Exercise in Pediatric Autologous Stem Cell Transplant Patients
NCT ID: NCT01666015
Last Updated: 2016-10-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
NA
24 participants
INTERVENTIONAL
2012-06-30
2014-10-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exercise (EX)
This group will perform two phases of an EX program.
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).
Standard Care
This group will follow the standard care without any EX prescription.
Standard Care
This group will be under standard care without any EX intervention.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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).
Standard Care
This group will be under standard care without any EX intervention.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
5 Years
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Alberta Children's Hospital
OTHER
University of Calgary
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr. Nicole Culos-Reed
Ph.D, Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nicole S Culos-Reed, Ph.D
Role: PRINCIPAL_INVESTIGATOR
University of Calgary Faculty of Kinesiology, Faculty of Medicine and Department of Psychosocial Resources, Tom Baker Cancer Centre
Carolina Chamorro-Viña, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Faculty of Kinesiology, University of Calgary.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
University of Calgary
Calgary, Alberta, Canada
Alberta Children's Hospital
Calgary, Alberta, Canada
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
Chamorro-Vina C, Guilcher GM, Khan FM, Mazil K, Schulte F, Wurz A, Williamson T, Reimer RA, Culos-Reed SN. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol. BMC Cancer. 2012 Sep 10;12:401. doi: 10.1186/1471-2407-12-401.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
University of Calgary
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
RF-CACICPES01
Identifier Type: -
Identifier Source: org_study_id