Benefits of Intrahospital Exercise Program in Pediatric HSCT

Not Applicable

Completed

• Conditions: Hematopoietic Stem Cell Transplant; Pediatric Cancer; Deconditioning

• Registration Number: NCT06692478
• Lead Sponsor: Phoenix Children's Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-01
• Study First Submitted: 2017-11-02
• Primary Completion: 2019-08-01
• Study Completion: 2019-10-01
• Status Verified: 2024-04
• Study First Submitted QC: 2024-11-14
• Last Update Submitted: 2024-11-14
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

1. Patients ages 4-21 years of age who present for hematopoietic stem cell transplant.
2. Karnofsky (if ≥16 years) or Lansky (if <16 years) score >60 at enrollment and prior to each testing point
3. Parental/guardian permission (informed consent) and child assent prior to transplant.

Exclusion Criteria

1. Patients with any preexisting need for gait assistance such as crutches, wheelchair, braces, or walker
2. Previous stem cell transplant in the last 6 months
3. Patients with grade 3 or greater sensory/motor neuropathy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Change from Baseline 6-minute walk test at 6 weeks discharge.	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	Average of 100 days post-transplant	Muscle strength
WeeFIM	Average of 100 days post-transplant	Change from Baseline Functionality at 6 weeks post discharge.

Secondary Outcome Measures

Name	Time	Method
PROMISE Measures	Average of 100 days post transplant	Change from Quality of Life measurements based off of physical, mental, and social categories at 6 weeks post discharge
Time Out of Bed	through study completion, average of 1 year	Log of average time out of bed for each patient.

Trial Locations

Locations (1)

Phoenix Children's Hospital; 🇺🇸 Phoenix, Arizona, United States