Hematopoietic Stem Cell Transplant, Pediatric Cancer, Deconditioning
Conditions
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.
Interventions
BEHAVIORALExercise regimen
Age 4-6 years: Target lower extremity, core and upper extremity strengthening and activity tolerance. With supervision by the PT, the patient will walk in their room, and complete the following through play: squat, single leg stance, climb onto couch, half kneel to stand, quadruped and tall kneeling. Age 7-21 years: First component will be strengthening exercises completed in bed or on a mat while sitting or standing. Multiple levels of exercises will be available, so that the program can be tailored to each patient and to their ability to perform activities. The exercises included will focus on core, hip musculature, and upper extremity strengthening; including exercises in quadruped and prone positioning, as well as supine, sitting and standing. Thera-Band will be used to increase resistance as needed. The second component will be endurance. Since the patients will be confined to their room this will include ambulation within the room, recumbent or pedal exerciser and step ups.
Sponsors
University of Arizona
Phoenix Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Caregiver, Investigator, Outcomes Assessor)
Masking description
The physical therapist doing the evaluations, the data analyst, and primary investigator will all be masked.
Eligibility
Sex/Gender
ALL
Age
4 Years to 21 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed