Leukemia, Myeloid, AcuteSportTherapyNCT04090268
Precision Exercise in Children With Malignant Hemopathies
A study testing Sport Therapy in people with Leukemia, Myeloid, Acute and Leukemia, B-cell, run by University of Milano Bicocca at 1 site in Italy.
Trial 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… Read more about this study
- Who is it for?
- Ages 2 to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Leukemia, Myeloid, Acute, Leukemia, B-cell, Leukemia, T Cell
- What is being tested?
- Sport Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteItaly
- Study dates
- 3 Apr 2017to 3 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Children with malignant hemopathies attending the Maria Letizia Verga Center
Who cannot join
- Children under 2 years
Trial locations and contacts
1 site in 1 country.
Adriana Balduzzi, MD, PhD contact
Italy1 site, 1 recruiting
- Recruiting
Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child
Monza, MB, 20900
Francesca Lanfranconi, MD, PhD, +39 0392336868, francesca.lanfranconi@unimib.it
Adriana Balduzzi, adriana.balduzzi@unimib.it
About this study
Official title: Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
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.
Read the 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.
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, B-cell, Leukemia, T Cell, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Drepanocytosis
- Being tested
- Sport Therapy
- Keywords
- exercise, children, adolescent, cancer, malignant hemopathies, leukemia, lymphoma, hematopoietic stem cell transplant, survivor, oxidative metabolism, strength, balance, flexibility, quality of life
- Medical subject headings
- Leukemia, Myeloid, Acute, Leukemia, B-Cell, Leukemia, T-Cell, Hodgkin Disease, Lymphoma, Non-Hodgkin, Sickle Cell Trait, beta-Thalassemia, Adrenoleukodystrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sport TherapyOther
Also called Precision exercise program
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training
| Study group | Role | What they receive |
|---|---|---|
| Children with malignant hemopathies | Experimental | Children with malignant hemopathies attending a precision exercise training Receives: Other: Sport Therapy |
| Healthy children | No intervention | Healthy children |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline oxidative metabolism at 12 weeks
Maximal O2 uptake and skeletal muscle O2 extraction
Measured: 12 weeks
Change from baseline strength of upper and lower limbs (1RM) at 12 weeks
1 repetition maximal
Measured: 12 weeks
Change from baseline balance at 12 weeks
Stabilometry
Measured: 12 weeks
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.
Measured: 12 weeks
Secondary outcomes (5)
Change from baseline Satisfaction at 12 weeks
Visual analog scale (VAS), from 0 to 10, where 0 is any satisfaction and 10 maximal satisfaction.
Measured: 12 weeks
Change from baseline 6 minute walking test at 12 weeks
6 minute walking test
Measured: 12 weeks
Change from baseline Time up and down stairs test at 12 weeks
Time up and down stairs test
Measured: 12 weeks
Change from baseline yo yo test at 12 weeks
Shuttle incremental walking/run test
Measured: 12 weeks
Change from baseline MOON test at 12 weeks
MOON test
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2019
- Study start3 Apr 2017
- Primary completion3 Apr 2025 (estimated)
- Study completion3 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (18)Papers the sponsor has linked to this study.
- Other trials for Leukemia, Myeloid, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)
- Masking
- None (open label)
- Enrolment
- 380 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Milano Bicocca
- Sponsor type
- University, hospital or other
- Collaborators
- Comitato Maria Letizia Verga,Italy
- Responsible party
- Sponsor
- Investigators
- Andrea Biondi, MD, PhD, Principal investigator, University of Milano Bicocca
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04090268
- Sponsor's protocol ID
- 284 BIONDI
- Acronym
- SportTherapy
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2019
- Last updated
- 2 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols
Publications
Lanfranconi F, Pollastri L, Ferri A, Fraschini D, Masera G, Miserocchi G. Near infrared spectroscopy (NIRS) as a new non-invasive tool to detect oxidative skeletal muscle impairment in children survived to acute lymphoblastic leukaemia. PLoS One. 2014 Jun 23;9(6):e99282. doi: 10.1371/journal.pone.0099282. eCollection 2014.
PubMed 24956391Arico M, Valsecchi MG, Rizzari C, Barisone E, Biondi A, Casale F, Locatelli F, Lo Nigro L, Luciani M, Messina C, Micalizzi C, Parasole R, Pession A, Santoro N, Testi AM, Silvestri D, Basso G, Masera G, Conter V. Long-term results of the AIEOP-ALL-95 Trial for Childhood Acute Lymphoblastic Leukemia: insight on the prognostic value of DNA index in the framework of Berlin-Frankfurt-Muenster based chemotherapy. J Clin Oncol. 2008 Jan 10;26(2):283-9. doi: 10.1200/JCO.2007.12.3927.
PubMed 18182669Aznar S, Webster AL, San Juan AF, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Garcia-Castro J, Ramirez M, Madero L, Lucia A. Physical activity during treatment in children with leukemia: a pilot study. Appl Physiol Nutr Metab. 2006 Aug;31(4):407-13. doi: 10.1139/h06-014.
PubMed 16900230Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. doi: 10.2165/00007256-200838010-00004.
PubMed 18081366Geiger R, Strasak A, Treml B, Gasser K, Kleinsasser A, Fischer V, Geiger H, Loeckinger A, Stein JI. Six-minute walk test in children and adolescents. J Pediatr. 2007 Apr;150(4):395-9, 399.e1-2. doi: 10.1016/j.jpeds.2006.12.052.
PubMed 17382117Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
PubMed 21370414Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18.
PubMed 23599231Hartman A, te Winkel ML, van Beek RD, de Muinck Keizer-Schrama SM, Kemper HC, Hop WC, van den Heuvel-Eibrink MM, Pieters R. A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 Jul;53(1):64-71. doi: 10.1002/pbc.21942.
PubMed 19283791Haupt R, Spinetta JJ, Ban I, Barr RD, Beck JD, Byrne J, Calaminus G, Coenen E, Chesler M, D'Angio GJ, Eiser C, Feldges A, Gibson F, Lackner H, Masera G, Massimo L, Magyarosy E, Otten J, Reaman G, Valsecchi MG, Veerman AJ, Penn A, Thorvildsen A, van den Bos C, Jankovic M; International Berlin-Frankfurt-Munster Study Group Early and Late Toxicity Educational Committee (I-BFM-SG ELTEC). Long term survivors of childhood cancer: cure and care. The Erice statement. Eur J Cancer. 2007 Aug;43(12):1778-80. doi: 10.1016/j.ejca.2007.04.015. Epub 2007 May 31.
PubMed 17543517Hogarty AN, Leahey A, Zhao H, Hogarty MD, Bunin N, Cnaan A, Paridon SM. Longitudinal evaluation of cardiopulmonary performance during exercise after bone marrow transplantation in children. J Pediatr. 2000 Mar;136(3):311-7. doi: 10.1067/mpd.2000.103444.
PubMed 10700686Jenney ME, Faragher EB, Jones PH, Woodcock A. Lung function and exercise capacity in survivors of childhood leukaemia. Med Pediatr Oncol. 1995 Apr;24(4):222-30. doi: 10.1002/mpo.2950240403.
PubMed 7700166San Juan AF, Fleck SJ, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Cardona C, Del Valle MF, Hernandez M, Ramirez M, Madero L, Lucia A. Effects of an intrahospital exercise program intervention for children with leukemia. Med Sci Sports Exerc. 2007 Jan;39(1):13-21. doi: 10.1249/01.mss.0000240326.54147.fc.
PubMed 17218878San Juan AF, Fleck SJ, Chamorro-Vina C, Mate-Munoz JL, Moral S, Garcia-Castro J, Ramirez M, Madero L, Lucia A. Early-phase adaptations to intrahospital training in strength and functional mobility of children with leukemia. J Strength Cond Res. 2007 Feb;21(1):173-7. doi: 10.1519/00124278-200702000-00031.
PubMed 17313277Lucia A, Ramirez M, San Juan AF, Fleck SJ, Garcia-Castro J, Madero L. Intrahospital supervised exercise training: a complementary tool in the therapeutic armamentarium against childhood leukemia. Leukemia. 2005 Aug;19(8):1334-7. doi: 10.1038/sj.leu.2403799. No abstract available.
PubMed 15931268Maggiani A, Tremolizzo L, Della Valentina A, Mapelli L, Sosio S, Milano V, Bianchi M, Badi F, Lavazza C, Grandini M, Corna G, Prometti P, Lunetta C, Riva N, Ferri A, Lanfranconi F; ME&SLA Study #. Osteopathic Manual Treatment for Amyotrophic Lateral Sclerosis: A Feasibility Pilot Study. Open Neurol J. 2016 Aug 26;10:59-66. doi: 10.2174/1874205X01610010059. eCollection 2016.
PubMed 27651843
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project
- ClinicalTrials.gov ID
- NCT04090268
- Acronym / sponsor ID
- SportTherapy / 284 BIONDI
- Conditions
- Leukemia, Myeloid, Acute, Leukemia, B-cell, Leukemia, T Cell, Lymphoma, Hodgkin, Lymphoma, Non-Hodgkin, Drepanocytosis
- Keywords
- exercise, children, adolescent, cancer, malignant hemopathies, leukemia, lymphoma, hematopoietic stem cell transplant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 380 participants (estimated)
- Lead sponsor
- University of Milano BicoccaUniversity, hospital or other
- Collaborators
- Comitato Maria Letizia Verga,Italy
- Study start
- 3 Apr 2017 (actual)
- Primary completion
- 3 Apr 2025 (estimated)
- Study completion
- 3 Apr 2026 (estimated)
- First posted
- 16 Sep 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)
| Arm | Type | Receives |
|---|---|---|
| Children with malignant hemopathies | Experimental | Other: Sport TherapyChildren with malignant hemopathies attending a precision exercise training |
| Healthy children | No intervention | –Healthy children |
Who may qualify
- Ages
- 2 to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- Children with malignant hemopathies attending the Maria Letizia Verga Center
Key exclusion criteria (1 listed)
- Children under 2 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sport TherapyAlso: Precision exercise programChildren and adolescent with malignant hemopathies will attend a 3 days/weekly combined training | Other | Children with malignant hemopathies |
Primary outcome
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.
5 secondary outcomes
Change from baseline Satisfaction at 12 weeks
Time frame: 12 weeks
Change from baseline 6 minute walking test at 12 weeks
Time frame: 12 weeks
Change from baseline Time up and down stairs test at 12 weeks
Time frame: 12 weeks
Change from baseline yo yo test at 12 weeks
Time frame: 12 weeks
Change from baseline MOON test at 12 weeks
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2024.
- Background: PubMed 24956391Lanfranconi F, Pollastri L, Ferri A, Fraschini D, Masera G, Miserocchi G. Near infrared spectroscopy (NIRS) as a new non-invasive tool to detect oxidative skeletal muscle impairment in children survived to acute lymphoblastic leukaemia. PLoS One. 2014 Jun 23;9(6):e99282. doi: 10.1371/journal.pone.0099282. eCollection 2014.
- Background: PubMed 18182669Arico M, Valsecchi MG, Rizzari C, Barisone E, Biondi A, Casale F, Locatelli F, Lo Nigro L, Luciani M, Messina C, Micalizzi C, Parasole R, Pession A, Santoro N, Testi AM, Silvestri D, Basso G, Masera G, Conter V. Long-term results of the AIEOP-ALL-95 Trial for Childhood Acute Lymphoblastic Leukemia: insight on the prognostic value of DNA index in the framework of Berlin-Frankfurt-Muenster based chemotherapy. J Clin Oncol. 2008 Jan 10;26(2):283-9. doi: 10.1200/JCO.2007.12.3927.
- Background: PubMed 16900230Aznar S, Webster AL, San Juan AF, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Garcia-Castro J, Ramirez M, Madero L, Lucia A. Physical activity during treatment in children with leukemia: a pilot study. Appl Physiol Nutr Metab. 2006 Aug;31(4):407-13. doi: 10.1139/h06-014.
- Background: PubMed 18081366Bangsbo J, Iaia FM, Krustrup P. The Yo-Yo intermittent recovery test : a useful tool for evaluation of physical performance in intermittent sports. Sports Med. 2008;38(1):37-51. doi: 10.2165/00007256-200838010-00004.
- Background: PubMed 17382117Geiger R, Strasak A, Treml B, Gasser K, Kleinsasser A, Fischer V, Geiger H, Loeckinger A, Stein JI. Six-minute walk test in children and adolescents. J Pediatr. 2007 Apr;150(4):395-9, 399.e1-2. doi: 10.1016/j.jpeds.2006.12.052.
- Background: PubMed 21370414Gohar SF, Comito M, Price J, Marchese V. Feasibility and parent satisfaction of a physical therapy intervention program for children with acute lymphoblastic leukemia in the first 6 months of medical treatment. Pediatr Blood Cancer. 2011 May;56(5):799-804. doi: 10.1002/pbc.22713. Epub 2011 Jan 16.
- Background: PubMed 23599231Gotte M, Kesting S, Albrecht C, Worth A, Bos K, Boos J. MOON-test - determination of motor performance in the pediatric oncology. Klin Padiatr. 2013 May;225(3):133-7. doi: 10.1055/s-0033-1343411. Epub 2013 Apr 18.
- Background: PubMed 19283791Hartman A, te Winkel ML, van Beek RD, de Muinck Keizer-Schrama SM, Kemper HC, Hop WC, van den Heuvel-Eibrink MM, Pieters R. A randomized trial investigating an exercise program to prevent reduction of bone mineral density and impairment of motor performance during treatment for childhood acute lymphoblastic leukemia. Pediatr Blood Cancer. 2009 Jul;53(1):64-71. doi: 10.1002/pbc.21942.
- Background: PubMed 17543517Haupt R, Spinetta JJ, Ban I, Barr RD, Beck JD, Byrne J, Calaminus G, Coenen E, Chesler M, D'Angio GJ, Eiser C, Feldges A, Gibson F, Lackner H, Masera G, Massimo L, Magyarosy E, Otten J, Reaman G, Valsecchi MG, Veerman AJ, Penn A, Thorvildsen A, van den Bos C, Jankovic M; International Berlin-Frankfurt-Munster Study Group Early and Late Toxicity Educational Committee (I-BFM-SG ELTEC). Long term survivors of childhood cancer: cure and care. The Erice statement. Eur J Cancer. 2007 Aug;43(12):1778-80. doi: 10.1016/j.ejca.2007.04.015. Epub 2007 May 31.
- Background: PubMed 10700686Hogarty AN, Leahey A, Zhao H, Hogarty MD, Bunin N, Cnaan A, Paridon SM. Longitudinal evaluation of cardiopulmonary performance during exercise after bone marrow transplantation in children. J Pediatr. 2000 Mar;136(3):311-7. doi: 10.1067/mpd.2000.103444.
- Background: PubMed 7700166Jenney ME, Faragher EB, Jones PH, Woodcock A. Lung function and exercise capacity in survivors of childhood leukaemia. Med Pediatr Oncol. 1995 Apr;24(4):222-30. doi: 10.1002/mpo.2950240403.
- Background: PubMed 17218878San Juan AF, Fleck SJ, Chamorro-Vina C, Mate-Munoz JL, Moral S, Perez M, Cardona C, Del Valle MF, Hernandez M, Ramirez M, Madero L, Lucia A. Effects of an intrahospital exercise program intervention for children with leukemia. Med Sci Sports Exerc. 2007 Jan;39(1):13-21. doi: 10.1249/01.mss.0000240326.54147.fc.
- Sport Therapy project pageLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Oxidative metabolism and MOON test variables will be shared with other colleagues involved in similar research protocols
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adriana Balduzzi, MD, PhD contact
Andrea Biondi, MD, PhD principal investigator
University of Milano Bicocca
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sport Therapy in people with Leukemia, Myeloid, Acute and Leukemia, B-cell, run by University of Milano Bicocca at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Francesca Lanfranconi, MD, PhD (+39 0392336868, francesca.lanfranconi@unimib.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline oxidative metabolism at 12 weeks (time frame: 12 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04090268, which also lists 18 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2024.