NCT06692478
Completed
Not Applicable
Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hematopoietic Stem Cell Transplant
- Sponsor
- Phoenix Children's Hospital
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Change from Baseline 6-minute walk test at 6 weeks discharge.
- Status
- Completed
- Last Updated
- last year
Overview
Brief Summary
This randomized control study examines the effect of an intrahospital exercise regimen on the physical deconditioning that occurs due to hematopoietic stem cell transplant in the pediatric population.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
- •Karnofsky (if ≥16 years) or Lansky (if \<16 years) score \>60 at enrollment and prior to each testing point
- •Parental/guardian permission (informed consent) and child assent prior to transplant.
Exclusion Criteria
- •Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
- •Previous stem cell transplant in the last 6 months
- •Patients with grade 3 or greater sensory/motor neuropathy
Outcomes
Primary Outcomes
Change from Baseline 6-minute walk test at 6 weeks discharge.
Time Frame: Average of 100 days post-transplant
Test of Endurance (Pre-transplant, at discharge, and 6 weeks discharge.)
Change from Baseline Manual Muscle Testing at 6 weeks post discharge
Time Frame: Average of 100 days post-transplant
Muscle strength
WeeFIM
Time Frame: Average of 100 days post-transplant
Change from Baseline Functionality at 6 weeks post discharge.
Secondary Outcomes
- PROMISE Measures(Average of 100 days post transplant)
- Time Out of Bed(through study completion, average of 1 year)
Study Sites (1)
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