[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07296991":3,"trial-entities:NCT07296991":90,"trial-summary:NCT07296991":94},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":6,"overall_status":7,"completion_date":8,"status_verified_date":9,"last_update_date":10,"start_date":11,"sponsor_name":12,"lead_sponsor_class":13,"has_dmc":14,"brief_summary":15,"detailed_description":16,"conditions":17,"keywords":20,"study_type":25,"primary_purpose":26,"phases":27,"enrollment_info":29,"interventions":32,"primary_outcomes":44,"secondary_outcomes":49,"sex":53,"minimum_age":54,"maximum_age":55,"healthy_volunteers":14,"eligibility_criteria":56,"std_ages":60,"locations":62,"central_contacts":81,"overall_officials":85,"references":88,"see_also_links":89},"NCT07296991","IRB-23-06-5927","VR Stimulation of Exercise Response in Sedentary Humans","RECRUITING","2028-08","2025-12","2025-12-23","2025-09-30","Wayne State University","OTHER",false,"Prolonged sedentary conditions contribute to declining health across human populations and cause significant secondary health consequences for many patients whose illnesses or injuries prevent them from exercising. The investigators have demonstrated that in a small animal fruit fly model, genetic stimulation of neurons that promote adrenergic signaling is sufficient to mimic the benefits of exercise training even in sedentary animals. The investigator's pilot work in humans has confirmed that humans respond to Virtual Reality (VR) stimuli that mimic exercise by increasing heart rate and altering heart rate variability in a way consistent with increased adrenergic activity.\n\nIn this study, the investigators will directly test for the first time whether repeated, controlled exposure to VR stimuli that induce adrenergic activity in sedentary humans can produce adaptive changes to protein expression and endurance performance like those produced by actual exercise in pre-diabetic participants with\u002Fwithout hypertension.",null,[18,19],"Prolonged Inactivity","Metabolic Syndrome",[21,22,23,24],"Exercise","metabolic syndrome","insulin resistance","virtual reality","INTERVENTIONAL","TREATMENT",[28],"NA",{"count":30,"type":31},48,"ESTIMATED",[33,39],{"type":34,"name":35,"description":35,"armGroupLabels":36},"BEHAVIORAL","20 minutes cycling exercise",[37,38],"EX-20 minutes sub max cycling exercise","VR+: 20 minutes sub max cycling exercise + virtual reality",{"type":34,"name":40,"description":41,"armGroupLabels":42},"Virtual Reality","20 minutes virtual cycling",[38,43],"VR-virtual reality exercise",[45],{"measure":46,"description":47,"timeFrame":48},"Blood Glucose, HbA1C","Pre-diabetic patients (Blood glucose 100-125 mg\u002FdL, AbA1C 5.7-6.4%) may see improvement in values post-intervention","10 weeks",[50],{"measure":51,"description":52,"timeFrame":48},"10 minute walk time","distance walked in 10 minutes is recorded pre- and post- intervention and may improve","ALL","25 Years","40 Years",{"inclusion":57,"exclusion":58,"raw_text":59},[],[],"Inclusion Criteria:\n\n1. Equal numbers male and female (32 each)\n2. Blood glucose HbA1C: 5.7-6.4% or 100-125 mg\u002FdL\n3. BP: systolic\\\u003C120 and diastolic\\\u003C80 mmHg, systolic 120-129 mmHg and diastolic \\\u003C80 mmHg, or systolic \\>130 mmHg and diastolic \\>80 mmHg\n\nExclusion Criteria:\n\n1. BMI\\>35kg\u002Fm2\n2. Currently involved in an exercise program or similar activity\n3. Taking medications that could affect results, including beta-blockers or SSRIs\n4. Demonstrate any form of discomfort with the VR experience through self-reported feelings of anxiety or nausea\n5. Alcohol consumption above a minimal level(\\\u003C2 oz\u002Fnight)\n6. BP: Systolic \\>160 mmHg and Diastolic \\>110 mmHg",[61],"ADULT",[63],{"facility":12,"status":7,"city":64,"state":65,"zip":66,"country":67,"contacts":68,"geoPoint":78},"Detroit","Michigan","48201","United States",[69,74],{"name":70,"role":71,"phone":72,"email":73},"Alyson Sujkowski, PhD","CONTACT","419-461-4317","asujkows@med.wayne.edu",{"name":75,"role":71,"phone":76,"email":77},"Robert J Wessells, PhD","734-476-4325","rwessell@med.wayne.edu",{"lat":79,"lon":80},42.33143,-83.04575,[82,83],{"name":70,"role":71,"phone":72,"email":73},{"name":75,"role":71,"phone":84},"7344764325",[86],{"name":75,"affiliation":12,"role":87},"PRINCIPAL_INVESTIGATOR",[],[],{"nct_id":4,"conditions":91,"biomarkers":93},[92,19],"Insulin Resistance",[],{"nct_id":4,"found":95,"summary":96,"prompt_version":105},true,{"design":97,"status":98,"heading":6,"summary":99,"follow_up":100,"word_count":101,"commitments":102,"compensation":103,"drugs_mentioned":104},"This interventional study plans to enroll 48 participants to compare two different behavioral interventions.","completed","This study is exploring whether virtual reality (VR) can mimic the benefits of exercise for people who are mostly inactive. Researchers are comparing 20 minutes of cycling exercise to 20 minutes of virtual cycling. The goal is to see if VR can help improve health markers like blood glucose and HbA1C (a measure of average blood sugar over time) after 10 weeks. You may be able to join if you are between 25 and 40 years old, have specific blood glucose or HbA1C levels, and are not currently exercising regularly. The study aims to enroll 48 participants.","Your blood glucose and HbA1C will be measured at 10 weeks.",97,"Not specified in the trial record.","Not stated in the trial record.",[40],"v2"]