[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100601331":3},{"organization":4,"outcomesModule":7,"designInfo":59,"detailedDescription":11,"studyPopulation":11,"armGroups":66,"interventions":81,"overallOfficials":11,"centralContacts":100,"locations":106,"responsibleParty":125,"collaborators":11,"id":128,"slug":11,"hasResults":129,"nctId":130,"briefTitle":131,"officialTitle":132,"acronym":11,"eligibilityCriteria":133,"healthyVolunteers":129,"sex":134,"minAge":135,"maxAge":136,"enrollmentInfo":137,"targetDuration":11,"studyType":140,"phases":141,"briefSummary":143,"conditions":144,"keywords":146,"overallStatus":153,"whyStopped":11,"lastUpdateSubmitDate":154,"lastUpdatePostDateStruct":155,"startDateStruct":158,"completionDateStruct":160,"leadSponsor":162,"locationsCount":163},{"fullName":5,"class":6},"Universiti Sains Malaysia","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":29,"otherOutcomes":11},[9,13,15,19,23,26],{"measure":10,"description":11,"timeFrame":12},"Glycated haemoglobin (HbA1C)",null,"Baseline and post-intervention at 10 weeks",{"measure":14,"description":11,"timeFrame":12},"Lipid profile",{"measure":16,"description":17,"timeFrame":18},"Maximal voluntary contraction (MVC)","isometric quadriceps peak torque (QPT) and isokinetic QPT","Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks).",{"measure":20,"description":21,"timeFrame":22},"Exercise capacity","6-minute walk test (6-MWT)","Baseline, mid-intervention (6 weeks), and post-intervention (10 weeks)",{"measure":24,"description":25,"timeFrame":22},"13-item Revised Version of Diabetes Quality of Life (RV-DQOL13)","Scores range from 13 to 65, with higher scores reflecting reduced quality of life",{"measure":27,"description":28,"timeFrame":22},"Short Form-12 (SF-12) health survey","Scoring ranges from 0 to 100, with higher scores indicating better physical and mental health.",[30,33,37,39,43,46,49,52,55],{"measure":31,"description":32,"timeFrame":22},"Electromyography (EMG) for muscle activity assessment","To assess quadriceps muscle activity (rectus femoris, vastus medialis oblique, and vastus lateralis) during maximal voluntary contraction.",{"measure":34,"description":35,"timeFrame":36},"Blood pressure","systolic blood pressure (SBP), diastolic blood pressure (DBP),","Baseline and up to 10 weeks",{"measure":38,"description":11,"timeFrame":36},"Heart rate",{"measure":40,"description":41,"timeFrame":42},"Borg Category-Ratio scale (Borg CR-10)","The scale ranges from 0 (nothing at all) to 10 (extremely strong) to represent the participants' subjective feelings of breathlessness and leg fatigue.","Every cycling training session from week 1 to week 10",{"measure":44,"description":45,"timeFrame":22},"Body weight","Body weight in kilograms (kg)",{"measure":47,"description":48,"timeFrame":22},"Height","Height in centimeters (cm)",{"measure":50,"description":51,"timeFrame":22},"Body mass index (BMI)","BMI is calculated as weight (kg) divided by height (m²).",{"measure":53,"description":54,"timeFrame":22},"Body circumference","Measure the waist circumference (WC), hip circumference (HC), and thigh circumference (TC) in centimetres with a measuring tape.",{"measure":56,"description":57,"timeFrame":58},"The short version of the physical activity enjoyment scale (PACES-S)","Exercise enjoyment will be assessed using a five-point Likert scale (1 = strongly disagree to 5 = strongly agree), with total scores ranging from 4 to 20; higher scores indicate greater enjoyment.","Mid-intervention (6 weeks), and post-intervention (10 weeks)",{"allocation":60,"interventionModel":61,"interventionModelDescription":62,"primaryPurpose":63,"observationalModel":11,"timePerspective":11,"maskingInfo":64},"RANDOMIZED","PARALLEL","This study is an open-label, single-centre, parallel-group, three-arm, randomised controlled study.","PREVENTION",{"masking":65,"maskingDescription":11,"whoMasked":11},"NONE",[67,72,76],{"label":68,"type":69,"description":11,"interventionNames":70},"Moderate intensity eccentric cycling (MI-ECC)","EXPERIMENTAL",[71],"Other: Moderate-intensity eccentric cycling",{"label":73,"type":69,"description":11,"interventionNames":74},"High intensity eccentric cycling (HI-ECC)",[75],"Other: High-intensity eccentric cycling",{"label":77,"type":78,"description":11,"interventionNames":79},"Moderate intensity concentric cycling (MI-CON)","ACTIVE_COMPARATOR",[80],"Other: Moderate-intensity concentric cycling",[82,88,94],{"type":6,"name":83,"description":84,"armGroupLabels":85,"otherNames":86},"Moderate-intensity eccentric cycling","* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer.\n* The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).",[68],[87],"MI-ECC",{"type":6,"name":89,"description":90,"armGroupLabels":91,"otherNames":92},"High-intensity eccentric cycling","* This group will perform eccentric cycling exercise twice per week for ten weeks using the Cyclus2 standard eccentric ergometer.\n* The intensity will start at 80% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (80%-100% PPO).",[73],[93],"HI-ECC",{"type":6,"name":95,"description":96,"armGroupLabels":97,"otherNames":98},"Moderate-intensity concentric cycling","* This group will perform concentric cycling exercise twice per week for ten weeks using the Lode Excalibur sport ergometer.\n* The intensity will start at 60% of the peak power output (PPO) of the incremental concentric cycling test.\n* The intensity will progressively increase by 5% of PPO every 2 weeks (60%-80% PPO).",[77],[99],"MI-CON",[101],{"name":102,"role":103,"phone":104,"phoneExt":11,"email":105},"Syamimi Shamsuddin","CONTACT","+6045622024","syamimi.s@usm.my",[107],{"facility":108,"status":11,"city":109,"state":110,"zip":111,"country":112,"countryCode":113,"cosmosGeoPoint":114,"geoPoint":119,"contacts":120},"Cardio and Muscle Function Laboratory, Pusat Perubatan USM Bertam","Kepala Batas","Pulau Pinang","13200","Malaysia","MY",{"type":115,"coordinates":116},"Point",[117,118],100.4265,5.51707,{"lat":118,"lon":117},[121],{"name":122,"role":103,"phone":123,"phoneExt":11,"email":124},"Rabiatul Adawiah Abdul Rahman","+60193709614","rabiatuladawiah3105@gmail.com",{"type":126,"investigatorFullName":122,"investigatorTitle":127,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Principal Investigator","100601331",false,"NCT07109102","Long-Term Benefits of Eccentric Cycling Exercise in Patients With Type 2 Diabetes Mellitus","Exploring Long-Term Benefits of Eccentric Cycling Exercise on Physiological Responses, Exercise Capacity, and Quality of Life in Patients With Type 2 Diabetes Mellitus","Inclusion Criteria:\n\n* Male diagnosed with T2DM\n* Age 30 - 60 years old\n* Height ≥155cm (To ensure proper ergonomics, comfort and safety during cycling)\n* HbA1C level between 6-8%\n* No resistance exercise for ≤ 3 months before participating in the current study.\n* Physical inactivity (moderate to vigorous exercise ≤60 minutes weekly based on International Physical Activity Questionnaires-Short Form (IPAQ-SF))\n\nExclusion Criteria:\n\n* Acute illness or any foot ulcer, diabetic ulcer, retinopathy, kidney, musculoskeletal, cardiovascular, or neurological disorder that could impair exercise performance or pose a risk to participants during exercise.\n* Insulin injection","MALE","30 Years","60 Years",{"count":138,"type":139},30,"ESTIMATED","INTERVENTIONAL",[142],"NA","The goal of this interventional study is to evaluate the long-term benefits of eccentric (ECC) cycling exercise on physiological responses, exercise capacity, and quality of life (QoL) in patients with type 2 diabetes mellitus (T2DM). The main questions it aims to answer are:\n\n* What are the effects of ECC cycling compared to concentric (CON) cycling on physiological responses, exercise capacity, and QoL in patients with T2DM?\n* What are the differential effects of moderate- and high-intensity ECC cycling compared to CON cycling on physiological responses, exercise capacity, and QoL in patients with T2DM?\n\nResearchers will compare moderate- and high-intensity ECC cycling to CON cycling (conventional cycling) to see if ECC cycling can be a viable alternative or complement to existing exercise protocols for managing T2DM.\n\nParticipants will:\n\n* Undergo pre-, mid-, and post-intervention assessment\n* Perform either moderate- or high-intensity ECC cycling or moderate intensity CON cycling according to group randomisation by the researcher.\n* Start with two familiarisation sessions prior to the actual cycling training.\n* Perform cycling exercise twice per week for 10 weeks.",[145],"Type 2 Diabetes Mellitus (T2DM)",[147,148,149,150,151,152],"Eccentric cycling","eccentric exercise","exercise capacity","quality of life","physiological responses","Type 2 diabetes mellitus","NOT_YET_RECRUITING","2025-07-30",{"date":156,"type":157},"2025-08-07","ACTUAL",{"date":159,"type":139},"2025-08",{"date":161,"type":139},"2026-08",{"name":5,"class":6},1]