Benefits of Exercise Program in Pediatric HSCT

NCT04663503 | Completed

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

Brief 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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (1)

• Patient Reported Outcomes Measurement Information System (PROMIS) Measures

  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.

Study Arms (2)

Intervention arm -Exercise Program

EXPERIMENTAL

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

Control arm- No intervention

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 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

Intervention arm -Exercise Program

Eligibility Criteria

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

You may qualify if:

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

Study Sites (1)

Phoenix Children's Hospital

Phoenix, Arizona, 85016, United States

Location

Related Publications (1)

• 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.

  PMID: 35195344 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Alexander Ngwube, MD

  Phoenix Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: August 26, 2020
• First Posted: December 11, 2020
• Study Start: March 11, 2019
• Primary Completion: April 12, 2021
• Study Completion: April 12, 2021
• Last Updated: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)