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

NCT03842735 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2021-03-22

No results posted yet for this study

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

Interventions

OTHER

exercise and rehabilitation counselling

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).

BEHAVIORAL

rehabilitation counselling

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).

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Francesca Rossi, Dr · A.O.U. Città della Salute e della Scienza - OIRM, Turin, Italy

Study Design

Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
6 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-05-23
Primary Completion
2019-12-31
Completion
2020-02-28

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03842735 on ClinicalTrials.gov