, secondaryOutcomes measure: Surgical outcomes - time of surgery, secondaryOutcomes measure: Surgical outcomes - length of stay after surgery completion, secondaryOutcomes measure: Flow-mediated dilation (FMD), secondaryOutcomes measure: Pulse-wave analysis (PWA), secondaryOutcomes measure: Pulse-wave velocity (PWV), secondaryOutcomes measure: Body fat, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Bone mineral density, secondaryOutcomes measure: Visceral adiposity, secondaryOutcomes measure: Weight, secondaryOutcomes measure: Blood Lipids, secondaryOutcomes measure: Plasma glucose, secondaryOutcomes measure: Plasma insulin, secondaryOutcomes measure: Hemoglobin A1c, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Quality of life (SF-36), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Virginia, city: Charlottesville, state: Virginia, zip: 22902, country: United States, contacts name: Damon L Swift, PhD, role: CONTACT, phone: 434-924-1436, email: dls3s@virginia.edu, contacts name: Emily E Grammer, MS, role: CONTACT, phone: 8508968401, email: erk9nk@virginia.edu, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False