Virtual Rehabilitation in HCT

NCT ID: NCT05943964

Last Updated: 2025-09-19

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-31
• Study Completion Date: 2027-08-31

Brief Summary

Chronic GVHD (cGVHD) is a major cause of illness in patients who undergo hematopoietic transplantation (HCT). GVHD can affect any organ in the body, can require several years of treatment, and can impact the quality of life (QoL). Physical activity and exercise have been shown to enhance fitness and improve QoL in chronic illnesses including GVHD, however, patients often have barriers to attending sessions including distance, risk of infection, and physical therapists' lack of experience with pediatric patients. The team's goal is to assess whether a virtual rehabilitation program in children post-HCT (including children with chronic GVHD) is feasible and whether its implementation will improve physical functioning and QoL. Patients between the ages of 8 and 23 years who are at least one hundred days post-HCT will be eligible for participation. Patients will have an assessment by a pediatric physical therapist at the time of study entry, at the end of the rehabilitation program, and approximately 3 months later. They will be supplied with some exercise equipment (such as dumbbells and resistance bands). Patients will have twice weekly half-hour one-on-one online sessions with the physical therapist for 12 weeks. Patients will be recruited through the bone marrow transplant clinic.

Detailed Description

Physical rehabilitation is an important, but often inadequately addressed, component of comprehensive cGVHD care. Physical activity and exercise have been shown to enhance fitness and improve QoL, including in patients with chronic diseases. Studies in patients undergoing HCT (including patients with GVHD) show the positive impact of exercise on QoL including improved endurance, muscular strength, functional capacity, perceptions of fatigue, and emotional, and social well-being. Evidence supports that the most effective intervention is supervised participation, followed by self-administered exercise programs and that these interventions are safe and well-tolerated. While rehabilitation is often specifically recommended to cGVHD patients, barriers include the ability to travel, and the time and distance from the rehabilitation center. This is especially relevant in pediatrics, where fewer centers offer services to children. Additionally, parents and providers often express concerns about infection risk as a strong barrier to pursuing rehabilitation. The use of a virtual platform overcomes these limitations.

Virtual cardiac rehabilitation programs are a novel concept designed to improve accessibility and adherence. These have been shown to be beneficial in some studies post-cardiac transplantation. Investigators propose a virtual program that incorporates exercise and stretching for children with cGVHD. If successful, this could be a guide for institutions to adopt and could help improve the landscape of rehabilitation in pediatric and adult patients with cGVHD. Further, patients early post-HCT often benefit from rehabilitation services, however, these services are often limited by the extensive outpatient visit schedule, acute illness, and concern regarding isolation and severely immunocompromised state. If feasible, this virtual program could be extended to patients post-HCT without cGVHD and is likely to improve daily function and QoL.

Conditions

Hematopoietic Cell Transplant

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Virtual exercise and rehabilitation program

Trial of exercise and rehabilitation program delivered via a virtual platform for patients undergoing HCT at Children's Healthcare of Atlanta.

Group Type: EXPERIMENTAL

Virtual exercise and rehabilitation program

Intervention Type: BEHAVIORAL

Participants will have two 30-minute sessions per week for 12 weeks. The program will focus on aerobic exercises and stretching exercises. When applicable, stretching exercises will focus on areas of contractures, and joints with limited range of motion (ROM).

Sessions will be completed by a team of Physical Therapists using the established telemedicine platform at Children's Healthcare of Atlanta, as used routinely in the blood and marrow transplant clinic for clinical care (Epic). Adherence to the program will be encouraged during monthly standard clinic visits.

Interventions

Virtual exercise and rehabilitation program

Participants will have two 30-minute sessions per week for 12 weeks. The program will focus on aerobic exercises and stretching exercises. When applicable, stretching exercises will focus on areas of contractures, and joints with limited range of motion (ROM).

Sessions will be completed by a team of Physical Therapists using the established telemedicine platform at Children's Healthcare of Atlanta, as used routinely in the blood and marrow transplant clinic for clinical care (Epic). Adherence to the program will be encouraged during monthly standard clinic visits.

Intervention Type: BEHAVIORAL

Other Intervention Names

Virtual Rehabilitation in HCT

Eligibility Criteria

Inclusion Criteria

• Recipients between the ages of 8 and 23 years ≥100 days post allogeneic HCT.
• Patients 8-14 years old should have a caregiver willing to assist with the implementation of the exercises during the session
• Patients should have access to devices and a reliable internet connection.
• Patients should be cleared for exercise by their physician
• Patients are eligible to participate regardless of underlying diagnosis, preparative regimen, or graft source.

Exclusion Criteria

• Any physical impediment to exercise as evaluated by the treating physician.
• Non-English-speaking patients (due to a lack of available interpreters through the telemedicine platform).

• Minimum Eligible Age: 8 Years
• Maximum Eligible Age: 23 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: collaborator

Emory University

OTHER

Sponsor Role: lead

Responsible Party

Muna Qayed

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Muna Qayed, MD, MsCR

Role: PRINCIPAL_INVESTIGATOR

Emory University

Locations

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Muna Qayed, MD, MsCR

Role: CONTACT

mqayed@emory.edu

(404) 785-1112

Facility Contacts

Muna Qayed

Role: primary

mqayed@emory.edu

(404) 785-1112

Other Identifiers

STUDY00005995

Identifier Type: -

Identifier Source: org_study_id