[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT07223437":3,"trial-entities:NCT07223437":106,"trial-summary:NCT07223437":110},{"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":14,"conditions":16,"keywords":18,"study_type":19,"primary_purpose":20,"phases":21,"enrollment_info":23,"interventions":26,"primary_outcomes":43,"secondary_outcomes":57,"sex":73,"minimum_age":74,"maximum_age":14,"healthy_volunteers":75,"eligibility_criteria":76,"std_ages":80,"locations":83,"central_contacts":97,"overall_officials":103,"references":104,"see_also_links":105},"NCT07223437","5460","REVASC-PAD: REstricted VASCular Exercise for Peripheral Arterial Disease - A Feasibility Study at University of Tennessee Medical Center","RECRUITING","2027-04-27","2025-10","2026-04-29","2026-04-27","University of Tennessee Graduate School of Medicine","OTHER",null,"The purpose of this study is to evaluate the effects of Blood Flow Restriction (BFR) training on walking function, health-related quality of life, and safety among adults with Peripheral Arterial Disease (PAD).\n\nThe main aims of the study are:\n\n1. Evaluate change in walking function among patients with PAD undergoing BFR training. The investigators will assess change in Six-Minute Walk Test (6MWT) distance from baseline to post-intervention and 3-month follow-up to compare functional improvements between the BFR group and the two control groups\n2. Assess changes in health-related quality of life among patients with PAD undergoing BFR training. The investigators will use the EuroQol 5-Dimension 5-Level (EQ-5D-5L) scale to evaluate quality-of-life changes from baseline to post-intervention and 3-month follow-up across all study arms\n3. Evaluate the safety and feasibility of a supervised BFR training program for patients with PAD. The investigators will compare adverse event (AE) and serious adverse event (SAE) rates across study arms, while also monitoring sessional ratings of perceived exertion (RPE), dyspnea, and claudication pain as indicators of symptom response and exercise tolerance. Feasibility will be assessed through enrollment success, intervention adherence, and retention rates across groups",[17],"Peripheral Arterial Disease",[],"INTERVENTIONAL","TREATMENT",[22],"NA",{"count":24,"type":25},81,"ESTIMATED",[27,33,38],{"type":28,"name":29,"description":30,"armGroupLabels":31},"BEHAVIORAL","Blood Flow Restriction Cuff System","All BFR resistance sessions will include two standardized lower-extremity exercises: seated calf raises and standing calf raises. Each session will follow this protocol:\n\n1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions\n2. 30 seconds rest between sets, with the cuff remaining inflated\n3. Load set at 20-35% of 1RM\n4. Cuff deflated immediately after the fourth set or after 6 continuous minutes of inflation, whichever comes first",[32],"Blood Flow Restriction (BFR) Training",{"type":28,"name":34,"description":35,"armGroupLabels":36},"Low-load Resistance Training","Two resistance exercises (seated and standing calf raises) using the same repetition structure\n\n1. 1 set of 30 repetitions, followed by 3 sets of 15 repetitions\n2. Load set at 20-35% of 1RM\n3. 30 seconds rest between sets\n4. No BFR cuffs will be used",[37],"Low-Load Traditional Resistance Training (LL-RT)",{"type":28,"name":39,"description":40,"armGroupLabels":41},"High-load Resistance Training","Each session includes:\n\n1. 3 sets of 8-12 repetitions\n2. Load set at 60-70% of 1RM\n3. Rest periods of 60-90 seconds between sets\n4. No BFR cuffs will be used",[42],"High-Load Traditional Resistance Training (HL-RT)",[44,48,51,54],{"measure":45,"description":46,"timeFrame":47},"Walking Function","Change in walking distance measured by the Six-Minute Walk Test (6MWT) from baseline to end of intervention and 3-month follow-up visit.","Baseline (Visit 1), post-intervention (8 to 12 weeks), and 3-month follow-up (3MF)",{"measure":49,"description":50,"timeFrame":47},"Quality of Life (QoL) (1)","Change in health-related quality of life as assessed by EuroQol 5-Dimension 5-Level (EQ-5D-5L) from baseline to post-intervention and 3-month follow-up",{"measure":52,"description":53,"timeFrame":47},"Quality of Life (QoL) (2)","Change in depressive symptoms as assessed by Patient Health Questionnaire-9 (PHQ-9) from baseline to post-intervention and 3-month follow-up",{"measure":55,"description":56,"timeFrame":47},"Quality of Life (QoL) (3)","Change in self-reported walking function and symptom burden assessed by using REVASC-PAD Walking Questionnaire from baseline to post-intervention and 3-month follow-up",[58,62,66,70],{"measure":59,"description":60,"timeFrame":61},"Claudication Onset Time (COT) during 6MWT","Time to onset of claudication symptoms during 6MWT at baseline, post-intervention, and 3-month follow-up","Baseline, post-intervention (8 to 12 weeks), and 3 months post-intervention",{"measure":63,"description":64,"timeFrame":65},"Ratings of Perceived Exertion (RPE), Dyspnea, and Claudication Pain","Session-based self-reported symptom ratings collected at each supervised exercise session from Visit 2 to end of intervention (approximately 8 to 12 weeks). These ratings assess exercise tolerance and symptom burden during blood flow restriction training.","Multiple assessments from Visit 2 through end of intervention (approximately 8 to 12 weeks)",{"measure":67,"description":68,"timeFrame":69},"Adverse Event (AE) and Serious Adverse Event (SAE) Rates","Number and rate of adverse events and serious adverse events occurring during the study period.","Baseline to 3-month follow-up",{"measure":71,"description":72,"timeFrame":69},"Enrollment, Retention, and Adherence Rates","Rates of successful enrollment, participant retention at post-intervention and 3-month follow-up, and adherence to prescribed exercise sessions","ALL","18 Years",false,{"inclusion":77,"exclusion":78,"raw_text":79},[],[],"Inclusion Criteria:\n\n1. 18 years of age or older\n2. Diagnosed peripheral arterial disease with stable claudication (symptomatic presentation unchanged for 6 months)\n3. Ankle-brachial index (ABI) between 0.4 and 0.9.\n4. Eligible referral to cardiovascular or pulmonary rehabilitation\n5. Prior revascularization permitted if symptoms are stable and other criteria are met\n\nExclusion Criteria:\n\n1. Recent change in resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 weeks), or another acute cardiac event\n2. Unstable angina\n3. Uncontrolled cardiac arrhythmias\n4. Symptomatic severe aortic stenosis or other significant valvular disease\n5. Decompensated symptomatic heart failure\n6. Acute pulmonary embolism or infarction\n7. Acute noncardiac disorder likely to interfere with or be worsened by exercise (e.g., infection, thyrotoxicosis)\n8. Acute myocarditis or pericarditis\n9. Acute thrombophlebitis\n10. Physical disability precluding safe or adequate exercise performance\n11. Significant electrolyte abnormalities\n12. Clinically significant tachyarrhythmias or bradyarrhythmias\n13. High-degree atrioventricular block\n14. Atrial fibrillation with uncontrolled ventricular response\n15. Hypertrophic obstructive cardiomyopathy with resting left ventricular outflow gradient of \\>25 mmHg\n16. Known active aortic dissection\n17. Severe resting arterial hypertension (SBP\\>200mmHg or DBP \\>110 mmHg)\n18. Mental impairment preventing cooperation with study procedures\n19. Current pregnancy\n20. Moderate to severe peripheral neuropathy\n21. Open wounds or compromised skin near BFR cuff site\n22. Active DVT or thromboembolic event within the past year",[81,82],"ADULT","OLDER_ADULT",[84],{"facility":85,"status":7,"city":86,"state":87,"zip":88,"country":89,"contacts":90,"geoPoint":94},"University of Tennessee Medical Center","Knoxville","Tennessee","37920","United States",[91],{"name":92,"role":93},"Morgan Randall, MD","PRINCIPAL_INVESTIGATOR",{"lat":95,"lon":96},35.96064,-83.92074,[98],{"name":99,"role":100,"phone":101,"email":102},"Tiffany Johnson, Study Coordinator","CONTACT","+1865-305-4682","thjohnson@utmck.edu",[],[],[],{"nct_id":4,"conditions":107,"biomarkers":109},[108],"Peripheral Artery Disease",[],{"nct_id":4,"found":111,"summary":112,"prompt_version":122},true,{"design":113,"status":114,"heading":115,"summary":116,"follow_up":117,"word_count":118,"commitments":119,"compensation":120,"drugs_mentioned":121},"This is an interventional study with a planned enrollment of 81 participants. It compares three different exercise interventions.","completed","REVASC-PAD: Exercise for Peripheral Arterial Disease","This study, REVASC-PAD, is looking at how different types of exercise affect people with Peripheral Arterial Disease (PAD). PAD is a condition where narrowed arteries reduce blood flow to your limbs. We are testing a method called Blood Flow Restriction (BFR) training, which uses a cuff during exercise, against two other exercise methods: low-load resistance training and high-load resistance training. We want to see if BFR training can improve your walking ability and quality of life, and if it is safe. We are looking for 81 adults aged 18 or older who have been diagnosed with PAD and have stable leg pain (claudication). Your ankle-brachial index (ABI), a measure of blood flow, should be between 0.4 and 0.9. The study aims to see how your walking function and quality of life change over time with these exercises.","Participants will be followed for 3 months after the intervention period.",137,"You would participate in exercise sessions, which include seated and standing calf raises. Your walking function and quality of life will be measured at the start, after 8-12 weeks of intervention, and again 3 months later.","Not stated in the trial record.",[34,39],"v2"]