[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05097885":3,"trial-entities:NCT05097885":104,"trial-summary:NCT05097885":108},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":21,"primary_purpose":22,"phases":23,"enrollment_info":25,"interventions":28,"primary_outcomes":34,"secondary_outcomes":54,"sex":55,"minimum_age":56,"maximum_age":57,"healthy_volunteers":58,"eligibility_criteria":59,"std_ages":70,"locations":73,"central_contacts":93,"overall_officials":101,"references":102,"see_also_links":103},"NCT05097885","1818010","Health Benefits of Whole-body Vibration","Pilot Investigation on the Health Benefits of Sub Acute (12 Week) Whole-body Vibration Training","RECRUITING","2028-01-01","2025-01","2025-01-28","2022-02-28","Augusta University","OTHER",false,"The overall goals of this pilot investigation are to determine 1) the feasibility of conducting home based WBV studies, and 2) to determine if sub-acute home based WBV can improve a) exercise capacity, b) conduit- and micro- vascular function, and c) skeletal muscle function.","Cardiovascular disease (CVD) is the leading cause of death in the world and many comorbid conditions (i.e. diabetes, obesity) can affect overall CVD risk. There is increasing interest into the role that skeletal muscle health plays in mediating CVD risk, particularly in metabolic disease states (ie. obesity and diabetes). Whole body vibration (WBV) has emerged as an exercise mimetic that may be more tolerable than traditional modes of exercise, such as treadmill walking\u002Frunning or cycling. Similar to traditional exercise modalities, WBV can elicit beneficial metabolic effects. In fact, a single bout of WBV increases circulating concentrations of IL-6, which correspond with the normalization of glucose and insulin in obese individuals. The proposed pilot investigation will provide the foundation to begin understanding the molecular and physiological mechanisms of how sub-acute WBV can improve overall CVD risk. We hypothesize that home based WBV will decrease CVD risk by improving skeletal muscle and vascular function via a decrease in systemic inflammation.",[19],"Whole-body Vibration",[],"INTERVENTIONAL","TREATMENT",[24],"NA",{"count":26,"type":27},40,"ESTIMATED",[29],{"type":14,"name":30,"description":31,"armGroupLabels":32},"Sub Acute Whole Body Vibration Training","Participants will be given a personal vibration plate to take home with them for training which will last for 12 weeks. For the first four weeks, participants will be asked to complete 10 minutes of WBV per day (1 minute on and up to 1 minute of rest), at least 3-4 days per week. At least 24 hours will be recommended in between sessions during weeks 1-4. Beginning at week 5, participants will be asked to increase WBV time to up to 14 minutes and\u002For reduce the duration of rest. Beginning at week 9, participants will be asked to increase WBV time to up to 20 minutes and\u002For reduce the duration of rest.",[33],"Sub Acute (12 week) Whole Body Training",[35,39,42,45,48,51],{"measure":36,"description":37,"timeFrame":38},"Change in VO2 Peak","change from baseline relative (mL\u002Fkg\u002Fmin) peak oxygen consumption (VO2) during maximal exercise test at 12 weeks","pre-treatment baseline and following 12 weeks sub-acute whole-body vibration",{"measure":40,"description":41,"timeFrame":38},"Change in Flow-Mediated Dilation (FMD)","change from baseline brachial artery flow mediated dilation at 12 weeks.",{"measure":43,"description":44,"timeFrame":38},"Change in Skeletal Muscle Mitochondrial Function","change from baseline skeletal muscle mitochondrial function at 12 weeks. Measured using Near Infrared Spectroscopy (NIRS). Values are an index of phosphocreatine recovery expressed as a rate constant (min-1)",{"measure":46,"description":47,"timeFrame":38},"Change in Pulse Wave Velocity (PWV)","Change from baseline PWV at 12 weeks. Measured by Shygmocor Xcel in m\u002Fs.",{"measure":49,"description":50,"timeFrame":38},"Change in Post Occlusive Reactive Hyperemia (PORH)","Change from baseline PORH at 12 weeks. Measured by Laser Speckle Contrast Imager (Moor FLPI).",{"measure":52,"description":53,"timeFrame":38},"Change in IL-6","change from baseline concentrations of Interleukin 6 (IL-6) obtained via blood draw at 12 weeks.",[],"ALL","18 Years",null,true,{"inclusion":60,"exclusion":63,"raw_text":69},[61,62],"Men and women (\\> 18 yrs old)","All races",[64,65,66,67,68],"\\\u003C18 years old","Clinical diagnosis of hepatic, cardiovascular, or renal disease","Diabetic complications (i.e. macrovascular, microvascular, or autonomic)","Pregnancy","Direct vasoactive medications (i.e. nitrates)","Inclusion Criteria:\n\n* Men and women (\\> 18 yrs old)\n* All races\n\nExclusion Criteria:\n\n* \\\u003C18 years old\n* Clinical diagnosis of hepatic, cardiovascular, or renal disease\n* Diabetic complications (i.e. macrovascular, microvascular, or autonomic)\n* Pregnancy\n* Direct vasoactive medications (i.e. nitrates)",[71,72],"ADULT","OLDER_ADULT",[74],{"facility":75,"status":8,"city":76,"state":77,"zip":78,"country":79,"contacts":80,"geoPoint":90},"Augusta University\u002FGeorgia Prevention Institute\u002F Laboratory of Integrative and Exercise Physiology","Augusta","Georgia","30912","United States",[81,86],{"name":82,"role":83,"phone":84,"email":85},"Ryan Harris, PhD, CEP","CONTACT","706-721-5998","ryharris@augusta.edu",{"name":87,"role":83,"phone":88,"email":89},"Casey Derella, BS","706-721-5483","cderella@augusta.edu",{"lat":91,"lon":92},33.47097,-81.97484,[94,98],{"name":95,"role":83,"phone":96,"email":97},"Jacob Looney, MS","7067215483","jlooney@augusta.edu",{"name":99,"role":83,"phone":100,"email":85},"Ryan Harris, PhD","7067215998",[],[],[],{"nct_id":4,"conditions":105,"biomarkers":107},[106],"Healthy Volunteers",[],{"nct_id":4,"found":58,"summary":109,"prompt_version":118},{"design":110,"status":111,"heading":6,"summary":112,"follow_up":113,"word_count":114,"commitments":115,"compensation":116,"drugs_mentioned":117},"This is an interventional study planning to enroll 40 participants. It is not specified if it is randomized or blinded.","completed","This study is looking into the health benefits of Whole-body Vibration (WBV). Researchers want to see if using a personal vibration plate at home can improve your exercise ability, blood vessel function, and muscle function. You would use a vibration plate for 10 minutes a day, 3-4 days a week, for 12 weeks. The study aims to understand if WBV can help reduce the risk of heart disease, especially in people with conditions like diabetes or obesity. They will measure changes in your exercise capacity (VO2 Peak), blood vessel health (Flow-Mediated Dilation or FMD), and muscle function. The study is currently unclear on its recruitment status. You may be able to join if you are 18 years or older, but you cannot participate if you have certain heart, liver, or kidney diseases, diabetic complications, are pregnant, or take certain medications that affect blood vessels.","Participants will be followed for 12 weeks, with measurements taken at baseline and after the 12-week intervention.",144,"You would use a personal vibration plate at home for 12 weeks. For the first four weeks, you'd do 10 minutes of WBV per day (1 minute on, up to 1 minute rest), at least 3-4 days per week. Measurements will be taken at the start and after 12 weeks.","Not stated in the trial record.",[],"v2"]