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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04663503
Other study ID # IRB-16-127
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 11, 2019
Est. completion date April 12, 2021

Study information

Verified date January 2022
Source Phoenix Children's Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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".


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.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date April 12, 2021
Est. primary completion date April 12, 2021
Accepts healthy volunteers No
Gender All
Age group 4 Years to 21 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States Phoenix Children's Hospital Phoenix Arizona

Sponsors (1)

Lead Sponsor Collaborator
Phoenix Children's Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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.
Primary 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 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.
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