Virtual Rehabilitation in HCT

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age8-23
SponsorEmory University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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).

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

40 Participants
are divided into 1 treatment group
Group A: Virtual exercise and rehabilitation programExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adherence Rate

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

Time frame
Throughout the intervention (up to 16 weeks)
2

Feasibility of the rehabilitation program

Percentage of patients completing ≥75% of sessions

Time frame
Up to 4 years

Secondary outcomes

1

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

The 6-Minute Walk Distance (6MWD) test measures the distance, in meters, that a patient can quickly walk on a flat, hard surface in a period of 6 minutes

Time frame
Baseline and up to 16 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Emory University

Lead sponsor

Incyte Corporation

Collaborator