Precision Exercise in Children With Malignant Hemopathies

Lymphoma, Non-Hodgkin Clinical Trial

— SportTherapy  

Official title:

Precision Exercise Program in Children With Malignant Hemopathies Undergoing Therapy and/or Hematopoietic Stem Cell Transplantation: The "Sport Therapy" Project

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04090268
• Other study ID #: 284 BIONDI
• Status: Recruiting
• Phase: N/A
• Start date: April 3, 2017
• Est. completion date: April 3, 2026

Study information

• Verified date: December 2023
• Source: University of Milano Bicocca
• Contact: Francesca Lanfranconi, MD, PhD
• Phone: +39 0392336868
• Email: francesca.lanfranconi[@]unimib.it
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Adrenoleukodystrophy
• beta-Thalassemia
• Drepanocytosis
• Hodgkin Disease
• Leukemia
• Leukemia, B-Cell
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Leukemia, T Cell
• Leukemia, T-Cell
• Lymphoma
• Lymphoma, Hodgkin
• Lymphoma, Non-Hodgkin
• Thalassemia
• Thalassemia Major

Intervention

Other:
• Sport Therapy
Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
University of Milano Bicocca	Comitato Maria Letizia Verga,Italy

Country where clinical trial is conducted

Italy, 

References & Publications (18)

Arico 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. — View Citation

Aznar 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. — View Citation

Bangsbo 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. — View Citation

Geiger 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. — View Citation

Gohar 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. — View Citation

Gotte 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. — View Citation

Hartman 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. — View Citation

Haupt 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. — View Citation

Hogarty 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. — View Citation

Jenney 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. — View Citation

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. — View Citation

Lucia 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. — View Citation

Maggiani 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. — View Citation

Nagashima T, Sato F, Chuma T, Mano Y, Sasaki I, Mori M, Higa T, Masauji N, Kasai M, Orba Y, Shinohara T, Nagashima K. Chronic demyelinating polyneuropathy in graft-versus-host disease following allogeneic bone marrow transplantation. Neuropathology. 2002 Mar;22(1):1-8. — View Citation

San 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. — View Citation

San 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. — View Citation

Tan SY, Poh BK, Chong HX, Ismail MN, Rahman J, Zarina AL, Juraida AR, Tahir A, Ruzita AT, Roslee R, Shanita SN, Hamidah A, Shah MI, Norimah AK. Physical activity of pediatric patients with acute leukemia undergoing induction or consolidation chemotherapy. Leuk Res. 2013 Jan;37(1):14-20. doi: 10.1016/j.leukres.2012.09.005. Epub 2012 Oct 23. — View Citation

Zaino CA, Marchese VG, Westcott SL. Timed up and down stairs test: preliminary reliability and validity of a new measure of functional mobility. Pediatr Phys Ther. 2004 Summer;16(2):90-8. doi: 10.1097/01.PEP.0000127564.08922.6A. — View Citation

* Note: There are 18 references in all — Click here to view all references

Outcome

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

External Links

•   Sport Therapy project page