Precision Exercise in Children With Malignant Hemopathies

Related Clinical Trial
A Study to Evaluate Administration of SBT101 Gene Therapy in Adult Patients With Adrenomyeloneuropathy (AMN) Study to Assess PXL065 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) Study to Assess PXL770 in Subjects With Adrenomyeloneuropathy (AMN) Form of X-linked Adrenoleukodystrophy (X-ALD or ALD) Study of Disease Progression in Adults With Inherited Forms of Spastic Paraplegia Treating Leg Symptoms in Women With X-linked Adrenoleukodystrophy Modeling Macrophages Activation Pattern in X-linked Adrenoleukodystrophy and Metachromatic Leukodystrophy SMART-ALD – A New Lifestyle Intervention to Improve Quality of Life in Women With X-linked Adrenoleukodystrophy (X-ALD) Quality of Life in Women With X-linked Adrenoleukodystrophy A Clinical Study in Male Pediatric Patients With Cerebral X-linked Adrenoleukodystrophy (Cald) to Assess the Effects of MIN-102 Treatment on Disease Progression Prior to Human Stem Cell Transplant (HSCT) Plasma Exchange With Albumin in AMN Patients Stem Cell Transplant for Inborn Errors of Metabolism Human Placental-Derived Stem Cell Transplantation Precision Exercise in Children With Malignant Hemopathies Allogeneic Bone Marrow Transplant for Inherited Metabolic Disorders Safety, Pharmacokinetics and Pharmacodynamics of NV1205 in Pediatric Male Subjects With Adrenoleukodystrophy Effect of Pioglitazone Administered to Patients With Adrenomyeloneuropathy MD1003-AMN MD1003 in Adrenomyeloneuropathy A Clinical Study to Evaluate the Efficacy and Safety of MIN-102 (IMP) in Male AMN Patients. Observational Study to Evaluate Allogeneic HSCT Outcomes for Cerebral Adrenoleukodystrophy (CALD) A Clinical Trial for AMN: Validation of Biomarkers of Oxidative Stress, Efficacy and Safety of a Mixture of Antioxidants Autologous Hematopoietic Stem Cell Gene Therapy for Metachromatic Leukodystrophy and Adrenoleukodystrophy Repetitive Transcranial Magnetic Stimulation as Therapy in Hereditary Spastic Paraplegia and Adrenomyeloneuropathy Clinical Study and Gene Mutation Analysis of Adrenoleukodystrophy in Taiwanese Children Early Diagnosis Of Childhood Cerebral ALD Randomized Study of Beta Interferon and Thalidomide in Patients With Adrenoleukodystrophy Multi-center Clinical Study on the Diagnosis and Treatment Management of Rare Neurological Disease in Children HSCT for High Risk Inherited Inborn Errors Longitudinal Natural History Study of Patients With Peroxisome Biogenesis Disorders (PBD) UCB Transplant of Inherited Metabolic Diseases With Administration of Intrathecal UCB Derived Oligodendrocyte-Like Cells Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation Haploidentical Allogeneic Hematopoietic Stem Cell Transplantation (HaploHCT) Following Reduced Intensity Conditioning (RIC) for Selected High Risk Non-Malignant Diseases The Effect of Bezafibrate on the Level of Very Long Chain Fatty Acids (VLCFA) in X-linked Adrenoleukodystrophy (X-ALD) A Phase III Trial of Lorenzo’s Oil in Adrenomyeloneuropathy Lentiviral Gene Therapy for X-ALD MT2014-14 IT-MSC for Advanced Cerebral Adrenoleukodystrophy (cALD) Safety and Pharmacodynamic Study of Sobetirome in X-Linked Adrenoleukodystrophy (X-ALD) Newborn Screening for Adrenoleukodystrophy A Study to Prospectively Assess Disease Progression in Male Children With X-ALD Long-term Follow-up of Subjects With Cerebral Adrenoleukodystrophy Who Were Treated With Lenti-D Drug Product Exercise Study of Function and Pathology for Women With X-linked Adrenoleukodystrophy Expanded Access for Lorenzo’s Oil (GTO/GTE) in Adrenoleukodystrophy Minnesota Adrenoleukodystrophy Registry Study (MARS) and Biobank A Pilot Study of Vitamin D in Boys With X-linked Adrenoleukodystrophy Effect of Glycerol Trierucate on Clinical Course of Adrenoleukodystrophy

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

      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

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

      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

Study Type


Primary Outcome

Change from baseline oxidative metabolism at 12 weeks

Secondary Outcome

 Change from baseline Satisfaction at 12 weeks


Leukemia, Myeloid, Acute


Sport Therapy

Study Arms / Comparison Groups

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


* 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


Estimated Enrollment


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




2 Years - 18 Years

Accepts Healthy Volunteers

Accepts Healthy Volunteers


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

Location Countries


Location Countries


Administrative Informations



Organization ID


Responsible Party


Study Sponsor

University of Milano Bicocca


 Comitato Maria Letizia Verga,Italy

Study Sponsor

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

Verification Date

September 2021