A Study to Assess a Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts

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Brief Title

A Study to Assess a Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts

Official Title

A Feasibility Study to Assess Connected Bikes as a Means of Adapted Physical Activity in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts

Brief Summary

      To date, allogeneic haematopoietic stem cell transplantation (aHSCT) is the only curative
      treatment for many paediatric and young adult haematological pathologies (acute leukaemia,
      myelodysplastic syndromes, haemoglobinopathies, bone marrow aplasia, severe combined
      immunodeficiency). Despite the major therapeutic progress made over the last 50 years,
      particularly in terms of supportive care, post-transplant morbidity and mortality remains
      high. Infectious complications, whose incidence varies between 30 and 60%, are the first
      cause of mortality in the immediate post-transplant period.

      In order to protect the patient from the occurrence of severe infectious episodes, aHSCTmust
      be performed in a highly protected environment (positive pressure chambers).

      This has implications for the experience and impact of hospitalization on the patient and
      family. This is particularly true in paediatrics, whether in children, adolescents or young
      adults, where it is not only the patient's quality of life that is at stake, but also their
      emotional and psychomotor development. In these patients, prolonged hospitalization (at least
      6 weeks) in a sterile room will be responsible for physical deconditioning accompanied by a
      decrease in muscle mass, itself concomitant with undernutrition, and an increase in sedentary
      lifestyle. This prolonged hospitalisation in a sterile room, associated with myeloablative
      treatments, is therefore the cause of social isolation of patients, but it is also often
      synonymous with physical inactivity leading to a rapid decrease in physical condition,
      quality of life and an increase in fatigue.

      Today, the benefits of physical activity (PA) during and after cancer treatment have been
      widely demonstrated.

      The objective is to evaluate the feasibility of an adapted physical activity program during
      the isolation phase for achieving aHSCT in children, adolescents and young adults. This is a
      prospective, interventional, monocentric cohort study conducted at the Institute of
      Paediatric Haematology and Oncology in Lyon. The intervention will take place during the
      isolation phase and consists of an adapted physical activity (APA) program defined at
      inclusion, integrating supervised sessions with an APA teacher, as well as autonomous
      sessions. The program is individualized according to age, aerobic capacity, and PA
      preferences. Sessions are also tailored to the biological, psychological, and social
      parameters of patients.

      The total duration of the intervention is 3 months. To date, no PA studies have been
      performed in patients under 21 years of age requiring aGCSH during the sterile isolation
      phase. EVAADE will therefore be the first study in this population to offer an innovative
      procedure with a connected device.
    



Study Type

Interventional


Primary Outcome

Observance to the physical activity program

Secondary Outcome

 Impact of the physical activity program on weight

Condition

Haematological Malignancy

Intervention

Physical activity program

Study Arms / Comparison Groups

 Physical activity intervention
Description:  The intervention consists of an adapted physical activity (APA) program defined at baseline, incorporating supervised sessions with an APA teacher, as well as autonomous sessions. The program is individualized according to age, aerobic capacity, and PA preferences.
The total duration of the intervention is a maximum of 3 months (during the period of hospitalization in a sterile room).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Other

Estimated Enrollment

30

Start Date

December 8, 2018

Completion Date

September 2023

Primary Completion Date

September 2023

Eligibility Criteria

        Inclusion Criteria:

          -  8 years ≤ Age ≤ 21 years

          -  Size more or equal to 110 cm.

          -  Histologically or cytologically confirmed malignant or non-malignant haemopathy

          -  Indication for hematopoietic stem cell allograft.

          -  Hospitalization in a protected room at IHOP/DAJAC.

          -  Certificate of no contraindication to the practice of an APA, issued by the oncologist
             or attending physician.

          -  Having available in the sterile room a smartphone (iPhone 5S version for Apple/version
             5 under Android at least) or a tablet (for the realization of the connected
             challenges) during the whole hospitalization period.

          -  Written consent signed and dated by the patient or the parents of minor patients with
             the acceptance of the minor.

        Exclusion Criteria:

          -  Severe Heart Disease and Uncontrolled Cardiovascular Disease
      

Gender

All

Ages

8 Years - 21 Years

Accepts Healthy Volunteers

No

Contacts

Carine HALFON-DOMENECH, MD, , 

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT04331483

Organization ID

EVAADE

Secondary IDs

ET18-184

Responsible Party

Sponsor

Study Sponsor

Centre Leon Berard


Study Sponsor

Carine HALFON-DOMENECH, MD, Principal Investigator, Institut d'Hematologie et d'Oncologie Pédiatrique


Verification Date

April 2020