Benefits of Intrahospital Exercise Program in Pediatric HSCT

Phoenix Children's Hospital40 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

TRIPLE

Enrollment

Conditions

Hematopoietic Stem Cell Transplant Pediatric Cancer Deconditioning

Interventions

Exercise regimenBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 4 YearsMax age: 21 Years

Medical Language ↔ Plain English

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

Locations (1)

Phoenix Children's Hospital

Phoenix, Arizona, United States

Outcomes

Primary Outcomes

Change from Baseline 6-minute walk test at 6 weeks discharge.

Test of Endurance (Pre-transplant, at discharge, and 6 weeks discharge.)

Time frame: Average of 100 days post-transplant

Change from Baseline Manual Muscle Testing at 6 weeks post discharge

Muscle strength

Time frame: Average of 100 days post-transplant

WeeFIM

Change from Baseline Functionality at 6 weeks post discharge.

Time frame: Average of 100 days post-transplant

Secondary Outcomes

PROMISE Measures

Change from Quality of Life measurements based off of physical, mental, and social categories at 6 weeks post discharge

Time frame: Average of 100 days post transplant

Time Out of Bed

Log of average time out of bed for each patient.

Time frame: through study completion, average of 1 year

Data from ClinicalTrials.gov

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