[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100568489":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":24,"centralContacts":28,"locations":37,"responsibleParty":74,"collaborators":76,"id":80,"slug":81,"hasResults":82,"nctId":83,"briefTitle":84,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":82,"sex":87,"minAge":88,"maxAge":18,"enrollmentInfo":89,"targetDuration":18,"studyType":92,"phases":93,"briefSummary":95,"conditions":96,"keywords":100,"overallStatus":39,"whyStopped":18,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Royal United Hospitals Bath NHS Foundation Trust","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"MICROFIT + Usual Care","EXPERIMENTAL","MICROFIT intervention will be delivered in addition to Usual Care arm clinical review and advice. MICROFIT is a 24-week long personalized one-on-one exercise and dietary education intervention, along with home exercise guided by personal trainers. Exercise intervention includes High Intensity Interval Training (HIIT) and dietary advice focuses on incorporation of a Mediterranean-type diet.",[13],"Other: MICROFIT - personalised high intensity interval training exercise rehabilitation and dietary advice",{"label":15,"type":16,"description":17,"interventionNames":18},"Usual Care","NO_INTERVENTION","All patients will be reviewed clinically by a cardiologist. They will address cardiovascular risk factors and prescribe any therapies as indicated by current medical guidelines, for example statin or ACE inhibitors. The Cardiologist will also provide routine, verbal one-off lifestyle advice in line with NICE guidance, recommending 150 minutes of moderate exercise per week, encouraging a healthy, balanced diet, weight loss, reducing alcohol consumption and smoking cessation where necessary.",null,[20],{"type":6,"name":21,"description":22,"armGroupLabels":23,"otherNames":18},"MICROFIT - personalised high intensity interval training exercise rehabilitation and dietary advice","MICROFIT is a 24-week long personalized one-on-one exercise and dietary education intervention, along with home exercise guided by personal trainers. Exercise intervention includes High Intensity Interval Training (HIIT) and dietary advice focuses on incorporation of a Mediterranean-type diet.\n\nPhase 1 - Induction (8 weeks) Exercise: Twice-weekly 1-hour personal trainer (PT) supervised exercise sessions. 45 minute homework exercise session once a week.\n\nDiet: 1-hour educational session with a dietician, followed by two 30-minute follow up sessions.\n\nPhase 2 - Consolidation (10 weeks) Exercise: Once weekly 1 hour PT sessions, two 45 minute homework sessions once a week.\n\nDiet: 30-minute sessions every 5 weeks.\n\nPhase 3 - Maintenance (6 weeks) Exercise: Supervised 1 hour PT sessions once every 3 weeks, 45-minute homework sessions three times a week.\n\nDiet: one final 30 minute session after week 3.",[9],[25],{"name":26,"affiliation":5,"role":27},"Ali Khavandi","PRINCIPAL_INVESTIGATOR",[29,34],{"name":30,"role":31,"phone":32,"phoneExt":18,"email":33},"Joanna Abramik","CONTACT","+44 1225 82109","joanna.abramik1@nhs.net",{"name":26,"role":31,"phone":35,"phoneExt":18,"email":36},"+44 1225 821174","ali.khavandi@nhs.net",[38,55],{"facility":5,"status":39,"city":40,"state":18,"zip":41,"country":42,"countryCode":43,"cosmosGeoPoint":44,"geoPoint":49,"contacts":50},"RECRUITING","Bath","BA1 3NG","United Kingdom","UK",{"type":45,"coordinates":46},"Point",[47,48],-2.36172,51.3751,{"lat":48,"lon":47},[51,52,54],{"name":26,"role":31,"phone":35,"phoneExt":18,"email":36},{"name":30,"role":31,"phone":53,"phoneExt":18,"email":33},"+44 1225 826192",{"name":30,"role":27,"phone":18,"phoneExt":18,"email":18},{"facility":56,"status":39,"city":57,"state":18,"zip":58,"country":42,"countryCode":43,"cosmosGeoPoint":59,"geoPoint":63,"contacts":64},"University Hospitals Bristol and Weston NHS Foundation Trust","Bristol","BS2 8ED",{"type":45,"coordinates":60},[61,62],-2.59665,51.45523,{"lat":62,"lon":61},[65,69,71,72],{"name":66,"role":31,"phone":67,"phoneExt":18,"email":68},"Mark Mariathas","+441173426573","mark.mariathas@uhbw.nhs.uk",{"name":30,"role":31,"phone":18,"phoneExt":18,"email":70},"joanna.abramik@uhbw.nhs.uk",{"name":66,"role":27,"phone":18,"phoneExt":18,"email":18},{"name":30,"role":73,"phone":18,"phoneExt":18,"email":18},"SUB_INVESTIGATOR",{"type":75,"investigatorFullName":18,"investigatorTitle":18,"investigatorAffiliation":18,"oldNameTitle":18,"oldOrganization":18},"SPONSOR",[77],{"name":78,"class":79},"National Institute for Health Research, United Kingdom","OTHER_GOV","100568489","microvascular-coronary-rehabilitation-for-improving-treatment---feasibility-study-100568489",false,"NCT06681896","Microvascular Coronary Rehabilitation For Improving Treatment - Feasibility Study","MICROFIT","Inclusion Criteria:\n\n* Age ≥18\n* Angina or angina equivalent symptoms\n* Unobstructed coronary arteries at the time of coronary angiogram. This will be defined as plaque causing \\\u003C40% epicardial vessel stenosis or 40-90% with a fractional flow reserve (FFR) ≥0.8\n* Evidence of microvascular dysfunction on ICA (CFR \\\u003C2.5 and\u002For AchFR \\\u003C1.5)\n\nExclusion Criteria:\n\n* New York Heart Association class III\u002FIV heart failure\n* Severe left ventricular impairment (ejection fraction≤35%)\n* Severe heart valve disease\n* Significant cardiomyopathy (as assessed by a cardiologist)\n* Severe hypertension (defined as blood pressure \\>180\u002F120mmHg (despite three anti-hypertensive agents)\n* Uncontrolled arrhythmia\n* A history of aortic dissection, recent (\\\u003C6 months) acute pulmonary embolus, deep vein thrombosis, stroke or transient ischaemic attack, severe autonomic or peripheral neuropathy, acute systemic illness or fever, severe acute or chronic renal failure, severe pulmonary fibrosis or interstitial lung disease (in line with other trials investigating HIIT exercise)\n* Pregnancy or breastfeeding (at any point during the study. Patients becoming pregnant during the study will be asked to withdraw due to additional radiation exposure and risks from HIIT)\n* Physical inability to participate in exercise\n* Significant claustrophobia or metallic implants which would limit MRI imaging\n* Intolerance to regadenoson testing (high degree atrioventricular block, severe asthma or airways disease)\n* Current participation in another intervention-based trial\n* Inability to fully understand the verbal and written descriptions of the study and instructions provided during the study duration.","ALL","18 Years",{"count":90,"type":91},40,"ESTIMATED","INTERVENTIONAL",[94],"NA","The goal of this clinical trial is to assess the feasibility of undertaking a randomized controlled trial assessing the impact of a personalised, intense cardiac rehabilitation programme involving high intensity interval exercise (HIIT) and dietary advice (termed MICROFIT) on symptom burden in patients with microvascular coronary dysfunction.\n\nThe main questions it aims to answer are:\n\n1. Feasibility of undertaking randomised controlled trial of MICROFIT in patients with coronary microvascular dysfunction (recruitment rates, retention and adherence, acceptability of MICROFIT and participants' and practitioners' experiences of trial participation)\n2. Preliminary data on the effect that MICROFIT has on angina symptoms in patients with microvascular coronary dysfunction, as measured by Seattle Angina Questionnaire\n3. Preliminary data on the fidelity and clinical efficacy of MICROFIT\n\nParticipants will be randomized to either MICROFIT + Usual Care, or Usual Care group.\n\nParticipants in both arms of the trial will:\n\n* Undergo a series of investigations, including cardiopulmonary exercise test (CPET), dual xray absorptiometry (DEXA), echocardiogram, cardiac MRI scan, blood tests, at the start of the trial and again after 6 months\n* Measure their living activity by using an activity tracker (GeneActiv) as well as a photographic diet diary for a week at the start of the trial and again after 6 months\n* Complete a series of questionnaires to assess angina symptom burden, mental health and quality of life, at the start of the trial and again after 6 months.\n\nParticipants in the intervention arm of the study will:\n\n1. Undergo MICROFIT intervention. MICROFIT includes a combination of exercise and diet management sessions over 24 weeks. It involves:\n\n   * 1:1 high-intensity interval training ('HIIT') sessions with a personal trainer and guidance on exercise sessions to be performed at home\n   * 1:1 sessions with a dietician to support them with improvements in diet.\n2. Visit clinic on two additional occassions during the trial to discuss their progress with a cardiologist\n3. Undergo an interview at the end of the study to discuss their experiences of participation in the study\n4. Receive a debrief on their investigation results and progress made at the end of their study\n\nParticipants in the Usual Care arm of the study will:\n\n1. Receive standard Usual Care advice regarding lifestyle changes and targeted medical therapy offered to patients with coronary microvascular dysfunction.\n2. Receive a debrief on their investigation results and progress made at the end of their study\n3. Undergo a 'taster' session with the personal trainer to discover what the intervention involves.",[97,98,99],"Microvascular Coronary Dysfunction","Microvascular Angina","Coronary Microvascular Dysfunction (CMD)",[101,102,103,104,105,106,107],"coronary microvascular dysfunction","HIIT","high intensity interval exercise training","exercise training","dietary rehabilitation","lifestyle advice","microvascular angina","2025-06-17",{"date":110,"type":111},"2025-06-18","ACTUAL",{"date":113,"type":111},"2024-11-12",{"date":115,"type":91},"2027-01-01",{"name":5,"class":6},2]