Benefits of Exercise Program in Pediatric HSCT

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

Deconditioning is a common adverse effect of short and long-term immobilization. For months pediatric hematopoietic stem cell transplant patients can be quarantined while hospitalized, much of which time is spent immobilized putting these patients at a higher risk for loss of muscle strength, functionality, endurance, and quality of life. Phoenix Children's Hospital is conducting approximately forty (40) transplants per year. Adult studies have shown that exercise as an effective counter measure to deconditioning in stem cell transplant patients. However, there is a knowledge gap in pediatric HSCT. Thus this study is being conducted to determine if there is a correlation between intra-hospital exercise and improved functionality, mobility, strength, and quality of life. To achieve these aims investigators will perform a randomized control study. The investigators will aim to recruit 40 patients, 20 in each arm, ages 4-21 at Phoenix Children's Hospital. Each participant will receive baseline measures by a physical therapist; for functionality using (WeeFIM), muscle strength using manual muscle testing (MMT), endurance using the 6-minute walk test, and quality of life using the NIH PROMIS measures. Measurements will be taken again at discharge and 6-weeks post-discharge. During hospital admittance the intervention group will perform exercise routines 3 times weekly while the control group will be treated per standard of care with no exercise intervention. Patients recruited must be receiving first HSCT. A full explanation of the study and possible benefits will be given to the patients and their families upon consent. Primary outcomes will look at endurance, functionality and muscle strength. Secondary outcomes will include QoL and amount of achievable "time out of bed".

Study Overview

• Status: Completed
• Conditions: Exercise; Transplantation
• Intervention / Treatment: Other: Exercise program

Detailed Description

Despite growing numbers of publications describing the effects of these exercise modalities in adult HSCT patients, only limited attention has been paid to this effective supportive therapy in children. Only five publications describe the effectiveness of exercise training in pediatric HSCT. San Juan et al. showed beneficial effects on functional performance, muscle strength, and Qol scores in a study of children (aged 8-16) undergoing a supervised exercise program that included resistance and aerobic exercises for 3 weeks after HSCT. In another study, the moderate intensity exercise program implemented to children undergoing allogeneic HSCT for 3 weeks during hospitalization showed positive effects on body mass and body mass index (BMI), and no negative effect on immune cell recovery. It was found that a structured physical activity program has positive effects on Qol and fatigue scores in children undergoing peripheral blood stem cell transplantation. Yildez et al. showed improvement in areas such as functional performance, muscle strength, functional mobility. Marchese et al. showed an improvement in knee extension strength and ankle dorsiflexion range of motion.This study will implement an exercise program that is personalized to hematopoietic stem cell transplant recipients designed to prevent a decline in function/independence. Investigators will accomplish this by conducting a randomized controlled trial (RCT) that will examine the effect of an 8-12 week personalized exercise program compared to standard care following hematopoietic stem cell transplantation. Data from this study should increase understanding of the effect of exercise in this population on QoL, functional ability, endurance, muscle strength, and fatigue.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85016
      • Phoenix Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 21 years (ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Subjects age 4-21 years
• Admitted for Hematopoietic Stem Cell 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: SUPPORTIVE_CARE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Intervention arm -Exercise Program; This structured exercise program will incorporate a specially designed, low intensity, resistance based exercise regime created by our physical therapist. It consists of strengthening, endurance, stretching and relaxation exercises tailored according to age and their ability to perform activities throughout their hospitalization (Appendix 3). 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.	Other: Exercise program; Depending on the age, there will be two components of the exercise program completed by the patients. The first component will be strengthening exercises. The second component will be endurance activities. This will be administered by the physical therapist
NO_INTERVENTION: Control arm- 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Six minute walk test	Used in measuring exercise capacity and endurance.	Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge
Pediatric Functional Independence Measure (WeeFIM)	Used to measure functionality.	Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.
Manual muscle testing (MMT)	Useful to measure muscle strength	Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge.This would be done through study completion, an average of 12 weeks.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Outcomes Measurement Information System (PROMIS) Measures	Changes in quality of life	Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge. This would be done through study completion, an average of 12 weeks.

Collaborators and Investigators

• Sponsor: Phoenix Children's Hospital

Publications and helpful links

General Publications

• Smith C, Farhat R, Fern-Buneo A, Purrington H, Cobb E, Matson L, Kang P, Beebe K, Campbell C, Schwalbach C, Salzberg D, Miller H, Adams R, Ngwube A. Effects of an exercise program during pediatric stem cell transplantation: A randomized controlled trial. Pediatr Blood Cancer. 2022 May;69(5):e29618. doi: 10.1002/pbc.29618. Epub 2022 Feb 23.

Study record dates

Study Major Dates

• Study Start (ACTUAL): March 11, 2019
• Primary Completion (ACTUAL): April 12, 2021
• Study Completion (ACTUAL): April 12, 2021

Study Registration Dates

• First Submitted: August 26, 2020
• First Submitted That Met QC Criteria: December 6, 2020
• First Posted (ACTUAL): December 11, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 28, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: IRB-16-127

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No