[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100659991":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":19,"armGroups":26,"interventions":38,"overallOfficials":19,"centralContacts":51,"locations":61,"responsibleParty":77,"collaborators":19,"id":79,"slug":80,"hasResults":81,"nctId":82,"briefTitle":83,"officialTitle":84,"acronym":85,"eligibilityCriteria":86,"healthyVolunteers":81,"sex":87,"minAge":88,"maxAge":89,"enrollmentInfo":90,"targetDuration":19,"studyType":93,"phases":94,"briefSummary":96,"conditions":97,"keywords":19,"overallStatus":64,"whyStopped":19,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"The Mediterranean Institute for Transplantation and Advanced Specialized Therapies","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change From Baseline to 6 Months in Health-Related Quality of Life Assessed by the 36-Item Short Form Health Survey (SF-36)","Health-related quality of life will be assessed using the 36-Item Short Form Health Survey (SF-36). Scores range from 0 to 100, with higher scores indicating better health-related quality of life. The outcome measure is the change in score from baseline to 6 months after randomization.","Baseline to 6 months",{"measure":14,"description":15,"timeFrame":12},"Change From Baseline to 6 Months in Psychological Distress Assessed by the Distress Thermometer","Psychological distress will be assessed using the Distress Thermometer. Scores range from 0 to 10, with higher scores indicating greater psychological distress. The outcome measure is the change in score from baseline to 6 months after randomization.",{"measure":17,"description":18,"timeFrame":12},"Change From Baseline to 6 Months in Sleep Quality Assessed by the Pittsburgh Sleep Quality Index (PSQI)","Sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI). Total scores range from 0 to 21, with higher scores indicating worse sleep quality. The outcome measure is the change in score from baseline to 6 months after randomization.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":19,"primaryPurpose":23,"observationalModel":19,"timePerspective":19,"maskingInfo":24},"RANDOMIZED","PARALLEL","SUPPORTIVE_CARE",{"masking":25,"maskingDescription":19,"whoMasked":19},"NONE",[27,35],{"label":28,"type":29,"description":30,"interventionNames":31},"Multidisciplinary program (acupuncture + telerehabilitation + brain health)","EXPERIMENTAL","Participants will receive a multidisciplinary non-pharmacological intervention consisting of acupuncture, telerehabilitation-based physical rehabilitation, and psychological support. The intervention is designed to improve health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients at least one year after transplantation.",[32,33,34],"Procedure: Acupuncture","Behavioral: Telerehabilitation-Based Physical Rehabilitation","Behavioral: Psychological Support Program",{"label":36,"type":37,"description":19,"interventionNames":19},"Standard of care","NO_INTERVENTION",[39,44,48],{"type":40,"name":41,"description":42,"armGroupLabels":43,"otherNames":19},"PROCEDURE","Acupuncture","A multidisciplinary non-pharmacological intervention including acupuncture, telerehabilitation-based physical rehabilitation, and psychological support aimed at improving health-related quality of life (HRQoL) and psychophysical well-being in solid organ transplant recipients.",[28],{"type":45,"name":46,"description":42,"armGroupLabels":47,"otherNames":19},"BEHAVIORAL","Telerehabilitation-Based Physical Rehabilitation",[28],{"type":45,"name":49,"description":42,"armGroupLabels":50,"otherNames":19},"Psychological Support Program",[28],[52,57],{"name":53,"role":54,"phone":55,"phoneExt":19,"email":56},"Giada Pietrosi","CONTACT","+39 0912192111","gpietrosi@ismett.edu",{"name":58,"role":54,"phone":59,"phoneExt":19,"email":60},"Monica Rizzo","+39 0912192692","morizzo@ismett.edu",[62],{"facility":63,"status":64,"city":65,"state":65,"zip":66,"country":67,"countryCode":68,"cosmosGeoPoint":69,"geoPoint":74,"contacts":75},"IRCCS ISMETT - Istituto Mediterraneo per i Trapianti e le Terapie ad Alta Specializzazione","RECRUITING","Palermo","90127","Italy","IT",{"type":70,"coordinates":71},"Point",[72,73],13.3636,38.1166,{"lat":73,"lon":72},[76],{"name":53,"role":54,"phone":55,"phoneExt":19,"email":56},{"type":78,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100659991","multidisciplinary-non-pharmacological-intervention-to-improve-quality-of-life-in-solid-organ-transplant-recipients-100659991",false,"NCT07870811","Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients","Integrated Multidisciplinary Non-Pharmacological Treatment for Improving Health-Related Quality of Life in Solid Organ Transplant Recipients: A Randomized Single-Center Pilot Study","TAO","Inclusion Criteria:\n\n* Age ≥ 25 years and ≤ 65 years;\n* Solid organ transplantation (liver, kidney, heart, or lung) performed at least 1 year prior to enrollment, with good graft functional recovery according to organ-specific criteria;\n* Ability to understand and independently complete questionnaires;\n* Ability to provide written informed consent;\n* Absence of clinical contraindications to therapeutic exercise;\n* Adequate cognitive status;\n* SF-36 score \\\u003C 50 or Distress Thermometer (DT) score ≥ 4 and Pittsburgh Sleep Quality Index (PSQI) score ≥ 5.\n\nExclusion Criteria:\n\n* Diagnosis of severe cognitive impairment, acute psychiatric illness, or significant hearing or visual disability;\n* Severe ongoing complications or comorbidities that would prevent participation in the physiotherapy program;\n* Unstable immunosuppressive therapy and\u002For evidence of ongoing graft rejection;\n* Diagnosis of active malignancy;\n* Pregnancy.","ALL","25 Years","65 Years",{"count":91,"type":92},140,"ESTIMATED","INTERVENTIONAL",[95],"NA","This is a single-center interventional study aimed at evaluating the feasibility of a multidisciplinary non-pharmacological approach based on acupuncture, telerehabilitation-based physical rehabilitation, and brain health programs to improve health-related quality of life (HRQoL) and psychophysical well-being in patients who have undergone solid organ transplantation (SOT) at least one year earlier, as well as to provide a preliminary estimate of its effects.\n\nSolid organ transplantation (SOT) is currently the most effective treatment, and often the only available option, for end-stage organ failure. Although transplantation can lead to a restitutio ad integrum from a clinical perspective, the quality of life of transplant recipients, regardless of the transplanted organ, frequently remains lower than that of the general population.\n\nThis project stems from the clinical, social, and scientific need to provide a concrete response to this challenge through the implementation of functional, reproducible, and economically sustainable rehabilitation pathways aimed at improving HRQoL in solid organ transplant recipients. The proposed approach is based on an innovative multidisciplinary model integrating telerehabilitation, acupuncture, and cognitive stimulation. Such a structured model of care may not only improve patients' quality of life and subjective well-being, but also represent an effective strategy for comprehensive post-transplant management by helping reduce complications, prevent cognitive decline, and promote a more person-centered, sustainable, and humane approach to care.",[98,99,100,101],"Heart Transplant Patients","Kidney Transplant Patients","Lung Transplant","Liver Transplanted Patients","2026-10-06",{"date":104,"type":105},"2026-10-13","ACTUAL",{"date":107,"type":105},"2026-04-27",{"date":109,"type":92},"2026-10-21",{"name":5,"class":6},1]