Clinical trial NCT06279585: Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD
Official title: Physical Therapy in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation With a Diagnosis of Chronic Graft-versus-host Disease: A Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Graft-versus-host-disease
Graft Versus Host Disease, Chronic
Stem Cell Transplant Complications
Hematological Malignancy
Hematologic Cancer
Keywords: Hematopoietic Stem Cell Transplantation
Graft versus host disease
Physiotherapy
Rehabilitation
Physical therapy
Exercise
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2024-02-28
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Primary outcomes:
measure: Health-related quality of life
timeFrame: Week 1, Week 6, and Week 13
measure: Chronic Graft-Versus-Host Disease (cGVHD) symptom burden
timeFrame: Week 1, Week 6, and Week 13
Secondary outcomes:
measure: Muscular strength
timeFrame: Week 1, Week 6, and Week 13
measure: Cardiorespiratory fitness
timeFrame: Week 1, Week 6, and Week 13
measure: Functional status
timeFrame: Week 1, Week 6, and Week 13
measure: Distress
timeFrame: Week 1, Week 6, and Week 13
measure: Mood
timeFrame: Week 1, Week 6, and Week 13
measure: Anxiety
timeFrame: Week 1, Week 6, and Week 13
measure: Biological markers
timeFrame: Week 1, Week 6, and Week 13
measure: Responses to medical treatment
timeFrame: Week 1, Week 6, and Week 13
Other outcomes:
Locations:
city: Seville
country: Spain
facility: University of Seville; Manuel Siurot Avenue, no number
Study officials:
affiliation: Chief of Hematology at Virgen del Rocío University Hospital.
name: José Antonio P Simón, PHD
role: STUDY_DIRECTOR
References: