Physical Activity in Children During Hematopoietic Stem Cells Transplantation (HSCT)

NCT03842735 | Completed

• 1 other identifier: PHYSICALACTIVITYHSCT0-18YSIPP
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

This interventional study was designed to assess the validity and the impact of a rehabilitation program on pediatric cancer patients undergoing hematopoietic stem cells transplantation (HSCT). Each participant will be randomly assigned to either an experimental or control (counseling rehabilitation care) group. The experimental group participate in an inpatient rehabilitation program for the duration of HSCT pathway. The program include standardized activities for 5 days a week in the child's room or in a pediatric gym at the hospital.

Conditions

Hematopoietic Stem Cell Transplantation; Child; Adolescent

Keywords

Physiotherapy; Rehabilitation; Exercise

Outcome Measures

Primary Outcomes (5)

• change in global motor skills level

  The Gross Motor Function Measure (GMFM), version -88 for children who aged between 0-4 years, and version-Acute Lymphoblastic Leukemia (ALL) for older subjects. The GMFM-88 is composed by 88 items, while the GMFM-ALL is composed by 21 items. Each item can be scored as 0, 1, 2, 3, or "not tested". Scoring key: 0 - does not initiate, 1 - initiates, 2 - partially completes, and 3 - completed. The total score for GMFM-88 can be between 0 and 264, while for the GMFM-ALL can vary from 0 to 63.

  this outcome it is measured in the week before HSCT [Time 0] and post hematopoietic stem cells transplantation (HSCT), after the discharge from stem cells unit (SCU), at an average of 40 days after Time 0 [Time 1]

• change in range of passive ankle dorsiflexion

  Goniometer

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

• rate of immune cells recovery

  blood counts of leukocytes, monocytes, and lymphocytes and main lymphocyte subpopulations and dendritic cells

  this outcome it is measured 35 days after the first day of infusion ("day zero")

• participation rate at the exercise program

  Parents are required to record in appropriate grids their child's daily activities and adolescents fill them in themselves. The therapist goes 3 times/week to check that the diary is filled in correctly. This outcome it is measured daily during the stay in the SCU.

  24 hours

• adhesion rate to rehabilitative counselling indications

  Parents are required to record in appropriate grids their child's daily activities and adolescents fill them in themselves. The therapist goes 3 times/week to check that the diary is filled in correctly. This outcome it is measured daily during the stay in the SCU.

  24 hours

Secondary Outcomes (6)

• change in functional motility level

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

• change in tibialis anterior and quadriceps muscles strength level

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

• change in flexibility level of the lower back and hamstring muscles

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

• change in functional exercise capacity level

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

• change in fatigue level

  this outcome it is measured in the week before HSCT [Time 0] and post HSCT, after the discharge from SCU, at an average of 40 days after Time 0 [Time 1]

Study Arms (2)

exercise and rehabilitation counselling

EXPERIMENTAL

Subjects enrolled in exercise group make physical exercises and receive rehabilitative counselling indications

Other: exercise and rehabilitation counselling; Behavioral: rehabilitation counselling

rehabilitation counselling

OTHER

Subjects enrolled in exercise group only receive rehabilitative counseling indications.

Behavioral: rehabilitation counselling

Interventions

exercise and rehabilitation counselling OTHER

The intervention consists in a standardized physical exercise (PE) and rehabilitation counselling indications (RCI). PE is done 5 days/week (2 days in autonomy by the patient with parents support and 3 days supervised). Each session lasts 30 minutes and this is supervised by one therapist for all patients. Patients are enrolled in an EP composed by three different types of exercises, each carried out for 10 minutes per session: muscle strength exercises for upper and lower extremities preceded by warming up, aerobic exercises and stretching. The kind of exercise is differentiated by age range (children, 5-12 years and adolescents, 13-18 years).

Also known as: rehabilitation

exercise and rehabilitation counselling

rehabilitation counselling BEHAVIORAL

RCI, which have to be followed daily, consist in some practical advice was given on how to adopt an active lifestyle during the recovery (e.g., getting up to go to the bathroom, getting up to move to the window to talk with visitors, sit on chair to have school lessons).

exercise and rehabilitation counselling; rehabilitation counselling

Eligibility Criteria

• Age: 6 Months - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• i) being children or adolescents (6 months -18 years old);
• ii) to have a diagnosis of oncological or hematological disease;
• iii) receiving an autologous or allogeneic HSCT;
• iv) to have spoken and written Italian language comprehension, both by children/adolescents and by parents.

You may not qualify if:

• i) to be affected by cognitive difficulties that preclude to the program's participation;
• ii) to be already undergoing rehabilitation before the entrance in the Transplantation Stem Cell Unit (TSCU).

Sponsors & Collaborators

• A.O.U. Città della Salute e della Scienza: lead

Study Sites (1)

A.O.U. Città della Salute e della Scienza - Regina Margherita children hospital

Turin, 10126, Italy

Location

Related Publications (13)

• Rossi F, Coppo M, Zucchetti G, Bazzano D, Ricci F, Vassallo E, Nesi F, Fagioli F. Rehabilitative intervention during and after pediatric hematopoietic stem cell transplantation: An analysis of the existing literature. Pediatr Blood Cancer. 2016 Nov;63(11):1895-904. doi: 10.1002/pbc.26114. Epub 2016 Jul 13.

  PMID: 27409063 BACKGROUND

• Fiuza-Luces C, Soares-Miranda L, Gonzalez-Murillo A, Palacio JM, Colmenero I, Casco F, Melen GJ, Delmiro A, Moran M, Ramirez M, Lucia A. Exercise benefits in chronic graft versus host disease: a murine model study. Med Sci Sports Exerc. 2013 Sep;45(9):1703-11. doi: 10.1249/MSS.0b013e31828fa004.

  PMID: 23954992 BACKGROUND

• Fiuza-Luces C, Gonzalez-Murillo A, Soares-Miranda L, Martinez Palacio J, Colmenero I, Casco F, Melen G, Moran M, Lucia A, Ramirez M. Effects of exercise interventions in graft-versus-host disease models. Cell Transplant. 2013;22(12):2409-20. doi: 10.3727/096368912X658746. Epub 2012 Oct 31.

  PMID: 23127525 BACKGROUND

• Timmons BW, Cieslak T. Human natural killer cell subsets and acute exercise: a brief review. Exerc Immunol Rev. 2008;14:8-23.

  PMID: 19203081 BACKGROUND

• Chamorro-Vina C, Ruiz JR, Santana-Sosa E, Gonzalez Vicent M, Madero L, Perez M, Fleck SJ, Perez A, Ramirez M, Lucia A. Exercise during hematopoietic stem cell transplant hospitalization in children. Med Sci Sports Exerc. 2010 Jun;42(6):1045-53. doi: 10.1249/MSS.0b013e3181c4dac1.

  PMID: 19997035 BACKGROUND

• Rosenhagen A, Bernhorster M, Vogt L, Weiss B, Senn A, Arndt S, Siegler K, Jung M, Bader P, Banzer W. Implementation of structured physical activity in the pediatric stem cell transplantation. Klin Padiatr. 2011 May;223(3):147-51. doi: 10.1055/s-0031-1271782. Epub 2011 Apr 1.

  PMID: 21462101 BACKGROUND

• Hayes S, Davies PS, Parker T, Bashford J, Newman B. Quality of life changes following peripheral blood stem cell transplantation and participation in a mixed-type, moderate-intensity, exercise program. Bone Marrow Transplant. 2004 Mar;33(5):553-8. doi: 10.1038/sj.bmt.1704378.

  PMID: 14716346 BACKGROUND

• Chamorro-Vina C, Guilcher GM, Khan FM, Mazil K, Schulte F, Wurz A, Williamson T, Reimer RA, Culos-Reed SN. EXERCISE in pediatric autologous stem cell transplant patients: a randomized controlled trial protocol. BMC Cancer. 2012 Sep 10;12:401. doi: 10.1186/1471-2407-12-401.

  PMID: 22963378 BACKGROUND

• Tanir MK, Kuguoglu S. Impact of exercise on lower activity levels in children with acute lymphoblastic leukemia: a randomized controlled trial from Turkey. Rehabil Nurs. 2013 Jan-Feb;38(1):48-59. doi: 10.1002/rnj.58. Epub 2012 Oct 18.

  PMID: 23365005 BACKGROUND

• Hartman A, Hop W, Takken T, Pieters R, van den Heuvel-Eibrink M. Motor performance and functional exercise capacity in survivors of pediatric acute lymphoblastic leukemia. Pediatr Blood Cancer. 2013 Mar;60(3):494-9. doi: 10.1002/pbc.24243. Epub 2012 Jun 28.

  PMID: 22745035 BACKGROUND

• Moyer-Mileur LJ, Ransdell L, Bruggers CS. Fitness of children with standard-risk acute lymphoblastic leukemia during maintenance therapy: response to a home-based exercise and nutrition program. J Pediatr Hematol Oncol. 2009 Apr;31(4):259-66. doi: 10.1097/MPH.0b013e3181978fd4.

  PMID: 19346877 BACKGROUND

• Braam KI, van der Torre P, Takken T, Veening MA, van Dulmen-den Broeder E, Kaspers GJ. Physical exercise training interventions for children and young adults during and after treatment for childhood cancer. Cochrane Database Syst Rev. 2016 Mar 31;3(3):CD008796. doi: 10.1002/14651858.CD008796.pub3.

  PMID: 27030386 BACKGROUND

• Rossi F, Zucchetti G, Esposito M, Berchialla P, Sciannameo V, Vassallo E, Saglio F, Chamorro Vina C, Scarrone S, Vittorini R, Fagioli F. Rehabilitation in children and adolescents undergoing stem cell transplantation: A pilot study focused on motor performance. Eur J Cancer Care (Engl). 2022 Nov;31(6):e13711. doi: 10.1111/ecc.13711. Epub 2022 Sep 28.

  PMID: 36168857 DERIVED

MeSH Terms

Conditions

Motor Activity

Interventions

Exercise; Rehabilitation

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Francesca Rossi, Dr

  A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Development Neuro and Psychomotor Therapist

Model Details: Eligible patients who provided consent were assigned to one of the two groups according to a "cluster time" selection model. The methodology was discussed and agreed with expert methodologists of the A.O.U. Città della Salute e della Scienza research group and based assignation to the two groups according to the time of hospitalization: EG enrollment May 2016-December 2016, March 2017-May 2017, November 2017-June 2018 and CG enrollment January 2017-February 2017, June 2017-October 2017, July 2018-August 2018.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 15, 2019
• Study Start: May 23, 2016
• Primary Completion: December 31, 2019
• Study Completion: February 28, 2020
• Last Updated: March 22, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)