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Benefits of Exercise Program in Pediatric HSCT

NCT04663503 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2022-02-01

No results posted yet for this study

Summary

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".

Conditions

  • Exercise
  • Transplantation

Interventions

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

Sponsors & Collaborators

  • Phoenix Children's Hospital

    lead OTHER

Principal Investigators

  • Alexander Ngwube, MD · Phoenix Children's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-11
Primary Completion
2021-04-12
Completion
2021-04-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04663503 on ClinicalTrials.gov