Actively Recruiting
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
Led by Alejandro Lucia · Updated on 2026-03-17
48
Participants Needed
1
Research Sites
143 weeks
Total Duration
On this page
Sponsors
A
Alejandro Lucia
Lead Sponsor
H
Hospital Infantil Universitario Niño Jesús, Madrid, Spain
Collaborating Sponsor
AI-Summary
What this Trial Is About
Thanks to medical advances, survival rates \>5 years in children/adolescents undergoing hematopoietic stem cell transplant (HSCT) exceed 70%. However, these patients are at high risk of suffering sequelae associated with the underlying disease and/or the HSCT itself, which negatively affects their physical capacity. These patients also tend to spend too much time inactive, which further accelerates functional decline in addition to producing fatigue and impairing quality of life. Therefore, new strategies are needed to minimize the morbidity associated with HSCT. In this effect, although physical exercise represents an interesting adjuvant treatment option for HSCT, scientific evidence in this area is still scarce. Implementation of physical exercise intervention in pediatric HSCT units is challenging due to the lack of research on the effectiveness, affordability and accessibility of this type of intervention. Therefore, establishing the effectiveness of physical exercise under controlled conditions is an important step. The investigators therefore aim to assess the impact of a physical exercise and health counseling program, compared to health counseling only (control group), in pediatric patients with cancer undergoing HSCT on muscle strength (primary outcome), and several fitness/function, clinical burden (i.e., cardiac damage, treatment toxicities, health-related quality of life, among others) and biological variables (omics, blood immune phenotype, microbiome) (secondary outcomes). The investigators will also determine to what extent the benefits of this intervention are maintained over time. Additionally, the investigators will determine the intervention implementability in a real clinical situation in 3 different pediatric HSCT units.
CONDITIONS
Official Title
Exercise and Health Counseling in Pediatric Hematopoietic Stem Cell Transplantation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 4 and 21 years
- Undergoing hematopoietic stem cell transplantation for cancer diagnosis in complete remission or without remission at one of 3 hospitals in Madrid
- Receiving treatment and follow-up at the same hospital
- Speaking Spanish
- Providing signed informed consent
You will not qualify if you...
- Unable to participate in the trial according to protocol
- Having comorbidities or acute conditions unrelated to cancer that prevent physical exercise, such as severe problems with movement, nervous system, heart, or lungs
- Serious or chronic medical or psychiatric conditions that increase risk or interfere with study results, or inability to understand study requirements
- Unable to attend hospital visits for assessments or participate in the exercise and counseling program as planned
- Inability to understand the study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Hospital 12 de Octubre
Madrid, Madrid, Spain, 28041
Actively Recruiting
Research Team
C
Carmen Fiuza-Luces, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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