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Completed

NCT Number: NCT06692478

Benefits of Intrahospital Exercise Program in Pediatric HSCT

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.

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Key information

Conditions

Hematopoietic Stem Cell Transplant Deconditioning Neoplasms Pediatric Cancer

Age range

4 year–21 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exercise regimen

Behavioral

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.

Primary outcomes

  1. 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.)

  2. Change from Baseline Manual Muscle Testing at 6 weeks post discharge

    Time frame: Average of 100 days post-transplant

    Muscle strength

  3. WeeFIM

    Time frame: Average of 100 days post-transplant

    Change from Baseline Functionality at 6 weeks post discharge.

Secondary outcomes

  1. PROMISE Measures

    Time frame: 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

  2. Time Out of Bed

    Time frame: through study completion, average of 1 year

    Log of average time out of bed for each patient.

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Collaborators

  • University of Arizona

Registry information

Official study title

Benefits of Intrahospital Exercise Program in Pediatric Hematopoietic Stem Cell Transplant-A Randomized Control Trial

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Nov 18, 2024
Registry last updated
Nov 18, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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