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Completed

NCT Number: NCT04663503

Benefits of Exercise Program in Pediatric HSCT

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".

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Key information

Conditions

Exercise Behavior Motor Activity Transplantation

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

exercise program

Other

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

Primary outcomes

  1. Six minute walk test

    Time frame: Change from baseline at enrollment, to discharge from hospital and at 6 weeks post discharge

    Used in measuring exercise capacity and endurance.

  2. Pediatric Functional Independence Measure (WeeFIM)

    Time frame: 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.

    Used to measure functionality.

  3. Manual muscle testing (MMT)

    Time frame: 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.

    Useful to measure muscle strength

Secondary outcomes

  1. Patient Reported Outcomes Measurement Information System (PROMIS) Measures

    Time frame: 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.

    Changes in quality of life

Sponsors and collaborators

Lead sponsor

Phoenix Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 11, 2020
Registry last updated
Feb 1, 2022

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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