Clinical trial NCT04090268: Precision Exercise in Children With Malignant Hemopathies
Official title: Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia, Myeloid, Acute
Leukemia, B-cell
Leukemia, T Cell
Lymphoma, Hodgkin
Lymphoma, Non-Hodgkin
Drepanocytosis
Thalassemia Major
Adrenoleukodystrophy
Keywords: exercise
children
adolescent
cancer
malignant hemopathies
leukemia
lymphoma
hematopoietic stem cell transplant
survivor
oxidative metabolism
strength
balance
flexibility
quality of life
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Comitato Maria Letizia Verga,Italy
First posted: 2019-09-16
Enrollment: 380
Sex: ALL
Minimum age (years): 2
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)
Primary purpose: TREATMENT

Brief summary: In the early years of life and during adolescence, physical activity is crucial for good development of motor skills. It is even more so for those children and young people who are forced to undergo anti-cancer therapies and therefore undergo long periods of hospitalization (often bedridden) and prolonged periods of physical inactivity.

The research project "Sport Therapy" was born with the aim of demonstrating that, through targeted physical activity administered by the sports physician in collaboration with the pediatrician hematologist, it is possible to facilitate the full recovery of these patients, avoiding the high risk of chronic diseases related to a sedentary lifestyle and allowing them to better reintegrate, once healed, in their community of origin (school, sport and social relations).

The research project "Sport Therapy" was born within the Maria Letizia Verga Center at the Pediatric Clinic of the University of Milan Bicocca, at the Foundation for the Mother and Her Child, San Gerardo Hospital in Monza. Every year, around 80 children and adolescents with leukemia, lymphoma or blood disorders leading to bone marrow transplantation are treated here.

Detailed description: State of the art. Today, thanks to the progress made in the early diagnosis and treatment of cancer, there are more than 300 thousand young patients in Europe who have been cured of pediatric cancer, and by 2020 there will be almost half a million . For these children and young people, having the opportunity to perform targeted physical activity during treatment plays a key role in preventing diseases due to physical inactivity, which are one of the worst and most widespread consequences for healed patients.

Children and adolescents suffering from cancer of the blood, because of the therapies to which they are subjected, suffer a progressive reduction in respiratory and cardiac capacity, as well as muscle strength. Targeted physical exercise is a possible therapeutic approach to solving their significant problems of reduced ability to perform exercise. It is possible to administer this type of therapy thanks to the synergy created by the collaboration between pediatricians, hematologists, and sports physicians.

Why is this research important? For at least three reasons:

1. the results of the "Sport Therapy" research project will launch precision training as one of the therapeutic weapons available to combat the consequences of hematological diseases in childhood;
2. by increasing the physical capacity of children and adolescents with malignant hemopathies during the phases of cancer treatment, the investigators will reduce the heavy legacy left by treatment, thus bridging the gap regarding their disadvantage towards healthy peers and ensuring their full reintegration into their communities (school, sport, social relations);
3. a standardization of the methodology for using precision exercise in hospitalized children and adolescents will facilitate the monitoring of the progress of these type of interventions at the international level and the data from the "Sport Therapy" project will allow governments and concerned bodies not to further postpone the establishment of strategies necessary to improve the health and welfare of people cured of cancer diseases.

Innovative aspects of research. At the end of the research project "Sport Therapy":

* new strategies will be available to combat cardiopulmonary and skeletal muscle damage resulting from anticancer therapies;
* it will be definitively demonstrated how, from the very beginning of the disease, physical exercise can be a therapeutic option and not just a decorative element in the critical process of caring for children and adolescents suffering from oncological blood diseases, from the beginning of the disease;
* the possibility of introducing new technical figures in the hospital context will be clear. Sports medicine physician and exercise physiologists will be part of the multidisciplinary team that connects the hospital environment to the territory;
* the future perspective, once the experimentation has been completed and the effectiveness of the precision training intervention on the psycho-physical health of children and adolescents suffering from cancer has been demonstrated, will be to make "Sport Therapy" a permanent care service during the treatment of patients of developing age.

Eligibility criteria: Inclusion Criteria:

* Children with malignant hemopathies attending the Maria Letizia Verga Center

Exclusion Criteria:

* Children under 2 years

Primary outcomes:
measure: Change from baseline oxidative metabolism at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline balance at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline Quality of Life questionnaire at 12 weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Change from baseline Satisfaction at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline 6 minute walking test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline Time up and down stairs test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline yo yo test at 12 weeks
timeFrame: 12 weeks
measure: Change from baseline MOON test at 12 weeks
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Monza
country: Italy
facility: Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child
state: MB
Study officials:
affiliation: University of Milano Bicocca
name: Andrea Biondi, MD, PhD
role: PRINCIPAL_INVESTIGATOR
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