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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04331483
Recruitment Status : Active, not recruiting
First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Centre Leon Berard

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.


Condition or disease Intervention/treatment Phase
Haematological Malignancy Acute Leukemia Myelodysplastic Syndromes Hemoglobinopathy in Children Bone Marrow Aplasia Severe Combined Immunodeficiency Other: Physical activity program Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Actual Study Start Date : December 8, 2018
Estimated Primary Completion Date : September 2023
Estimated Study Completion Date : September 2023


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.





Primary Outcome Measures :
  1. Observance to the physical activity program [ Time Frame: weekly from baseline to 3 months ]
    achieved/non-achieved (achived meaning the patient attended at least one session of 15 minutes weekly during the whole program


Secondary Outcome Measures :
  1. Impact of the physical activity program on weight [ Time Frame: Baseline, 1 month and 3 months ]
    weight in kgs

  2. Impact of the physical activity program on waist circumference [ Time Frame: Baseline, 1 month and 3 months ]
    assessed in cm

  3. Impact of the physical activity program on hip circumference [ Time Frame: Baseline, 1 month and 3 months ]
    assessed in cm

  4. Impact of the physical activity program on abdominal circumference [ Time Frame: Baseline, 1 month and 3 months ]
    assessed in cm

  5. Impact of the physical activity program on body mass index [ Time Frame: Baseline, 1 month and 3 months ]
    weight/(size)2

  6. Impact of the physical activity program on endurance capacity [ Time Frame: Baseline, 1 month and 3 months ]
    Harvard step test

  7. Impact of the physical activity program on muscle strength [ Time Frame: Baseline, 1 month and 3 months ]
    Dynamometer

  8. Impact of the physical activity program on fatigue [ Time Frame: Baseline, 1 month and 3 months ]
    Visual analogic scale from 0 to 10

  9. Self-efficacy feeling [ Time Frame: 3 months ]
    HAPA questionnaire

  10. Motivation towards physical activity [ Time Frame: Baseline, 1 month and 3 months ]
    BREQ questionnaire

  11. Impact of the PA program on metabolic syndrome [ Time Frame: Baseline and 3 months ]
    Lipid check-up



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Ages Eligible for Study:   8 Years to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04331483


Locations
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France
Institut d'Hématologie et d'Oncologie Pédiatrique
Lyon, France, 69008
Sponsors and Collaborators
Centre Leon Berard
Investigators
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Principal Investigator: Carine HALFON-DOMENECH, MD Institut d'Hematologie et d'Oncologie Pédiatrique

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Responsible Party: Centre Leon Berard
ClinicalTrials.gov Identifier: NCT04331483    
Other Study ID Numbers: EVAADE
ET18-184 ( Other Identifier: Sponsor ID )
First Posted: April 2, 2020    Key Record Dates
Last Update Posted: April 2, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hematologic Neoplasms
Myelodysplastic Syndromes
Hemoglobinopathies
Anemia, Aplastic
Severe Combined Immunodeficiency
Neoplasms
Bone Marrow Diseases
Hematologic Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Genetic Diseases, Inborn
Infant, Newborn, Diseases
DNA Repair-Deficiency Disorders
Metabolic Diseases
Neoplasms by Site
Anemia