Haematological MalignancyEVAADENCT04331483
A Study to Assess a Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Allografts
A study testing Physical activity program in people with Haematological Malignancy and Acute Leukemia, run by Centre Leon Berard at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 8 to 21 years
- Conditions the study is for
- Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes
- What is being tested?
- Physical activity program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteFrance
- Study dates
- 8 Dec 2018to Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Severe Heart Disease and Uncontrolled Cardiovascular Disease
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
- Conditions
- Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes, Hemoglobinopathy in Children, Bone Marrow Aplasia, Severe Combined Immunodeficiency
- Being tested
- Physical activity program
- Medical subject headings
- Hematologic Neoplasms, Myelodysplastic Syndromes, Anemia, Aplastic, Severe Combined Immunodeficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical activity programOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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). Receives: Other: Physical activity program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: weekly from baseline to 3 months
Secondary outcomes (11)
Impact of the physical activity program on weight
weight in kgs
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on waist circumference
assessed in cm
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on hip circumference
assessed in cm
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on abdominal circumference
assessed in cm
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on body mass index
weight/(size)2
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on endurance capacity
Harvard step test
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on muscle strength
Dynamometer
Measured: Baseline, 1 month and 3 months
Impact of the physical activity program on fatigue
Visual analogic scale from 0 to 10
Measured: Baseline, 1 month and 3 months
Self-efficacy feeling
HAPA questionnaire
Measured: 3 months
Motivation towards physical activity
BREQ questionnaire
Measured: Baseline, 1 month and 3 months
Impact of the PA program on metabolic syndrome
Lipid check-up
Measured: Baseline and 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2020
- Study start8 Dec 2018
- Primary completionSep 2023 (estimated)
- Study completionSep 2023 (estimated)
Why it stopped: modification of the intervention before patient's enrollment, new protocol submitted
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carine HALFON-DOMENECH, MD, Principal investigator, Institut d'Hematologie et d'Oncologie Pédiatrique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04331483
- Sponsor's protocol ID
- EVAADE
- Other IDs
- ET 18-184
- Acronym
- EVAADE
- Status last verified
- Feb 2022
- First submitted
- 31 Mar 2020
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04331483
- Acronym / sponsor ID
- EVAADE / EVAADE
- Conditions
- Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes, Hemoglobinopathy in Children, Bone Marrow Aplasia, Severe Combined Immunodeficiency
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: modification of the intervention before patient's enrollment, new protocol submitted
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 8 Dec 2018 (actual)
- Primary completion
- Sep 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 2 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Physical activity intervention | Experimental | Other: Physical activity programThe 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). |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (1 listed)
- Severe Heart Disease and Uncontrolled Cardiovascular Disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical activity programSupervised 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. | Other | Physical activity intervention |
Primary outcome
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
11 secondary outcomes
Impact of the physical activity program on weight
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on waist circumference
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on hip circumference
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on abdominal circumference
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on body mass index
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on endurance capacity
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on muscle strength
Time frame: Baseline, 1 month and 3 months
Impact of the physical activity program on fatigue
Time frame: Baseline, 1 month and 3 months
Self-efficacy feeling
Time frame: 3 months
Motivation towards physical activity
Time frame: Baseline, 1 month and 3 months
Impact of the PA program on metabolic syndrome
Time frame: Baseline and 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carine HALFON-DOMENECH, MD principal investigator
Institut d'Hematologie et d'Oncologie Pédiatrique
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical activity program in people with Haematological Malignancy and Acute Leukemia, run by Centre Leon Berard at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Observance to the physical activity program (time frame: weekly from baseline to 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Feb 2022.