Physical Therapy in Patients Undergoing Allo-HSCT With cGVHD

NCT06279585 | Not Yet Recruiting

• 1 other identifier: ECA GVHD
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Health-related quality of life

  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.

  Week 1, Week 6, and Week 13

• Chronic Graft-Versus-Host Disease (cGVHD) symptom burden

  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.

  Week 1, Week 6, and Week 13

Secondary Outcomes (8)

• Muscular strength

  Week 1, Week 6, and Week 13

• Cardiorespiratory fitness

  Week 1, Week 6, and Week 13

• Functional status

  Week 1, Week 6, and Week 13

• Distress

  Week 1, Week 6, and Week 13

• Mood

  Week 1, Week 6, and Week 13

Study Arms (2)

Experimental group

EXPERIMENTAL

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.

Other: Physical therapy

Control group

NO INTERVENTION

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.

Interventions

Physical therapy OTHER

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

Experimental group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Seville: lead

Study Sites (1)

University of Seville; Manuel Siurot Avenue, no number

Seville, 41013, Spain

Location

MeSH Terms

Conditions

Graft vs Host Disease; Bronchiolitis Obliterans Syndrome; Hematologic Neoplasms; Motor Activity

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Immune System Diseases; Organizing Pneumonia; Bronchiolitis Obliterans; Bronchiolitis; Bronchitis; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Study Officials

• José Antonio P Simón, PHD

  Chief of Hematology at Virgen del Rocío University Hospital.

  STUDY DIRECTOR

Central Study Contacts

Raquel P Aguilar, PhDcand

CONTACT

955 013 260; raquelijorml@gmail.com

José Antonio P Simón, PHD

CONTACT

955 013 260; josea.perez.simon.sspa@juntadeandalucia.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: January 28, 2024
• First Posted: February 28, 2024
• Study Start: March 1, 2024
• Primary Completion: December 1, 2024
• Study Completion: September 1, 2025
• Last Updated: February 28, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: When the study concludes; estimating by the end of the year 2025
• Access Criteria: Both the study protocol and results, as well as the statistical plan, will be published in journals registered in the Journal Citation Report

Locations

ES (1)