Neoplasms

Blood and Lymph Conditions

All Conditions

Immune System Diseases

Symptoms and General Pathology

Infections

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Hematologic Neoplasms

Graft vs Host Disease

Syndrome

Bronchiolitis

Bronchiolitis Obliterans Syndrome

Bronchiolitis Obliterans

Hematologic Diseases

Pneumonia

Organizing Pneumonia

Bronchitis

Bronchial Diseases

Respiratory Tract Diseases

Lung Diseases, Obstructive

Lung Diseases

Chronic Graft Versus Host Disease

Homologous Wasting Disease

Bronchiolitis Obliterans Organizing Pneumonia

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.

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.

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

Physical therapy

Raquel P Aguilar, PhDcand

José Antonio P Simón, PHD

Raquel P Aguilar, Ph.D.cand.

José Antonio P Simón, PhD

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.

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.

Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

Physical Therapy in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation With a Diagnosis of Chronic Graft-versus-host Disease: A Randomized Clinical Trial.

Study protocol for a randomized clinical trial.

MEASURE NAME: Functional Assessment of Cancer Therapy - Bone Marrow Transplantation (FACT-BMT); VERSION: 4; NUMBER OF ITEMS: 50; RESPONSE SCALE: 5 point Likert-type scale; SCORING:Manual scoring template, some items are reverse scored. Higher score represents better quality of life.

Modified Lee Chronic Graft-Versus-Host Disease Symptom Scale (mLSS) for 7 days. This is an instrument with 7 domains (skin, eyes, mouth, lungs, nutrition, energy, and psychiatry) and a total of 28 items to assess. The response options for "Please inform us if any of the following problems have bothered you in the last 7 days" range from 0 to 4 (Not at all, A little, Moderately, Quite a bit, Extremely). A difference of 5 to 6 points (standard deviation) will be considered clinically significant. Subscales range from 0 to 100, with a higher score indicating worse symptoms.

Sit-to- Stand test y Handrig strength test

"Mood Assessment Scale" (MAS); Designed to assess transient mood states, both positive and negative, in any individual at any time, through 16 items divided into four scales (depression, anxiety, hostility, and joy), each defined by 4 items and evaluated using the Likert scale, with scores ranging from 0 to 10. The values for each category are calculated by the mean. All 16 statements have the same structure; they all begin with the phrase "I feel" and end with an adjective describing a mood state.

Hospital Anxiety and Depression Scale (HADS) questionnaire; The "Hospital Anxiety and Depression Scale questionnaire" (HADS); a useful tool for identifying anxiety and depression states in cancer patients and applicable during clinical practice. The two categories consist of one subscale each, with seven items rated from 0 to 4 points, with higher scores (in the range of 0 to 21) indicating anxious and depressive states. Participants should respond considering how they felt and/or behaved during the last seven days.

Cytokines (interleukins) and lymphocytic populations as part of routine analysis. Blood sample.

Spots Global Cancer Trial Database for graft versus host disease, chronic