Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

NCT ID: NCT06279585

Last Updated: 2024-02-28

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-03-01
• Study Completion Date: 2025-09-30

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.

Conditions

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Experimental group

Participants from both groups will undergo the three assessments and receive standard medical care.The patients in the experimental group will participate, at Time T1 (week 1 to 12), in a 12-week physiotherapy treatment program consisting of a total of 38 sessions: 2 health education sessions, 24 supervised combined exercise sessions, and 12 self-administered complementary exercise sessions.

Group Type: EXPERIMENTAL

Physical therapy

Intervention Type: OTHER

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

Control group

Participants from both groups will undergo the three assessments and receive standard medical care.

The Control Group (GC), externally to the trial itself, for ethical reasons, considering potential benefits without risks, and as a strategy for blinding the study itself, will carry out the physiotherapy treatment program following the final assessment of the study, becoming a hybrid program under the same protocol.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Physical therapy

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Seville

OTHER

Sponsor Role: lead

Responsible Party

Raquel Perez Aguilar

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

José Antonio P Simón, PHD

Role: STUDY_DIRECTOR

Chief of Hematology at Virgen del Rocío University Hospital.

Locations

University of Seville; Manuel Siurot Avenue, no number

Seville, , Spain

Countries

Spain

Central Contacts

Raquel P Aguilar, PhDcand

Role: CONTACT

raquelijorml@gmail.com

955 013 260 ext. +34

José Antonio P Simón, PHD

Role: CONTACT

josea.perez.simon.sspa@juntadeandalucia.es

955 013 260 ext. +34

Facility Contacts

Raquel P Aguilar, Ph.D.cand.

Role: primary

raquelijorml@gmail.com

955 013 260 ext. 34

José Antonio P Simón, PhD

Role: backup

josea.perez.simon.sspa@juntadeandalucia.es

955 013 260 ext. 34

Other Identifiers

ECA GVHD

Identifier Type: -

Identifier Source: org_study_id