Benefits of Intrahospital Exercise Program in Pediatric HSCT

NCT06692478 | Completed

• 1 other identifier: 16-127
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematopoietic Stem Cell Transplant; Pediatric Cancer; Deconditioning

Outcome Measures

Primary Outcomes (3)

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

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

  Average of 100 days post-transplant

• Change from Baseline Manual Muscle Testing at 6 weeks post discharge

  Muscle strength

  Average of 100 days post-transplant

• WeeFIM

  Change from Baseline Functionality at 6 weeks post discharge.

  Average of 100 days post-transplant

Secondary Outcomes (2)

• PROMISE Measures

  Average of 100 days post transplant

• Time Out of Bed

  through study completion, average of 1 year

Study Arms (2)

Exercise

EXPERIMENTAL

This structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. In addition to standard of care, it consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization. This exercise program will be done three times a week for 30-45 mins supervised by the same physiotherapist throughout hospitalization and will be self-administered every weekend. A home exercise program printout with the appropriate resistance exercises will be provided to the family upon discharge, with instructions on how often to complete throughout the week. Discharged children will attend one supervised exercise session per week with the physiotherapist for six weeks. The family and patient will also be provided a weekly sheet to check off the days they completed strengthening and endurance exercises.

Behavioral: Exercise regimen

Standard of Care

NO INTERVENTION

The second arm of the study involves patients following standard of care during the HSCT period in the hospital with PT evaluation and management prescribed as needed by their transplant medical team including any additional PT interventions as a result of clinical indications. No additional intervention is incorporated in this group

Interventions

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.

Exercise

Eligibility Criteria

• Age: 4 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Phoenix Children's Hospital: lead
• University of Arizona: collaborator

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The physical therapist doing the evaluations, the data analyst, and primary investigator will all be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 2, 2017
• First Posted: November 18, 2024
• Study Start: October 1, 2017
• Primary Completion: August 1, 2019
• Study Completion: October 1, 2019
• Last Updated: November 18, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)