An interventional study of Sport Therapy in Leukemia, Myeloid, Acute, Leukemia, B-cell and Leukemia, T Cell, sponsored by University of Milano Bicocca. Recruiting at 1 site in Italy. Open to participants aged 2 Years to 18 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-01-02.
Sponsored by University of Milano Bicocca · Not applicable, Interventional, and Treatment
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.
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:
Innovative aspects of research. At the end of the research project "Sport Therapy":
3,667 studies on the registry are indexed under Leukemia, Myeloid, Acute; 816 are open to participants now.
This study's planned enrollment of 380 is above the median of 40 across 3,005 interventional studies indexed under Leukemia, Myeloid, Acute.
Browse Leukemia, Myeloid, Acute studies →University of Milano Bicocca is the lead sponsor of 126 studies on the registry; 47 are open to participants now.
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Exclusion Criteria:
Children with malignant hemopathies attending a precision exercise training
Other: Sport Therapy
Healthy children
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
Also known as: Precision exercise program
Change from baseline oxidative metabolism at 12 weeks
Maximal O2 uptake and skeletal muscle O2 extraction
Time frame: 12 weeks
Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
1 repetition maximal
Time frame: 12 weeks
Change from baseline balance at 12 weeks
Stabilometry
Time frame: 12 weeks
Change from baseline Quality of Life questionnaire at 12 weeks
The PedsQL Measurement Model is a modular approach to measuring health-related quality of life in healthy children and adolescents and those with acute and chronic health conditions. The PedsQL Measurement Model integrates seamlessly both generic core scales and disease-specific modules into one measurement system. The 23-item PedsQL Generic Core Scales were designed to measure the core dimensions of health as delineated by the World Health Organization, as well as role (school) functioning. The 4 Multidimensional Scales (physical, emotional, social, school) and 3 Summary Scores (physical health, psycho-social health and total). Each item has a score between 0 and 4, so the scale score is between 0-100. Higher scores indicate a better QoL.
Time frame: 12 weeks
Change from baseline Satisfaction at 12 weeks
Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.
Time frame: 12 weeks
Change from baseline 6 minute walking test at 12 weeks
6 minute walking test
Time frame: 12 weeks
Change from baseline Time up and down stairs test at 12 weeks
Time up and down stairs test
Time frame: 12 weeks
Change from baseline yo yo test at 12 weeks
Shuttle incremental walking/run test
Time frame: 12 weeks
Change from baseline MOON test at 12 weeks
MOON test
Time frame: 12 weeks
Plan to share: Yes — Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols
Supporting information: Statistical analysis plan, Informed consent form
Time frame: In July 2019 data will be shared, forever
Access criteria: Invitation of a common folder in google drive
Data sharing details ↗ · drive.google.com
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