Haematological MalignancyEVAADENCT05298930
Feasibility Study to Assess an Adapted Physical Activity Program in Children, Adolescents and Young Adults Requiring Hematopoietic Stem Cell Transplantation
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
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). Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- 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
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 25 May 2022to 31 Jul 2024
- 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
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Show all 14Show fewer
- 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)
- 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).
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read more
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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Physical activity intervention | Experimental | 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. 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 (achieved meaning the patient attended at least one session of 15 minutes weekly during the whole program, considering both supervised and unsupervised sessions)
Measured: 3 months
Secondary outcomes (14)
Impact of unsupervised sessions on patients' PA practice
Rate of unsupervised sessions/total of performed sessions
Measured: baseline, 3 months
Impact of the physical activity program on weight
weight in kgs
Measured: baseline, 3 months
Impact of the physical activity on waist circumference
waist circumference assessed in cm
Measured: baseline, 3 months
Impact of the physical activity program on hip circumference
hip circumference assessed in cm
Measured: baseline, 3 months
Impact of the physical activity program on body mass index
weight/(size)^2
Measured: baseline, 3 months
Impact of the physical activity program on endurance capacity
Harvard step test
Measured: baseline, 3 months
Impact of the physical activity program on muscle strength
Dynanometer
Measured: baseline, 3 months
Impact of the physical activity program on fatigue
Visual analogic scale from 0 to 10
Measured: baseline, 3 months
Self efficacy feeling
HAPA questionnaire
Measured: 3 months
Motivation towards physical activity
BREQ-2 questionnaire
Measured: baseline, 3 months
Impact of the PA program on metabolic syndrome
Lipid check-up
Measured: baseline, 3 months
Impact of social environment of PA practice
PA practice of patient / PA practice of relatives
Measured: 3 months
Overall satisfaction
Likert-scale questionnaire
Measured: 3 months
Acceptability of the intervention
Number of enrolled patients/number of eligible patients
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2022
- Study start25 May 2022
- Primary completion31 Jul 2024
- Study completion31 Jul 2024
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
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Leon Berard
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05298930
- Sponsor's protocol ID
- EVAADE ET 21-015
- Acronym
- EVAADE
- Status last verified
- Aug 2023
- First submitted
- 3 Mar 2022
- Last updated
- 21 Aug 2024
- 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 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05298930
- Acronym / sponsor ID
- EVAADE / EVAADE ET 21-015
- Conditions
- Haematological Malignancy, Acute Leukemia, Myelodysplastic Syndromes, Hemoglobinopathy in Children, Bone Marrow Aplasia, Severe Combined Immunodeficiency
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Leon BerardUniversity, hospital or other
- Study start
- 25 May 2022 (actual)
- Primary completion
- 31 Jul 2024 (actual)
- Study completion
- 31 Jul 2024 (actual)
- First posted
- 28 Mar 2022 (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.
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.
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 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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (14 listed)
- 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
Key exclusion criteria (4 listed)
- 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).
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 programThe 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. | Other | Physical activity intervention |
Primary outcome
observance to the physical activity program
Time frame: 3 months
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)
14 secondary outcomes
Impact of unsupervised sessions on patients' PA practice
Time frame: baseline, 3 months
Impact of the physical activity program on weight
Time frame: baseline, 3 months
Impact of the physical activity on waist circumference
Time frame: baseline, 3 months
Impact of the physical activity program on hip circumference
Time frame: baseline, 3 months
Impact of the physical activity program on body mass index
Time frame: baseline, 3 months
Impact of the physical activity program on endurance capacity
Time frame: baseline, 3 months
Impact of the physical activity program on muscle strength
Time frame: baseline, 3 months
Impact of the physical activity program on fatigue
Time frame: baseline, 3 months
Self efficacy feeling
Time frame: 3 months
Motivation towards physical activity
Time frame: baseline, 3 months
Impact of the PA program on metabolic syndrome
Time frame: baseline, 3 months
Impact of social environment of PA practice
Time frame: 3 months
Overall satisfaction
Time frame: 3 months
Acceptability of the intervention
Time frame: baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 14 inclusion and 4 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: finished, as of the sponsor's last update on 21 Aug 2024. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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: 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 21 Aug 2024.