Recruiting

Virtual Rehabilitation

Sponsor:

Emory University

Code:

NCT05943964

Conditions

Hematopoietic Cell Transplant

Eligibility Criteria

Sex: All

Age: 8 - 23

Healthy Volunteers: Not accepted

Interventions

Virtual exercise and rehabilitation program

Study Details

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

Study ID

NCT05943964

Start date

Jul 31, 2023

Status verified date

Sep, 2025

Completion date

Aug, 2027

Anticipated

Primary completion date

Aug, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 8 - 23

Healthy Volunteers: Not accepted

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).

Study Design

Enrollment

40 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

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.

Primary outcome measure

  • Adherence Rate [ Time Frame: Throughout the intervention (up to 16 weeks) ]
  • Feasibility of the rehabilitation program [ Time Frame: Up to 4 years ]

Central Contacts and Locations

Central contacts

Locations

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30322

Contacts

More Information

Sponsor

Emory University

Last update posted

Sep 19, 2025

Last verified

Sep, 2025

Keywords

  • Virtual Rehabilitation
  • Virtual Exercise
  • Physical fitness

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Emory University on 2025-09-19.