[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100617514":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":45,"centralContacts":50,"locations":59,"responsibleParty":85,"collaborators":31,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":31,"eligibilityCriteria":92,"healthyVolunteers":89,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":31,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":107,"overallStatus":111,"whyStopped":31,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Marmara University","OTHER",[8,15,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Intermittent Pneumatic Compression + Home-Based Walking Program","EXPERIMENTAL","Participants in this group will receive 15 sessions of intermittent pneumatic compression (IPC) therapy combined with a home-based walking program for 10 weeks. IPC will be applied 3 times per week at 50 mmHg pressure for 30 minutes using the DoctorLife LX7 Max device. Participants will also be instructed to walk at least 10,000 steps daily, monitored via a validated pedometer mobile application (PACER). Exercise adherence will be supported through follow-up and exercise diaries.",[13,14],"Device: Intermittent Pneumatic Compression (IPC)","Behavioral: Home-Based Walking Program",{"label":16,"type":10,"description":17,"interventionNames":18},"Intermittent Pneumatic Compression + High-Intensity Interval Training (HIIT)","This group will receive 15 sessions of IPC therapy and 30 sessions of supervised high-intensity interval training (HIIT) performed on a stationary cycle ergometer. The program will last 10 weeks (3 sessions per week). Each session will include a 5-minute warm-up, seven 1-minute high-intensity intervals (with 1-minute active recovery periods), and a 5-minute cool-down, for a total of 23 minutes. Exercise intensity will be individually determined using the Graded Cycling Test with Talk Test (GCT-TT), corresponding to Borg scale 14-16 for intervals. Participants will be continuously monitored for heart rate, rhythm, oxygen saturation, and blood pressure during exercise.",[13,19],"Behavioral: High-Intensity Interval Training (HIIT)",{"label":21,"type":10,"description":22,"interventionNames":23},"Intermittent Pneumatic Compression + Moderate-Intensity Continuous Training (MICT)","This group will receive 15 sessions of IPC therapy and 30 sessions of supervised moderate-intensity continuous training (MICT) over 10 weeks. Each session (55 minutes total) will consist of a 5-minute warm-up, 45 minutes of steady-state cycling at 50% of maximal power output (from the GCT-TT), and a 5-minute cool-down. The corresponding effort equates to Borg scale 12. Sessions will occur 3 times per week under physiotherapist supervision with continuous monitoring of vital signs.",[13,24],"Behavioral: Moderate-Intensity Continuous Training (MICT)",[26,32,37,41],{"type":27,"name":28,"description":29,"armGroupLabels":30,"otherNames":31},"DEVICE","Intermittent Pneumatic Compression (IPC)","Applied to both lower limbs for 30 minutes at 50 mmHg, 3 times per week for 5 weeks using DoctorLife LX7 Max device. Used in all study arms.",[16,9,21],null,{"type":33,"name":34,"description":35,"armGroupLabels":36,"otherNames":31},"BEHAVIORAL","Home-Based Walking Program","Participants perform ≥10,000 steps\u002Fday using PACER pedometer app; encouraged through exercise logs and follow-up.",[9],{"type":33,"name":38,"description":39,"armGroupLabels":40,"otherNames":31},"High-Intensity Interval Training (HIIT)","Supervised cycling-based interval exercise, 3×\u002Fweek for 10 weeks, individualized by GCT-TT protocol.",[16],{"type":33,"name":42,"description":43,"armGroupLabels":44,"otherNames":31},"Moderate-Intensity Continuous Training (MICT)","Supervised continuous cycling exercise, 3×\u002Fweek for 10 weeks, at 50% GCT-TT power output.",[21],[46],{"name":47,"affiliation":48,"role":49},"Yeliz BAHAR ÖZDEMİR, Associate Professor","Marmara University Pendik Training and Research Hospital","STUDY_DIRECTOR",[51,56],{"name":52,"role":53,"phone":54,"phoneExt":31,"email":55},"Yeliz BAHAR ÖZDEMİR, MD, Associate Professor","CONTACT","+90 216 625 45 45","yeliz.ozdemir@marmara.edu.tr",{"name":57,"role":53,"phone":54,"phoneExt":31,"email":58},"Gökçenur Yalçın, MD, Specialist Physician","gokcenur.yalcin@marmara.edu.tr",[60],{"facility":61,"status":31,"city":62,"state":62,"zip":63,"country":64,"countryCode":31,"cosmosGeoPoint":65,"geoPoint":70,"contacts":71},"Marmara University Pendik Training and Research Hospital, Department of Physical Medicine and Rehabilitation","Istanbul","34899","Turkey (Türkiye)",{"type":66,"coordinates":67},"Point",[68,69],28.94966,41.01384,{"lat":69,"lon":68},[72,74,75,78,81,83],{"name":73,"role":53,"phone":54,"phoneExt":31,"email":55},"Yeliz Bahar Özdemir, MD, Associate Professor",{"name":57,"role":53,"phone":54,"phoneExt":31,"email":58},{"name":76,"role":77,"phone":31,"phoneExt":31,"email":31},"Yeliz Bahar Özdemir, Associate Professor","PRINCIPAL_INVESTIGATOR",{"name":79,"role":80,"phone":31,"phoneExt":31,"email":31},"Gökçenur Yalçın, Specialist Physician","SUB_INVESTIGATOR",{"name":82,"role":80,"phone":31,"phoneExt":31,"email":31},"Ecem Avukat, Resident Physician",{"name":84,"role":80,"phone":31,"phoneExt":31,"email":31},"İpek Uyanık, Resident Physician",{"type":86,"investigatorFullName":31,"investigatorTitle":31,"investigatorAffiliation":31,"oldNameTitle":31,"oldOrganization":31},"SPONSOR","100617514","investigation-of-the-effects-of-high-intensity-interval-exercise-and-moderate-intensity-continuous-exercise-on-limb-volume-functional-capacity-and-quality-of-life-in-patients-with-lipedema-100617514",false,"NCT07319611","Investigation of the Effects of High-Intensity Interval Exercise and Moderate-Intensity Continuous Exercise on Limb Volume, Functional Capacity, and Quality of Life in Patients With Lipedema","Inclusion Criteria:\n\n* Female participants aged 18-65 years\n* Able to read and write (literate)\n* Clinically diagnosed with lipedema according to Halk and Damstra criteria\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Illiteracy\n* Refusal or inability to provide written\u002Fsigned consent\n* Lower extremity fracture, trauma, or surgery within the past 12 months\n* Cardiopulmonary diseases that contraindicate exercise participation\n* Development of intolerance exercise sessions","FEMALE","18 Years","65 Years",{"count":97,"type":98},69,"ESTIMATED","INTERVENTIONAL",[101],"NA","This randomized controlled clinical study aims to investigate and compare the effects of high-intensity interval training (HIIT) and moderate-intensity continuous training (MICT), when combined with intermittent pneumatic compression (IPC) therapy, on limb volume, functional capacity, pain, fatigue, anxiety, depression, sleep quality, and quality of life in women with lipedema.\n\nLipedema is a chronic, progressive adipose tissue disorder primarily affecting women, characterized by abnormal and symmetrical fat accumulation in the lower extremities that does not improve with weight loss or limb elevation. It is often misdiagnosed as obesity or lymphedema, leading to delayed treatment. Lipedema causes pain, swelling, bruising, mobility limitation, and reduced quality of life.\n\nConservative treatment options include compression therapy, manual lymphatic drainage, and exercise. IPC is a non-invasive treatment used to reduce limb volume and pain while improving function and quality of life. Exercise is also a cornerstone of conservative management, but the optimal exercise intensity for lipedema remains unclear.\n\nIn this study, 69 female patients aged 18-65 years diagnosed with lipedema according to Halk and Damstra criteria will be randomly assigned into three groups:\n\nIPC + Home-based walking program\n\nIPC + High-Intensity Interval Training (HIIT)\n\nIPC + Moderate-Intensity Continuous Training (MICT)\n\nAll participants will receive 15 IPC sessions (3 times per week for 5 weeks). The exercise programs (HIIT or MICT) will continue for 10 weeks, supervised by a physiotherapist. The home-based group will be encouraged to walk ≥10,000 steps daily using a pedometer application.\n\nPrimary outcome: Change in limb volume measured by circumferential measurements and the truncated cone formula.\n\nSecondary outcomes: Pain (VAS), functional capacity (6-Minute Walk Test), muscle strength (dynamometry), pressure pain threshold (algometry), physical activity (IPAQ-SF), lower extremity function (LEFS), quality of life (SF-12), sleep quality (PSQI), fatigue (FSS), and anxiety\u002Fdepression (HADS).\n\nMeasurements will be taken at baseline (T0), after 15 IPC sessions (T1), and after 30 total sessions or 10 weeks (T2).\n\nThe investigators hypothesize that both HIIT and MICT combined with IPC will provide superior improvements in physical and psychological outcomes compared to IPC with a home-based walking program alone.",[104,105,106],"Lipedema","Exercise Therapy","High Intensity Interval Training",[108,109,110],"lipedema","high intensity interval training","moderate intensity continuous training","NOT_YET_RECRUITING","2025-12-20",{"date":114,"type":115},"2026-01-06","ACTUAL",{"date":117,"type":98},"2025-12-25",{"date":119,"type":98},"2026-07-01",{"name":5,"class":6},1]