Hematopoietic Cell TransplantNCT05943964
Virtual Rehabilitation in HCT
A study testing Virtual exercise and rehabilitation program in people with Hematopoietic Cell Transplant, run by Emory University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 23 years
- Conditions the study is for
- Hematopoietic Cell Transplant
- What is being tested?
- Virtual exercise and rehabilitation program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jul 2023to 7 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 23 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
United States1 site
Children's Healthcare of Atlanta
Atlanta, Georgia, 30322
About this study
Official title: A Pilot Study of Virtual Rehabilitation After Hematopoietic Cell Transplantation
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.
Read the 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
- Being tested
- Virtual exercise and rehabilitation program
- Keywords
- Virtual Rehabilitation, Virtual Exercise, Physical fitness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual exercise and rehabilitation programBehavioural
Also called Virtual Rehabilitation in HCT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Virtual exercise and rehabilitation program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence Rate
Percentage of sessions completed per participant. A log will be kept to track the sessions completed by participants during the study participation
Measured: Throughout the intervention (up to 16 weeks)
Feasibility of the rehabilitation program
Percentage of patients completing ≥75% of sessions
Measured: 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
Measured: Baseline and up to 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start31 Jul 2023
- Primary completion7 Jul 2026
- Study completion7 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematopoietic Cell TransplantStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Collaborators
- Incyte Corporation
- Responsible party
- Principal investigator, Muna Qayed, Emory University
- Investigators
- Muna Qayed, MD, MsCR, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943964
- Sponsor's protocol ID
- STUDY00005995
- Other IDs
- 2025P010748
- Status last verified
- Sep 2026
- First submitted
- 5 Jul 2023
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of Virtual Rehabilitation After Hematopoietic Cell Transplantation
- ClinicalTrials.gov ID
- NCT05943964
- Acronym / sponsor ID
- STUDY00005995
- Conditions
- Hematopoietic Cell Transplant
- Keywords
- Virtual Rehabilitation, Virtual Exercise, Physical fitness
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Collaborators
- Incyte Corporation
- Study start
- 31 Jul 2023 (actual)
- Primary completion
- 7 Jul 2026 (actual)
- Study completion
- 7 Jul 2026 (actual)
- First posted
- 13 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Virtual exercise and rehabilitation program | Experimental | Behavioral: Virtual exercise and rehabilitation programTrial of exercise and rehabilitation program delivered via a virtual platform for patients undergoing HCT at Children's Healthcare of Atlanta. |
Who may qualify
- Ages
- 8 to 23 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual exercise and rehabilitation programAlso: Virtual Rehabilitation in HCTParticipants 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. | Behavioural | Virtual exercise and rehabilitation program |
Primary outcome
Adherence Rate
Time frame: Throughout the intervention (up to 16 weeks)
Percentage of sessions completed per participant. A log will be kept to track the sessions completed by participants during the study participation
Feasibility of the rehabilitation program
Time frame: Up to 4 years
Percentage of patients completing ≥75% of sessions
1 secondary outcome
Change in 6-minute walk test at completion of the rehabilitation program
Time frame: Baseline and up to 16 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muna Qayed, MD, MsCR principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual exercise and rehabilitation program in people with Hematopoietic Cell Transplant, run by Emory University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adherence Rate (time frame: Throughout the intervention (up to 16 weeks)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.