Exercise in Pediatric Autologous Stem Cell Transplant Patients (SCORE)

October 24, 2016 updated by: Dr. Nicole Culos-Reed, University of Calgary

Exercise in Pediatric Autologous Stem Cell Transplant Patients: A Randomized Controlled Trial Protocol

Hematopoietic stem cell transplantation is an intensive therapy used to improve survivorship and cure various oncologic diseases. However, this therapy is associated with high mortality rates and numerous negative side-effects. The recovery of the immune system is a special concern and plays a key role in the success of this treatment. In healthy populations it is known that exercise plays an important role in immune system regulation, but little is known about the role of exercise in the hematological and immunological recovery of children undergoing hematopoietic stem cell transplant. The Primary objective of this Randomized Controlled Trial is: study the effect of an exercise program on immune cell recovery in patients undergoing autologous stem cell transplantation. The Secondary objective is to determine if an exercise intervention might diminish the deterioration of quality of life, physical fitness, and the acquisition of a sedentary lifestyle.

Methods

Twenty-four participants treated for a malignancy with autologous stem cell transplant (5 to 18 years) in the Alberta Children's Hospital will be randomly assigned to an exercise or control group. The exercise group will participate in a two-phase exercise intervention (in and outpatient) from hospitalization until 10 weeks after discharge. The exercise program includes strength, flexibility and aerobic exercise. During the inpatient phase this program will be performed 5 times/week and will be supervised. The outpatient phase will combine a supervised session with two home-based exercise sessions with the use of the Wii device. The control group will follow the standard protocol without any specific exercise program. A range of outcomes, including quantitative and functional recovery of immune system, cytokine levels in serum, NK cells and their subset recovery and function, and gene expression of activating and inhibitory NK cell receptors, body composition, nutrition, quality of life, fatigue, health-related fitness assessment and physical activity levels will be examined, providing the most comprehensive assessment to date.

Discussion We expect to find an improvement in the immunological recovery, quality of life, decreased acquisition of sedentary behavior and less fitness deconditioning.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
        • Alberta Children's Hospital
      • Calgary, Alberta, Canada, T2N 1N4
        • University of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • autologous SCT at Alberta Children's Hospital (ACH) for malignancy
  • age 5 to 18 years of age
  • will be receiving myeloablative conditioning regimen
  • no evidence of cardiac or pulmonary failure associated with treatment (SF≥28%, EF ≥ 50%)
  • no functional nor cognitive limitation that would prohibit performance of the home-based training
  • approval by treating oncologist for participants
  • a parent or legal guardian must sign the consent form and
  • children should express verbal assent to participate.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Exercise (EX)
This group will perform two phases of an EX program.
Other: EXERCISE (EX)

This study will examine the effect of two phases of an EX program on several health related outcomes in pediatric patient undergoing autologous SCT. The first phase of the EX program will be an inpatient intervention and will begin when the child is hospitalized undergoing conditioning therapy and will continue until discharge.

The second phase will be a 10-week outpatient intervention, beginning once the child is discharged. We will utilize a mixed EX program, including supervised (at the University of Calgary) and home-based training incorporating the use of the Nintendo ® Wii device™ (Wii Fit, Wii Dance and Sports™ games).

Other Names:
  • PHYSICAL ACTIVITY
Active Comparator: Standard Care
This group will follow the standard care without any EX prescription.
Other: Standard Care
This group will be under standard care without any EX intervention.
Other Names:
  • Active comparator/ control

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hematological and Immunological Recovery
Time Frame: This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)
Assessment of the impact of the Exercise (EX) intervention on the immune recovery of pediatric autologous SCT patients will be based on four parameters (a) Recovery of different leukocyte cell subset (e.g., T cells, Natural killer cells, B cells, monocytes, neutrophils etc) in peripheral blood by flow cytometry, (b) Expression of activating and inhibitory Killer IRs by Gene expression analysis of 14 KIR genes will be done by RNA based real-time PCR analysis(c) Function of NK cells and their subsets by measuring in-vitro cytokine secretion and degranulation by different NK cell subsets (cytolytic and regulatory NK cells) on incubation with K-562 cell lines and (d) Levels of different pro-inflammatory and regulatory cytokines in serum using a bead-based array on Luminex.
This assessments will be performed at baseline, 7, 14, 28, 56, 84 and 180 days after stem cell transplantation (SCT)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of life (QOL)
Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
Will be assessed using the Pediatric quality of life inventory (PedsQL) general and cancer module as a self-report, and PedsQL and Behavior Assessment System for Children (BASC-2) as parent proxy report. Fatigue will be assessed using the multidimensional PedsQL fatigue scale.
Assessment will be completed at baseline, 30, 90 and 180 days after SCT

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related fitness assessment
Time Frame: Assessment will be completed at baseline, 30 and 90 days after SCT

Body composition; musculoskeletal fitness (flexibility, muscular strength and endurance); functional mobility and cardiorespiratory fitness will be performed.

Body composition: weight, height, skinfold measure (biceps, triceps, subscapular and suprailiac).

Flexibility: sit and reach Muscular strength: A hand- held dynamometer will be used to assess grip strength and knee extension.

Muscular endurance: modified push up, partial curl-up and 30 seconds squat test.

Functional mobility: Time up and go test (3 meters) Cardiorespiratory fitness: Treadmill submaximal test. Height and tanner stage will be used to determine duration of each stage (2-3 minutes) and initial velocity of the protocol.
Assessment will be completed at baseline, 30 and 90 days after SCT
Physical activity levels
Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
A triaxial accelerometer (Actical - Phillips respironic) will be put on when the participant gets up from bed each day and worn until the participant is ready to fall asleep. Subjects can go about their normal, daily activities, including rigorous exercise, swimming or bathing. During each assessment subjects will be instructed to wear the activity monitor over their right hip on an elasticized belt for seven consecutive days. Additionally, participants will be asked to record, in a daily log, the time they put on and took off the monitor each day.
Assessment will be completed at baseline, 30, 90 and 180 days after SCT
Demographic and health assessment
Time Frame: This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT
Demographic characteristics, health record information (type of cancer, disease status, co-morbid conditions, cancer treatment received, side-effects of treatment) and information related to SCT (platelet and neutrophil engraftment, conditioning regimen received, toxicities due to conditioning regimen, documented infection, incidence of fever) will be collected. A questionnaires will be filled out by the physician.
This assessment will be perfomed at baseline, 15, 30, 60, 90 days after SCT
Dietary intake
Time Frame: Assessment will be completed at baseline, 30, 90 and 180 days after SCT
Usual dietary intake will be assessed using a 3-day dietary record. Dietary records will be analyzed by a Registered Dietitian using Diet Analysis Plus 10.0 software (Thomson Wadsworth, Toronto, Canada.
Assessment will be completed at baseline, 30, 90 and 180 days after SCT

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Alberta Children's Hospital

Investigators

  • Principal Investigator: Nicole S Culos-Reed, Ph.D, University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre
  • Principal Investigator: Carolina Chamorro-Viña, Ph.D, Faculty of Kinesiology, University of Calgary.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

August 1, 2014

Study Completion (Actual)

October 1, 2014

Study Registration Dates

First Submitted

August 10, 2012

First Submitted That Met QC Criteria

August 15, 2012

First Posted (Estimate)

August 16, 2012

Study Record Updates

Last Update Posted (Estimate)

October 26, 2016

Last Update Submitted That Met QC Criteria

October 24, 2016

Last Verified

October 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RF-CACICPES01
  • University of Calgary (Other Grant/Funding Number: RSO1020497)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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