| NCT ID | NCT05943964 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Emory University |
| Condition | Hematopoietic Cell Transplant |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2023-07-31 |
| Primary Completion | 2027-08 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2023-07-31 with a primary completion date of 2027-08.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
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).
Contact & Investigator
Muna Qayed, MD, MsCR
PRINCIPAL INVESTIGATOR
Emory University
Frequently Asked Questions
Who can join the NCT05943964 clinical trial?
This trial is open to participants of all sexes, aged 8 Years or older, up to 23 Years, studying Hematopoietic Cell Transplant. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05943964 currently recruiting?
Yes, NCT05943964 is actively recruiting participants. Contact the research team at mqayed@emory.edu for enrollment information.
Where is the NCT05943964 trial being conducted?
This trial is being conducted at Atlanta, United States.
Who is sponsoring the NCT05943964 clinical trial?
NCT05943964 is sponsored by Emory University. The principal investigator is Muna Qayed, MD, MsCR at Emory University. The trial plans to enroll 40 participants.