search
Back to results

Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation (EVAADE)

Primary Purpose

Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Physical activity program
Sponsored by
Centre Leon Berard
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Haematological Malignancy

Eligibility Criteria

8 Years - 21 Years (Child, Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 8 years ≤ Age ≤ 21 years
  • Height ≥ 110 cm
  • Histologically or cytologically confirmed malignant or non-malignant haemopathy
  • Indication for hematopoietic stem cell transplantation
  • Hospitalization in a sterile room in the investigating center
  • Certificate of no contraindicatication to practice an APA, issued by the oncologist or the attending physician
  • Having a smartphone available in the sterile room (iOS version 12 (iPhone/Apple) or 6 under Android at least) for playing connected games
  • Signed and dated written consent (patient or parents of minor patients with obtaining the minor's acceptance)

Exclusion Criteria:

  • Severe heart disease and uncontrolled cardiovascular disease

Temporary contraindications

  • Severe anemia (hemoglobin ≤ 8 g/dl) will need to be treated (transfusion of red blood cells [RBCs]) before resuming the physical activity program.
  • Severe infectious syndrome in progress and/or febrile feeling with accompanying signs (productive cough, muscle pain).

Inclusion criteria for relatives :

  • Person visiting the patient in a sterile room during the hospital stay
  • At least 8 years old
  • Height ≥ 110 cm
  • Have a smartphone (iOS version 12 (iPhone/Apple) or 6 under Android at least) for the realization of the connected games.
  • Not having any contraindication to physical activity.
  • Signed and dated written consent (minor's relative or parents with the minor's acceptance).

Sites / Locations

  • Institut d'Hématologie et d'Oncologie PédiatriqueRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Physical activity intervention

Arm Description

The intervention will take place during the whole isolation phase and will consist of an APA program defined at inclusion, integrating supervised sessions with an APA teacher, as well as unsupervised sessions. The program will be individualized according to the patient's age, physical condition and PA preferences. The sessions will also be adapted to the biological, psychological and social parameters of the patients. The intervention will be carried out during the entire hospitalization period and for a maximum of 3 months. An connected bike will be installed in the patient's room for the duration of the hospitalization.

Outcomes

Primary Outcome Measures

observance to the physical activity program
achieved/non achieved (achieved meaning the patient attended at least one session of 15 minutes weekly during the whole program, considering both supervised and unsupervised sessions)

Secondary Outcome Measures

Impact of unsupervised sessions on patients' PA practice
Rate of unsupervised sessions/total of performed sessions
Impact of the physical activity program on weight
weight in kgs
Impact of the physical activity on waist circumference
waist circumference assessed in cm
Impact of the physical activity program on hip circumference
hip circumference assessed in cm
Impact of the physical activity program on body mass index
weight/(size)^2
Impact of the physical activity program on endurance capacity
Harvard step test
Impact of the physical activity program on muscle strength
Dynanometer
Impact of the physical activity program on fatigue
Visual analogic scale from 0 to 10
Self efficacy feeling
HAPA questionnaire
Motivation towards physical activity
BREQ-2 questionnaire
Impact of the PA program on metabolic syndrome
Lipid check-up
Impact of social environment of PA practice
PA practice of patient / PA practice of relatives
Overall satisfaction
Likert-scale questionnaire
Acceptability of the intervention
Number of enrolled patients/number of eligible patients

Full Information

First Posted
March 3, 2022
Last Updated
March 31, 2023
Sponsor
Centre Leon Berard
search

1. Study Identification

Unique Protocol Identification Number
NCT05298930
Brief Title
Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation
Acronym
EVAADE
Official Title
A Feasibility Study Evaluating Connected Bikes as a Means of Adapted Physical Activity in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
May 25, 2022 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Leon Berard

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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 narrow 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 remain 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 occurence of severe infectious episodes, aHSCT must be performed in a highly protected environment (positive pressure chambers). This has consequences for the experience and impact of hospitalization on the patient and family. This is particularly true in pediatrics, with children, adolescents or young adults, where it is not only the patient's quality of life that is at stake, but also his emotional and psychomotor development. In this specific population, prolonged hospitalization (at least 6 weeks) in a sterile room will be responsible for physical deconditioning accompanied by a decrease in muscle mass. Patients often experience an deteriorated quality of life. Today, the benefits of physical activity (PA) during and after cancer treatment have been widely demonstrated. The objective of the study is to assess 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 will be based on an adapted physical activity (APA) program defined at inclusion, integrating supervised sessions with an APA teacher, as well as autonomous sessions performed by means of a connected bike in the sterile room. The program will be individualized according to age, aerobic capacities, and PA preferences. Sessions will also be 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 old requiring aHSCT during the sterile isolation phase. EVAADE will therefore be the first study in this population to offer an innovative procedure with a connected device.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes, Hemoglobinopathy in Children, Bone Marrow Aplasia, Severe Combined Immunodeficiency

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Physical activity intervention
Arm Type
Experimental
Arm Description
The intervention will take place during the whole isolation phase and will consist of an APA program defined at inclusion, integrating supervised sessions with an APA teacher, as well as unsupervised sessions. The program will be individualized according to the patient's age, physical condition and PA preferences. The sessions will also be adapted to the biological, psychological and social parameters of the patients. The intervention will be carried out during the entire hospitalization period and for a maximum of 3 months. An connected bike will be installed in the patient's room for the duration of the hospitalization.
Intervention Type
Other
Intervention Name(s)
Physical activity program
Intervention Description
The supervised sessions will be offered 4 times a week in the participants' rooms by the APA teachers and will include moderate intensity aerobic activities (exercise bike), muscle strengthening (dumbbells, elastic bands, medicine balls) and playful situations (ball games, cooperative games, body expression games). Each patient will also be able to perform unsupervised sessions (on their own), following the advice given by the APA teacher. These unsupervised sessions can be done independently on the bike. In order to encourage patients to perform these unsupervised sessions, patients and their relatives will be given a connected device and will have access to a mobile application developed by the Kiplin company, which offers connected physical activity games to be performed in teams (from 2 to 4 participants). These games, lasting from 1 to 3 weeks, use the participants' daily PA level as a unit of animation and are punctuated by challenges.
Primary Outcome Measure Information:
Title
observance to the physical activity program
Description
achieved/non achieved (achieved meaning the patient attended at least one session of 15 minutes weekly during the whole program, considering both supervised and unsupervised sessions)
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Impact of unsupervised sessions on patients' PA practice
Description
Rate of unsupervised sessions/total of performed sessions
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on weight
Description
weight in kgs
Time Frame
baseline, 3 months
Title
Impact of the physical activity on waist circumference
Description
waist circumference assessed in cm
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on hip circumference
Description
hip circumference assessed in cm
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on body mass index
Description
weight/(size)^2
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on endurance capacity
Description
Harvard step test
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on muscle strength
Description
Dynanometer
Time Frame
baseline, 3 months
Title
Impact of the physical activity program on fatigue
Description
Visual analogic scale from 0 to 10
Time Frame
baseline, 3 months
Title
Self efficacy feeling
Description
HAPA questionnaire
Time Frame
3 months
Title
Motivation towards physical activity
Description
BREQ-2 questionnaire
Time Frame
baseline, 3 months
Title
Impact of the PA program on metabolic syndrome
Description
Lipid check-up
Time Frame
baseline, 3 months
Title
Impact of social environment of PA practice
Description
PA practice of patient / PA practice of relatives
Time Frame
3 months
Title
Overall satisfaction
Description
Likert-scale questionnaire
Time Frame
3 months
Title
Acceptability of the intervention
Description
Number of enrolled patients/number of eligible patients
Time Frame
baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 8 years ≤ Age ≤ 21 years Height ≥ 110 cm Histologically or cytologically confirmed malignant or non-malignant haemopathy Indication for hematopoietic stem cell transplantation Hospitalization in a sterile room in the investigating center Certificate of no contraindicatication to practice an APA, issued by the oncologist or the attending physician Having a smartphone available in the sterile room (iOS version 12 (iPhone/Apple) or 6 under Android at least) for playing connected games Signed and dated written consent (patient or parents of minor patients with obtaining the minor's acceptance) Exclusion Criteria: Severe heart disease and uncontrolled cardiovascular disease Temporary contraindications Severe anemia (hemoglobin ≤ 8 g/dl) will need to be treated (transfusion of red blood cells [RBCs]) before resuming the physical activity program. Severe infectious syndrome in progress and/or febrile feeling with accompanying signs (productive cough, muscle pain). Inclusion criteria for relatives : Person visiting the patient in a sterile room during the hospital stay At least 8 years old Height ≥ 110 cm Have a smartphone (iOS version 12 (iPhone/Apple) or 6 under Android at least) for the realization of the connected games. Not having any contraindication to physical activity. Signed and dated written consent (minor's relative or parents with the minor's acceptance).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Rodolf MONGONDRY, MSc
Phone
0469856272
Email
rodolf.mongondry@lyon.unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Olivia PEROL, MSc
Email
olivia.perol@lyon.unicancer.fr
Facility Information:
Facility Name
Institut d'Hématologie et d'Oncologie Pédiatrique
City
Lyon
ZIP/Postal Code
69008
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Carine HALFON-DOMENECH, MD
Email
Carine.HALFONDOMENECH@ihope.fr
First Name & Middle Initial & Last Name & Degree
Cécile RENARD, MD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation

We'll reach out to this number within 24 hrs