Virtual Rehabilitation in HCT

NCT05943964 | Recruiting DMC

• 1 other identifier: STUDY00005995
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Cell Transplant

Keywords

Virtual Rehabilitation; Virtual Exercise; Physical fitness

Outcome Measures

Primary Outcomes (2)

• Adherence Rate

  Percentage of sessions completed per participant. A log will be kept to track the sessions completed by participants during the study participation

  Throughout the intervention (up to 16 weeks)

• Feasibility of the rehabilitation program

  Percentage of patients completing ≥75% of sessions

  Up to 4 years

Secondary Outcomes (1)

• Change in 6-minute walk test at completion of the rehabilitation program

  Baseline and up to 16 weeks

Study Arms (1)

Virtual exercise and rehabilitation program

EXPERIMENTAL

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

Behavioral: Virtual exercise and rehabilitation program

Interventions

Virtual exercise and rehabilitation program 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.

Also known as: Virtual Rehabilitation in HCT

Virtual exercise and rehabilitation program

Eligibility Criteria

• Age: 8 Years - 23 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Emory University: lead
• Incyte Corporation: collaborator

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

RECRUITING

MeSH Terms

Interventions

Rehabilitation; Telerehabilitation; Hematocrit

Intervention Hierarchy (Ancestors)

Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services; Telemedicine; Delivery of Health Care; Patient Care Management; Health Services Administration; Hematologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Hemorheology; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Muna Qayed, MD, MsCR

  Emory University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Muna Qayed, MD, MsCR

CONTACT

(404) 785-1112; mqayed@emory.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: July 5, 2023
• First Posted: July 13, 2023
• Study Start: July 31, 2023
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: September 19, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)