Precision Exercise in Children With Malignant Hemopathies

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Brief Title

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

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.
    


Study Type

Interventional


Primary Outcome

Change from baseline oxidative metabolism at 12 weeks

Secondary Outcome

 Change from baseline Satisfaction at 12 weeks

Condition

Leukemia, Myeloid, Acute

Intervention

Sport Therapy

Study Arms / Comparison Groups

 Children with malignant hemopathies
Description:  Children with malignant hemopathies attending a precision exercise training

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

380

Start Date

April 3, 2017

Completion Date

April 3, 2026

Primary Completion Date

April 3, 2025

Eligibility Criteria

        Inclusion Criteria:

          -  Children with malignant hemopathies attending the Maria Letizia Verga Center

        Exclusion Criteria:

          -  Children under 2 years
      

Gender

All

Ages

2 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Andrea Biondi, MD, PhD, +39 0392336868, [email protected]

Location Countries

Italy

Location Countries

Italy

Administrative Informations


NCT ID

NCT04090268

Organization ID

284 BIONDI


Responsible Party

Sponsor

Study Sponsor

University of Milano Bicocca

Collaborators

 Comitato Maria Letizia Verga,Italy

Study Sponsor

Andrea Biondi, MD, PhD, Principal Investigator, University of Milano Bicocca


Verification Date

September 2021