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Precision Exercise in Children With Malignant Hemopathies (SportTherapy)

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ClinicalTrials.gov Identifier: NCT04090268
Recruitment Status : Recruiting
First Posted : September 16, 2019
Last Update Posted : September 30, 2019
Sponsor:
Collaborator:
Comitato Maria Letizia Verga,Italy
Information provided by (Responsible Party):
University of Milano Bicocca

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.


Condition or disease Intervention/treatment Phase
Leukemia, Myeloid, Acute Leukemia, B-cell Leukemia, T Cell Lymphoma, Hodgkin Lymphoma, Non-Hodgkin Drepanocytosis Thalassemia Major Adrenoleukodystrophy Other: Sport Therapy Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 380 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Intervention Model Description: Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
Actual Study Start Date : April 3, 2017
Estimated Primary Completion Date : April 3, 2021
Estimated Study Completion Date : April 3, 2022


Arm Intervention/treatment
Experimental: Children with malignant hemopathies
Children with malignant hemopathies attending a precision exercise training
Other: Sport Therapy
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
Other Name: Precision exercise program

No Intervention: Healthy children
Healthy children



Primary Outcome Measures :
  1. Change from baseline oxidative metabolism at 12 weeks [ Time Frame: 12 weeks ]
    Maximal O2 uptake and skeletal muscle O2 extraction

  2. Change from baseline strength of upper and lower limbs (1RM) at 12 weeks [ Time Frame: 12 weeks ]
    1 repetition maximal

  3. Change from baseline balance at 12 weeks [ Time Frame: 12 weeks ]
    Stabilometry

  4. Change from baseline Quality of Life questionnaire at 12 weeks [ Time Frame: 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.


Secondary Outcome Measures :
  1. Change from baseline Satisfaction at 12 weeks [ Time Frame: 12 weeks ]
    Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.

  2. Change from baseline 6 minute walking test at 12 weeks [ Time Frame: 12 weeks ]
    6 minute walking test

  3. Change from baseline Time up and down stairs test at 12 weeks [ Time Frame: 12 weeks ]
    Time up and down stairs test

  4. Change from baseline yo yo test at 12 weeks [ Time Frame: 12 weeks ]
    Shuttle incremental walking/run test

  5. Change from baseline MOON test at 12 weeks [ Time Frame: 12 weeks ]
    MOON test



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Ages Eligible for Study:   2 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Children with malignant hemopathies attending the Maria Letizia Verga Center

Exclusion Criteria:

  • Children under 2 years

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090268


Contacts
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Contact: Francesca Lanfranconi, MD, PhD +39 0392336868 francesca.lanfranconi@unimib.it
Contact: Adriana Balduzzi, MD, PhD adriana.balduzzi@unimib.it

Locations
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Italy
Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child Recruiting
Monza, MB, Italy, 20900
Contact: Francesca Lanfranconi, MD, PhD    +39 0392336868    francesca.lanfranconi@unimib.it   
Contact: Adriana Balduzzi       adriana.balduzzi@unimib.it   
Sponsors and Collaborators
University of Milano Bicocca
Comitato Maria Letizia Verga,Italy
Investigators
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Principal Investigator: Andrea Biondi, MD, PhD University of Milano Bicocca

Additional Information:
Publications:

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Responsible Party: University of Milano Bicocca
ClinicalTrials.gov Identifier: NCT04090268     History of Changes
Other Study ID Numbers: 284 BIONDI
First Posted: September 16, 2019    Key Record Dates
Last Update Posted: September 30, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols
Supporting Materials: Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: In July 2019 data will be shared, forever
Access Criteria: Invitation of a common folder in google drive
URL: https://drive.google.com/drive/u/0/folders

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Milano Bicocca:
exercise
children
adolescent
cancer
malignant hemopathies
leukemia
lymphoma
hematopoietic stem cell transplant
survivor
oxidative metabolism
strength
balance
flexibility
quality of life
Additional relevant MeSH terms:
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Lymphoma
Leukemia
Lymphoma, Non-Hodgkin
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Leukemia, B-Cell
Hodgkin Disease
Leukemia, T-Cell
Adrenoleukodystrophy
Thalassemia
beta-Thalassemia
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn
Brain Diseases, Metabolic, Inborn
Brain Diseases, Metabolic
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Hereditary Central Nervous System Demyelinating Diseases
Leukoencephalopathies