Exercise and health counseling for children undergoing stem cell transplants
Exercise Intervention in Childhood and Adolescence Hematopoietic Stem Cell Transplantation: The Henkō Trial
This study is testing whether a program of exercise and health counseling can help children and teens undergoing stem cell transplants for cancer feel better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 4 Years to 21 Years |
| Sex | All |
| Sponsor | Universidad Europea de Madrid Academic / other |
| Locations | 1 site (Madrid, Madrid) |
| Trial ID | NCT06300515 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a physical exercise and health counseling program for children and adolescents aged 4 to 21 who are undergoing hematopoietic stem cell transplantation (HSCT) for cancer. The aim is to address the high risk of functional decline and chronic health issues that these patients face post-transplant. Participants will be recruited from three hospitals in Madrid, and the study will compare outcomes between an intervention group receiving exercise and counseling and a control group. The research seeks to establish a feasible and effective intervention to improve the quality of life for pediatric HSCT patients.
Who should consider this trial
Good fit: Ideal candidates are children and adolescents aged 4 to 21 who are undergoing HSCT for cancer and are able to provide informed consent.
Not a fit: Patients with severe comorbidities or acute conditions that contraindicate physical exercise may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could significantly enhance the physical health and quality of life for children recovering from stem cell transplants.
How similar studies have performed: While there is limited research on exercise interventions in this specific population, similar studies in other contexts have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age between 4 and 21 years. * Undergoing hematopoietic stem cell transplantation (HSCT) for cancer diagnosis in complete remission or without remission, in 3 recruiting Hospitals in Madrid * Undergoing treatment and follow-up in the same hospital. * Speaking Spanish. * Providing signed informed consent. Exclusion Criteria: * Not being able to participate in the trial according to protocol. * Comorbidity or acute condition not associated with the diagnosis and that contraindicates the practice of physical exercise, such as severe deficiencies in the locomotor, neurological, cardiovascular and pulmonary systems. * Serious or chronic medical or psychiatric condition that may increase the risk associated with participation in the trial or that may interfere with the interpretation of the results and, in the opinion of the investigator in discussion with the team, makes having such condition inappropriate for entry to this study; inability to understand the study requirements. * Not being able to attend hospital visits to perform assessment tests, nor participate in the physical exercise and health counseling program as stipulated in the protocol. Inability to understand the requirements of the study.
Where this trial is running
Madrid, Madrid
- Hospital 12 de Octubre — Madrid, Madrid, Spain (Recruiting)
Study contacts
- Study coordinator: Carmen Fiuza-Luces, PhD
- Email: cfiuza.imas12@h12o.es
- Phone: +34658961509
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.