Lymphoma, Non-Hodgkin Clinical Trial
— SportTherapyOfficial title:
Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
NCT number | NCT04090268 |
Other study ID # | 284 BIONDI |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 3, 2017 |
Est. completion date | April 3, 2026 |
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.
Status | Recruiting |
Enrollment | 380 |
Est. completion date | April 3, 2026 |
Est. primary completion date | April 3, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 18 Years |
Eligibility | Inclusion Criteria: - Children with malignant hemopathies attending the Maria Letizia Verga Center Exclusion Criteria: - Children under 2 years |
Country | Name | City | State |
---|---|---|---|
Italy | Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child | Monza | MB |
Lead Sponsor | Collaborator |
---|---|
University of Milano Bicocca | Comitato Maria Letizia Verga,Italy |
Italy,
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* Note: There are 18 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change from baseline oxidative metabolism at 12 weeks | Maximal O2 uptake and skeletal muscle O2 extraction | 12 weeks | |
Primary | Change from baseline strength of upper and lower limbs (1RM) at 12 weeks | 1 repetition maximal | 12 weeks | |
Primary | Change from baseline balance at 12 weeks | Stabilometry | 12 weeks | |
Primary | 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. | 12 weeks | |
Secondary | Change from baseline Satisfaction at 12 weeks | Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction. | 12 weeks | |
Secondary | Change from baseline 6 minute walking test at 12 weeks | 6 minute walking test | 12 weeks | |
Secondary | Change from baseline Time up and down stairs test at 12 weeks | Time up and down stairs test | 12 weeks | |
Secondary | Change from baseline yo yo test at 12 weeks | Shuttle incremental walking/run test | 12 weeks | |
Secondary | Change from baseline MOON test at 12 weeks | MOON test | 12 weeks |
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