Precision Exercise in Children With Malignant Hemopathies

NCT04090268 | Recruiting

• 1 other identifier: 284 BIONDI
• Study Type: interventional
• Target: 380
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (4)

• Change from baseline oxidative metabolism at 12 weeks

  Maximal O2 uptake and skeletal muscle O2 extraction

  12 weeks

• Change from baseline strength of upper and lower limbs (1RM) at 12 weeks

  1 repetition maximal

  12 weeks

• Change from baseline balance at 12 weeks

  Stabilometry

  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.

  12 weeks

Secondary Outcomes (5)

• Change from baseline Satisfaction at 12 weeks

  12 weeks

• Change from baseline 6 minute walking test at 12 weeks

  12 weeks

• Change from baseline Time up and down stairs test at 12 weeks

  12 weeks

• Change from baseline yo yo test at 12 weeks

  12 weeks

• Change from baseline MOON test at 12 weeks

  12 weeks

Study Arms (2)

Children with malignant hemopathies

EXPERIMENTAL

Children with malignant hemopathies attending a precision exercise training

Other: Sport Therapy

Healthy children

NO INTERVENTION

Healthy children

Interventions

Sport Therapy OTHER

Children and adolescent with malignant hemopathies will attend a 3 days/weekly combined training

Also known as: Precision exercise program

Children with malignant hemopathies

Eligibility Criteria

• Age: 2 Years - 18 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Children with malignant hemopathies attending the Maria Letizia Verga Center

You may not qualify if:

• Children under 2 years

Sponsors & Collaborators

• University of Milano Bicocca: lead
• Comitato Maria Letizia Verga,Italy: collaborator

Study Sites (1)

Maria Letizia Verga Center, Pediatric Clinic, University of Milan Bicocca, at the Foundation for the Mother and Her Child

Monza, MB, 20900, Italy

RECRUITING

Related Publications (18)

• 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.

  PMID: 24956391 BACKGROUND

• 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.

  PMID: 18182669 BACKGROUND

• 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.

  PMID: 16900230 BACKGROUND

• 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.

  PMID: 18081366 BACKGROUND

• 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.

  PMID: 17382117 BACKGROUND

• 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.

  PMID: 21370414 BACKGROUND

• 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.

  PMID: 23599231 BACKGROUND

• 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.

  PMID: 19283791 BACKGROUND

• 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.

  PMID: 17543517 BACKGROUND

• 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.

  PMID: 10700686 BACKGROUND

• 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.

  PMID: 7700166 BACKGROUND

• 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.

  PMID: 17218878 BACKGROUND

• 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.

  PMID: 17313277 BACKGROUND

• 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.

  PMID: 15931268 BACKGROUND

• 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.

  PMID: 27651843 BACKGROUND

• 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.

  PMID: 12030409 BACKGROUND

• 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.

  PMID: 23099236 BACKGROUND

• 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.

  PMID: 17057533 BACKGROUND

Related Links

• Sport Therapy project page

MeSH Terms

Conditions

Leukemia, Myeloid, Acute; Leukemia, B-Cell; Leukemia, T-Cell; Hodgkin Disease; Lymphoma, Non-Hodgkin; Sickle Cell Trait; beta-Thalassemia; Adrenoleukodystrophy; Motor Activity; Neoplasms; Leukemia; Lymphoma

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Neoplasms by Histologic Type; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases; Anemia, Sickle Cell; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Thalassemia; Brain Diseases, Metabolic, Inborn; Brain Diseases, Metabolic; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hereditary Central Nervous System Demyelinating Diseases; Leukoencephalopathies; Demyelinating Diseases; X-Linked Intellectual Disability; Intellectual Disability; Neurobehavioral Manifestations; Neurologic Manifestations; Genetic Diseases, X-Linked; Heredodegenerative Disorders, Nervous System; Metabolism, Inborn Errors; Peroxisomal Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Adrenal Insufficiency; Adrenal Gland Diseases; Endocrine System Diseases; Behavior

Study Officials

• Andrea Biondi, MD, PhD

  University of Milano Bicocca

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Francesca Lanfranconi, MD, PhD

CONTACT

+39 0392336868; francesca.lanfranconi@unimib.it

Adriana Balduzzi, MD, PhD

CONTACT

adriana.balduzzi@unimib.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Analytical study, stratified, evaluating the impact of a non-pharmacological treatment (training)

Study Record Dates

• First Submitted: June 2, 2019
• First Posted: September 16, 2019
• Study Start: April 3, 2017
• Primary Completion: April 3, 2025
• Study Completion: April 3, 2026
• Last Updated: January 2, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: SAP, ICF
• Time Frame: In July 2019 data will be shared, forever
• Access Criteria: Invitation of a common folder in google drive

Locations

IT (1)