[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100609353":3},{"organization":4,"outcomesModule":7,"designInfo":25,"detailedDescription":24,"studyPopulation":24,"armGroups":32,"interventions":45,"overallOfficials":60,"centralContacts":64,"locations":72,"responsibleParty":87,"collaborators":89,"id":93,"slug":24,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":24,"eligibilityCriteria":98,"healthyVolunteers":94,"sex":99,"minAge":100,"maxAge":24,"enrollmentInfo":101,"targetDuration":24,"studyType":104,"phases":105,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":74,"whyStopped":24,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":121,"completionDateStruct":123,"leadSponsor":125,"locationsCount":126},{"fullName":5,"class":6},"Northumbria University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":24},[9,13,15],{"measure":10,"description":11,"timeFrame":12},"Feasibility of Intervention","Feasibility will be determined by the rate of screening, eligibility, recruitment, and retention at 12 and 24 weeks.","Baseline to 24 weeks",{"measure":10,"description":14,"timeFrame":12},"Feasibility will be determined by adherence to the intervention (number of sessions attended and completed)",{"measure":16,"description":17,"timeFrame":18},"Acceptability of Intervention","Participant acceptability will be determined through a qualitative process evaluation involving semi-structured interviews. The interviews will identify action mechanisms, examine experiences, barriers, facilitators, and behaviour change strategies, with a diverse sample to reflect varied demographics. Participants will be asked about their experience of participating in the study, thoughts, and attitudes towards the intervention.","Post 24 weeks",[20],{"measure":21,"description":22,"timeFrame":23},"Office and Ambulatory Blood Pressure","Blood pressure will be measured in mmHg via office and ambulatory methods. Office BP will be taken in a seated position in accordance with resting BP protocols. Ambulatory BP monitoring will be performed with a non-invasive oscillometric device placed on the nondominant arm and programmed to perform measurements every 15 minutes for 24 hours. The secondary outcome is the change in mmHg for systolic and diastolic blood pressure from baseline, 12 weeks, and 24 weeks.","Baseline to 24 weeks.",null,{"allocation":26,"interventionModel":27,"interventionModelDescription":28,"primaryPurpose":29,"observationalModel":24,"timePerspective":24,"maskingInfo":30},"RANDOMIZED","PARALLEL","Individuals who meet the study criteria and agree to participate will be randomly assigned to one of two parallel groups: (1) home-based isometric exercise and lifestyle advice intervention, or (2) lifestyle advice control group. Randomisation will be performed with minimisation for sex and the mean of 24-hour ambulatory systolic BP (≤140 mm Hg vs \\>140 mm Hg).","BASIC_SCIENCE",{"masking":31,"maskingDescription":24,"whoMasked":24},"NONE",[33,39],{"label":34,"type":35,"description":36,"interventionNames":37},"Home Based Isometric Exercise and Lifestyle Change Group","EXPERIMENTAL","Participants randomised to this group will undertake a remotely supervised 12-week home-based isometric exercise training intervention 3 times per week. The bilateral leg isometric exercise consists of 5-stage wall squat position determined by individual calculations at baseline. Rate of perceived exertion (RPE) will be monitored throughout the intervention and used to guide the squat stage position. Lifestyle change advice will be given in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.",[38],"Behavioral: Isometric Exercise and Lifestyle Change Advice",{"label":40,"type":41,"description":42,"interventionNames":43},"Lifestyle Change Control Group","ACTIVE_COMPARATOR","Participants randomised to this group will not receive any intervention other than lifestyle change advice in accordance with NICE guidelines for hypertension. Participants will receive a smartwatch (Huawei D2) to monitor their daily physical activity (step count) and record their home blood pressure.",[44],"Behavioral: Lifestyle Change Advice",[46,54],{"type":47,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"BEHAVIORAL","Isometric Exercise and Lifestyle Change Advice","The intervention consists of two distinct phases:\n\n• Intensive Phase (12 weeks) - a structured, high-support period involving three weekly supervised isometric exercise sessions and lifestyle change advice. The supervised exercise programme will consist of 4 × 2-minute bouts of wall squat exercise, with 2-minute rest periods between bouts. Participant squat height position will be based on individual calculations determined at baseline. Target rate of perceived exertion (RPE) for each bout will be:\n\n* Bout 1: RPE 4 (target range: 3.5-4.5)\n* Bout 2: RPE 5.5 (target range: 5-6)\n* Bout 3: RPE 7 (target range: 6.5-7.5)\n* Bout 4: RPE 8.5 (target range: 8-9) If the RPE falls outside the target zone for a given bout, participants will adjust their squat height accordingly.\n\nLifestyle change advice will be given in booklet form in accordance with current NICE guidelines for hypertension.\n\n• Maintenance Phase (12-24 weeks) - focus on sustaining exercise and lifestyle behaviour changes",[34],[52,53],"Static Strength Training","Behaviour Change",{"type":47,"name":55,"description":56,"armGroupLabels":57,"otherNames":58},"Lifestyle Change Advice","Lifestyle change advice given as per current standard care for hypertension",[40],[59],"Behavioural Change",[61],{"name":62,"affiliation":5,"role":63},"Gabriel Cucato, PhD","PRINCIPAL_INVESTIGATOR",[65,70],{"name":66,"role":67,"phone":68,"phoneExt":24,"email":69},"Helen Llewellyn, MSc","CONTACT","+447949026070","helen.llewellyn@northumbria.ac.uk",{"name":62,"role":67,"phone":24,"phoneExt":24,"email":71},"gabriel.cucato@northumbria.ac.uk",[73],{"facility":5,"status":74,"city":75,"state":24,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":85},"RECRUITING","Newcastle upon Tyne","NE1 8ST","United Kingdom","UK",{"type":80,"coordinates":81},"Point",[82,83],-1.61396,54.97328,{"lat":83,"lon":82},[86],{"name":66,"role":63,"phone":24,"phoneExt":24,"email":24},{"type":88,"investigatorFullName":24,"investigatorTitle":24,"investigatorAffiliation":24,"oldNameTitle":24,"oldOrganization":24},"SPONSOR",[90],{"name":91,"class":92},"HealthWorks Newcastle Upon Tyne","UNKNOWN","100609353",false,"NCT07213479","Feasibility and Acceptability of Isometric Exercise and Lifestyle Change for the Management of Hypertension","Feasibility and Acceptability of Remote Home-Based Isometric Exercise and Lifestyle Change for the Management of Hypertension","Inclusion Criteria:\n\n* Diagnosis of Arterial Hypertension (AH) in accordance with NICE guidelines.\n* Under pharmacological treatment for AH with antihypertensive drug, type and dose maintained for the previous four months.\n* Blood Pressure with values \\\u003C180 and \\\u003C110 mmHg for office systolic and diastolic BP, respectively.\n* Not currently engaged in any structured or supervised exercise training programme, including resistance, aerobic, or isometric exercise, defined as planned exercise performed ≥2 times per week at moderate or greater intensity, for at least three months prior to enrolment.\n* Written informed consent provided.\n\nExclusion Criteria:\n\n* Body mass index \\>35 kg\u002Fm2.\n* Presence of cardiovascular disease beyond hypertension.\n* Known orthopaedic, musculoskeletal, or neurological conditions that restrain isometric exercise execution.\n* Presence of secondary hypertension\n* Inability to follow verbal instructions or complete study protocol","ALL","18 Years",{"count":102,"type":103},70,"ESTIMATED","INTERVENTIONAL",[106],"NA","High blood pressure (hypertension) is a leading risk factor for cardiovascular diseases and may contribute to poor health and premature death. The purpose of this research is to learn if a home-based isometric exercise programme combined with lifestyle change advice is a practical and acceptable method for people diagnosed with hypertension to manage their condition. Isometric exercise involves a muscle contraction without movement of the limbs and previous research has shown this may be effective for reducing blood pressure. Therefore, this study will explore the experiences, thoughts, attitudes, and barriers to participation. It will also examine the effect the isometric exercise has on blood pressure.\n\nParticipants will undertake an isometric exercise programme using a wall squat position, 3 times per week, for 12 weeks. The exercise sessions will be completed at home with remote online supervision by an exercise professional. Lifestyle change advice will given in line with current guidelines to promote healthy behaviours to reduce high blood pressure. After 12 weeks, participants will be encouraged to continue with the wall squat exercise for a further 12-weeks unsupervised. Throughout the study, participants' blood pressure and daily activity will be recorded using a smartwatch device.\n\nUpon completion of the intervention period, participants will be interviewed to gather their views and opinions on the isometric exercise programme. Changes in blood pressure will be evaluated at 12 and 24 weeks.\n\nBy exploring whether an isometric exercise programme is a feasible and acceptable method for hypertensive people to manage their condition and how this influences blood pressure, this research may aid in the development of a strategy to manage hypertension.",[109],"Hypertension (HTN)",[111,112,113,114,115,116],"Hypertension","Isometric Exercise","Wall Squat","Cardiovascular Disease","Lifestyle Change","Blood Pressure","2026-02-05",{"date":119,"type":120},"2026-02-06","ACTUAL",{"date":122,"type":120},"2026-02-02",{"date":124,"type":103},"2028-02",{"name":5,"class":6},1]