Actively Recruiting

Phase Not Applicable
Age: 4Years - 21Years
All Genders
NCT06300515

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

Age: 4Years - 21Years
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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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Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Hospital 12 de Octubre

Madrid, Madrid, Spain, 28041

Actively Recruiting

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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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