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Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

NCT06279585 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 108

Last updated 2024-02-28

No results posted yet for this study

Summary

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.

Conditions

  • Graft-versus-host-disease
  • Graft Versus Host Disease, Chronic
  • Stem Cell Transplant Complications
  • Hematological Malignancy
  • Hematologic Cancer

Interventions

OTHER

Physical therapy

Health education sessions and combined therapeutic exercise sessions, based on muscular strength training and cardiorespiratory endurance.

Sponsors & Collaborators

  • University of Seville

    lead OTHER

Principal Investigators

  • José Antonio P Simón, PHD · Chief of Hematology at Virgen del Rocío University Hospital.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-03-01
Primary Completion
2024-12-31
Completion
2025-09-30

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06279585 on ClinicalTrials.gov