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Trial Title:
Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD
NCT ID:
NCT06279585
Condition:
Graft-versus-host-disease
Graft Versus Host Disease, Chronic
Stem Cell Transplant Complications
Hematological Malignancy
Hematologic Cancer
Conditions: Official terms:
Hematologic Neoplasms
Bronchiolitis Obliterans Syndrome
Graft vs Host Disease
Conditions: Keywords:
Hematopoietic Stem Cell Transplantation
Graft versus host disease
Physiotherapy
Rehabilitation
Physical therapy
Exercise
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Double (Participant, Investigator)
Intervention:
Intervention type:
Other
Intervention name:
Physical therapy
Description:
Health education sessions and combined therapeutic exercise sessions, based on muscular
strength training and cardiorespiratory endurance.
Arm group label:
Experimental group
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.
Detailed description:
Design: Prospective controlled clinical trial.
Location: Virgen del Rocío University Hospital, Hematology Unit.
Statistical analysis plan:The data will be analyzed using SPSS v.26 software for Windows
and Epidat 4.2. All statistical tests will be conducted considering a 95% confidence
interval (p-value <0.05). To compare the score of the main outcome measure, quality of
life (score range 0-200), between the experimental and control groups, the t-test or
Mann-Whitney test will be employed (depending on the normality of the data). The
comparison will be conducted at three time points (T0, T1, and T2). Furthermore,
multivariate analysis will be performed using generalized equations of repeated measures
to determine score changes between the groups. Since it is a Likert scale-based score,
the Friedman test will be used to compare score changes, employing the Bonferroni test
for pairwise comparisons.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients with chronic Graft-Versus-Host Disease (cGVHD) treated at Virgen del Rocío
University Hospital will be invited to participate in the trial (n=108), under the
following eligibility criteria: Inclusion criteria:
- Adult (18 years or older); Underwent allogeneic hematopoietic stem cell
transplantation (alloHSCT) diagnosed with cGVHD; No medical contraindication for
moderate or high-intensity exercise; Proficiency in the Spanish language; Have
access to the internet.
Exclusion Criteria:
- Unable to perform initial or final physical assessments; Having serious pre-existing
conditions before the oncological diagnosis or diseases that are not or poorly
controlled; Not signing or delivering the informed consent on the indicated date.
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Seville; Manuel Siurot Avenue, no number
Address:
City:
Seville
Zip:
41013
Country:
Spain
Contact:
Last name:
Raquel P Aguilar, Ph.D.cand.
Phone:
955 013 260
Phone ext:
34
Email:
raquelijorml@gmail.com
Contact backup:
Last name:
José Antonio P Simón, PhD
Phone:
955 013 260
Phone ext:
34
Email:
josea.perez.simon.sspa@juntadeandalucia.es
Start date:
March 1, 2024
Completion date:
September 2025
Lead sponsor:
Agency:
University of Seville
Agency class:
Other
Source:
University of Seville
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06279585
