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

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

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 Overview

• Status: Withdrawn
• Conditions: Myelodysplastic Syndromes; Severe Combined Immunodeficiency; Acute Leukemia; Haematological Malignancy; Hemoglobinopathy in Children; Bone Marrow Aplasia
• Intervention / Treatment: Other: Physical activity program

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lyon, France, 69008
    • Institut d'Hématologie et d'Oncologie Pédiatrique

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 4 years to 17 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Physical activity intervention; 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).

Other: Physical activity program; Supervised sessions of at least 15 minutes 4 times a Week combined with unsupervised sessions. The supervised activities 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 can also do unsupervised sessions, autonomously, on the bike thanks to a smartphone application developed by the Kiplin company, with challenges to be carried out by teams of 2 to 5 people (team including several patients, possibility to include relatives) over periods of 1 to 3 weeks per challenge.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Observance to the physical activity program	achieved/non-achieved (achived meaning the patient attended at least one session of 15 minutes weekly during the whole program	weekly from baseline to 3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Impact of the physical activity program on weight	weight in kgs	Baseline, 1 month and 3 months
Impact of the physical activity program on waist circumference	assessed in cm	Baseline, 1 month and 3 months
Impact of the physical activity program on hip circumference	assessed in cm	Baseline, 1 month and 3 months
Impact of the physical activity program on abdominal circumference	assessed in cm	Baseline, 1 month and 3 months
Impact of the physical activity program on body mass index	weight/(size)2	Baseline, 1 month and 3 months
Impact of the physical activity program on endurance capacity	Harvard step test	Baseline, 1 month and 3 months
Impact of the physical activity program on muscle strength	Dynamometer	Baseline, 1 month and 3 months
Impact of the physical activity program on fatigue	Visual analogic scale from 0 to 10	Baseline, 1 month and 3 months
Self-efficacy feeling	HAPA questionnaire	3 months
Motivation towards physical activity	BREQ questionnaire	Baseline, 1 month and 3 months
Impact of the PA program on metabolic syndrome	Lipid check-up	Baseline and 3 months

Collaborators and Investigators

• Sponsor: Centre Leon Berard
• Investigators: Principal Investigator: Carine HALFON-DOMENECH, MD, Institut d'Hématologie et d'Oncologie Pédiatrique

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2018
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): September 1, 2023

Study Registration Dates

• First Submitted: March 31, 2020
• First Submitted That Met QC Criteria: April 1, 2020
• First Posted (Actual): April 2, 2020

Study Record Updates

• Last Update Posted (Actual): February 28, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Neoplasms; Neoplasms by Site; Bone Marrow Diseases; Hematologic Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; Anemia; DNA Repair-Deficiency Disorders; Bone Marrow Failure Disorders; Primary Immunodeficiency Diseases; Myelodysplastic Syndromes; Hematologic Neoplasms; Anemia, Aplastic; Hemoglobinopathies; Severe Combined Immunodeficiency
• Other Study ID Numbers: EVAADE; ET 18-184 (Other Identifier: Sponsor ID)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No