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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

Tracking Information
First Submitted Date  ICMJE June 2, 2019
First Posted Date  ICMJE September 16, 2019
Last Update Posted Date September 30, 2019
Actual Study Start Date  ICMJE April 3, 2017
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • Change from baseline oxidative metabolism at 12 weeks [ Time Frame: 12 weeks ]
    Maximal O2 uptake and skeletal muscle O2 extraction
  • Change from baseline strength of upper and lower limbs (1RM) at 12 weeks [ Time Frame: 12 weeks ]
    1 repetition maximal
  • Change from baseline balance at 12 weeks [ Time Frame: 12 weeks ]
    Stabilometry
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 11, 2019)
  • 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.
  • Change from baseline 6 minute walking test at 12 weeks [ Time Frame: 12 weeks ]
    6 minute walking test
  • Change from baseline Time up and down stairs test at 12 weeks [ Time Frame: 12 weeks ]
    Time up and down stairs test
  • Change from baseline yo yo test at 12 weeks [ Time Frame: 12 weeks ]
    Shuttle incremental walking/run test
  • Change from baseline MOON test at 12 weeks [ Time Frame: 12 weeks ]
    MOON test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Precision Exercise in Children With Malignant Hemopathies
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE
  • Leukemia, Myeloid, Acute
  • Leukemia, B-cell
  • Leukemia, T Cell
  • Lymphoma, Hodgkin
  • Lymphoma, Non-Hodgkin
  • Drepanocytosis
  • Thalassemia Major
  • Adrenoleukodystrophy
Intervention  ICMJE Other: Sport Therapy
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
Other Name: Precision exercise program
Study Arms  ICMJE
  • Experimental: Children with malignant hemopathies
    Children with malignant hemopathies attending a precision exercise training
    Intervention: Other: Sport Therapy
  • No Intervention: Healthy children
    Healthy children
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 11, 2019)
380
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 3, 2022
Estimated Primary Completion Date April 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children with malignant hemopathies attending the Maria Letizia Verga Center

Exclusion Criteria:

  • Children under 2 years
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Francesca Lanfranconi, MD, PhD +39 0392336868 francesca.lanfranconi@unimib.it
Contact: Adriana Balduzzi, MD, PhD adriana.balduzzi@unimib.it
Listed Location Countries  ICMJE Italy
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04090268
Other Study ID Numbers  ICMJE 284 BIONDI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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)
Supporting Materials: 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
Responsible Party University of Milano Bicocca
Study Sponsor  ICMJE University of Milano Bicocca
Collaborators  ICMJE Comitato Maria Letizia Verga,Italy
Investigators  ICMJE
Principal Investigator: Andrea Biondi, MD, PhD University of Milano Bicocca
PRS Account University of Milano Bicocca
Verification Date September 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP