protocolSection identificationModule nctId: NCT06279585, orgStudyIdInfo id: ECA GVHD, briefTitle: Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-09, studyFirstPostDateStruct date: 2024-02-28, lastUpdatePostDateStruct date: 2024-02-28, sponsorCollaboratorsModule leadSponsor name: University of Seville, class: OTHER, descriptionModule briefSummary: Allogeneic Hematopoietic Stem Cell Transplantation (alloHSCT) represents the only curative option for many patients diagnosed with various hematologic neoplasms. Procedure-related morbidity and mortality pose challenges to long-term outcomes and quality of life, especially among patients who develop chronic graft-versus-host disease (cGVHD). There is a gap in healthcare that comprehensively addresses the specific needs of these patients. Physical therapy as an adjuvant treatment, through therapeutic exercise involving muscle strength and cardiorespiratory endurance, has shown positive influences on health markers and serves as a strong medical ally in similar profiles. Although these strategies could be reproducible and potentially beneficial for cGVHD patients, research has been limited to date, with the role of physical therapy possibly underutilized in this field. Justification: Unaddressed medical gap with no rigorously scientific responses specific to cGVHD. Objectives: This project aims to conduct the first randomized clinical trial from a physical therapy perspective as an adjuvant treatment for patients undergoing alloHSCT diagnosed with cGVHD., conditionsModule conditions: Graft-versus-host-disease, conditions: Graft Versus Host Disease, Chronic, conditions: Stem Cell Transplant Complications, conditions: Hematological Malignancy, conditions: Hematologic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: Physical therapy, outcomesModule primaryOutcomes measure: Health-related quality of life, primaryOutcomes measure: Chronic Graft-Versus-Host Disease (cGVHD) symptom burden, secondaryOutcomes measure: Muscular strength, secondaryOutcomes measure: Cardiorespiratory fitness, secondaryOutcomes measure: Functional status, secondaryOutcomes measure: Distress, secondaryOutcomes measure: Mood, secondaryOutcomes measure: Anxiety, secondaryOutcomes measure: Biological markers, secondaryOutcomes measure: Responses to medical treatment, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Seville; Manuel Siurot Avenue, no number, city: Seville, zip: 41013, country: Spain, contacts name: Raquel P Aguilar, Ph.D.cand., role: CONTACT, phone: 955 013 260, phoneExt: 34, email: raquelijorml@gmail.com, contacts name: José Antonio P Simón, PhD, role: CONTACT, phone: 955 013 260, phoneExt: 34, email: josea.perez.simon.sspa@juntadeandalucia.es, geoPoint lat: 37.38283, lon: -5.97317, hasResults: False