Virtual Rehabilitation in HCT

Part of paid clinical trials in Atlanta, Georgia.

Sponsor
Emory University
Study ID
NCT05943964
Status
Recruiting
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Conditions

  • Hematopoietic Cell Transplant

Eligibility Criteria

Sex
ALL
Age
8 Years - 23 Years
Healthy Volunteers
Not accepted

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.

Study Details

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.

Key Dates

Start date
Jul 31, 2023
Status verified
Sep 2025
Primary completion
Aug 31, 2027
Completion
Aug 31, 2027

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE

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.

Primary Outcome Measure

Adherence Rate [ Time Frame: Throughout the intervention (up to 16 weeks) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Children's Healthcare of AtlantaAtlantaGeorgia30322
Muna Qayed
[email protected]
(404) 785-1112

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By research site
Children's Healthcare of Atlanta· Atlanta, GA

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