Precision Exercise in Children With Malignant Hemopathies (SportTherapy)
Primary Purpose
Leukemia, Myeloid, Acute, Leukemia, B-cell, Leukemia, T Cell
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Sport Therapy
Sponsored by
About this trial
This is an interventional treatment trial for Leukemia, Myeloid, Acute focused on measuring exercise, children, adolescent, cancer, malignant hemopathies, leukemia, lymphoma, hematopoietic stem cell transplant, survivor, oxidative metabolism, strength, balance, flexibility, quality of life
Eligibility Criteria
Inclusion Criteria:
- Children with malignant hemopathies attending the Maria Letizia Verga Center
Exclusion Criteria:
- Children under 2 years
Sites / Locations
- Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her ChildRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Children with malignant hemopathies
Healthy children
Arm Description
Children with malignant hemopathies attending a precision exercise training
Healthy children
Outcomes
Primary Outcome Measures
Change from baseline oxidative metabolism at 12 weeks
Maximal O2 uptake and skeletal muscle O2 extraction
Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
1 repetition maximal
Change from baseline balance at 12 weeks
Stabilometry
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.
Secondary Outcome Measures
Change from baseline Satisfaction at 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
6 minute walking test
Change from baseline Time up and down stairs test at 12 weeks
Time up and down stairs test
Change from baseline yo yo test at 12 weeks
Shuttle incremental walking/run test
Change from baseline MOON test at 12 weeks
MOON test
Full Information
NCT ID
NCT04090268
First Posted
June 2, 2019
Last Updated
October 24, 2022
Sponsor
University of Milano Bicocca
Collaborators
Comitato Maria Letizia Verga,Italy
1. Study Identification
Unique Protocol Identification Number
NCT04090268
Brief Title
Precision Exercise in Children With Malignant Hemopathies
Acronym
SportTherapy
Official Title
Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 3, 2017 (Actual)
Primary Completion Date
April 3, 2025 (Anticipated)
Study Completion Date
April 3, 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Milano Bicocca
Collaborators
Comitato Maria Letizia Verga,Italy
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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:
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;
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);
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Leukemia, Myeloid, Acute, Leukemia, B-cell, Leukemia, T Cell, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Drepanocytosis, Thalassemia Major, Adrenoleukodystrophy
Keywords
exercise, children, adolescent, cancer, malignant hemopathies, leukemia, lymphoma, hematopoietic stem cell transplant, survivor, oxidative metabolism, strength, balance, flexibility, quality of life
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
380 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Children with malignant hemopathies
Arm Type
Experimental
Arm Description
Children with malignant hemopathies attending a precision exercise training
Arm Title
Healthy children
Arm Type
No Intervention
Arm Description
Healthy children
Intervention Type
Other
Intervention Name(s)
Sport Therapy
Other Intervention Name(s)
Precision exercise program
Intervention Description
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
Primary Outcome Measure Information:
Title
Change from baseline oxidative metabolism at 12 weeks
Description
Maximal O2 uptake and skeletal muscle O2 extraction
Time Frame
12 weeks
Title
Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
Description
1 repetition maximal
Time Frame
12 weeks
Title
Change from baseline balance at 12 weeks
Description
Stabilometry
Time Frame
12 weeks
Title
Change from baseline Quality of Life questionnaire at 12 weeks
Description
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
Secondary Outcome Measure Information:
Title
Change from baseline Satisfaction at 12 weeks
Description
Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.
Time Frame
12 weeks
Title
Change from baseline 6 minute walking test at 12 weeks
Description
6 minute walking test
Time Frame
12 weeks
Title
Change from baseline Time up and down stairs test at 12 weeks
Description
Time up and down stairs test
Time Frame
12 weeks
Title
Change from baseline yo yo test at 12 weeks
Description
Shuttle incremental walking/run test
Time Frame
12 weeks
Title
Change from baseline MOON test at 12 weeks
Description
MOON test
Time Frame
12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with malignant hemopathies attending the Maria Letizia Verga Center
Exclusion Criteria:
Children under 2 years
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Francesca Lanfranconi, MD, PhD
Phone
+39 0392336868
Email
francesca.lanfranconi@unimib.it
First Name & Middle Initial & Last Name or Official Title & Degree
Adriana Balduzzi, MD, PhD
Email
adriana.balduzzi@unimib.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrea Biondi, MD, PhD
Organizational Affiliation
University of Milano Bicocca
Official's Role
Principal Investigator
Facility Information:
Facility Name
Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child
City
Monza
State/Province
MB
ZIP/Postal Code
20900
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francesca Lanfranconi, MD, PhD
Phone
+39 0392336868
Email
francesca.lanfranconi@unimib.it
First Name & Middle Initial & Last Name & Degree
Adriana Balduzzi
Email
adriana.balduzzi@unimib.it
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols
IPD Sharing Time Frame
In July 2019 data will be shared, forever
IPD Sharing Access Criteria
Invitation of a common folder in google drive
IPD Sharing URL
https://drive.google.com/drive/u/0/folders
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Links:
URL
https://comitatomarialetiziaverga.it/care-and-therapy/sport-therapy/
Description
Sport Therapy project page
Learn more about this trial
Precision Exercise in Children With Malignant Hemopathies
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