LeukemiaEscrimHEMANCT06026046
Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients
A study testing Adapted sport program based on fencing in people with Leukemia and Lymphoma, run by University Hospital, Angers at 2 sites in France.
Trial summary
In 20 years, the prognosis of hematology patients has improved thanks to the development and adaptation of treatments and better risk management. However, medium and long-term complications of intensive treatments are common and remain a real public health problem. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Adapted sport program based on fencing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 2 sitesFrance
- Study dates
- 7 Dec 2023to 20 May 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patient admitted to a protected unit of the Hematology department of one of the participating centers
- Patient with acute leukemia treated in induction with "3+7" or "5+7" intensive treatment or by an equivalent treatment (Vyxeos, azacitidine+vénetoclax), or patient admitted for an allograft or CAR-T cells and not included at the diagnosis of the disease
- Patient eligible for intensive chemotherapy
- Patient requiring prolonged hospitalization with room confinement
- Signed informed consent form
Who cannot join
- Patient with a neurological or cardiac disease that contraindicates the practice of fencing
- No intensive treatment with prolonged hospitalization
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
- Person under legal protection
- Person unable to express consent
- Person not covered by or not benefiting from a social security system
Trial locations and contacts
2 sites in 1 country.
France2 sites
University Hospital, Angers
Angers, 49000
University Brest Hopspital
Brest, 29609
About this study
Official title: Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment
In 20 years, the prognosis of hematology patients has improved thanks to the development and adaptation of treatments and better risk management. However, medium and long-term complications of intensive treatments are common and remain a real public health problem. Indeed, intensive treatments associated with room confinement within a protected unit expose patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this deconditioning is neglected, response to treatment, tolerance, quality of life and, in the longer term, survival will be impacted.
Several teams have demonstrated the feasibility and the benefits of physical support for patients with prolonged aplasia. These studies focused on peripheral stem cell allograft, which occur late in the treatment of acute leukemia. On the other hand, studies evaluating the benefits of physical support as soon as the diagnosis of acute leukemia is made and intensive treatments are started are rare. Implementing a adapted sport program from the diagnostic and throughout the course of treatment is therefore a worthwhile subject for research.
Read more
The adapted sport chosen was fencing because it responds to hematological problems. Fencing is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair or in bed, involves praxis and concentration, and involves the whole body. It can be practiced individually or as part of a team, in a protected room or in a unit corridor. Fencing is a fighting sport and includes a psychological aspect, with a possible projection of a fight against the disease. In addition, fencing is carried out by a non-medical or paramedical practitioner, which can reinforce or recreate an image of normal activity. Finally, the attention required by listening to the fencing master and the necessary concentration unconsciously pushes the patient to "get out of his illness".
The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an adapted sport program based on fencing in adult patients with hematological malignancies receiving intensive treatment, to reduce physical deconditioning.
- Being tested
- Adapted sport program based on fencing
- Medical subject headings
- Leukemia, Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted sport program based on fencingOther
This adapted sport program includes 3 to 5 sessions per week of adapted fencing (excluding weekends and public holidays), carried out either by a fencing master trained in adapted sport, or by an APA teacher trained in adapted fencing by the fencing master.
Sessions can last from 10 to 30 minutes. The course of the session is validated by the fencing master and adapted to each patient. The limiting factors are taken into account, in order to direct towards a specific practice.
The sessions are progressive with very short and varied sequences calling on the imagination and experience of the fencing masters.
| Study group | Role | What they receive |
|---|---|---|
| Patients benefiting from the adapted sport program based on fencing | Experimental | Not described Receives: Other: Adapted sport program based on fencing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
The proportion of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program will be used to evaluate the feasibility of the adapted sport program based on fencing.
Measured: 1 year
Secondary outcomes (8)
Number of actual fencing lessons compared to number of scheduled fencing lessons
The comparison between the number of fencing lessons patients actually attended and the number of fencing lessons theoretically planned will be used to assess adherence to the adapted sport program.
Measured: 1 year
Average duration of fencing lessons
The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .
Measured: 1 year
Average duration of the program
The average duration of the program corresponds to the average duration of the adapted sport program for each participant in real-life conditions. It will be used to assess the adequacy of the theoretical modalities and the implementation of the program in real-life conditions .
Measured: 1 year
Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program
The typology of patients will be described according to pathology, age, co-morbidities, type of intensive chemotherapy, treatment phase (induction, consolidation, allograft, CAR-T cells)
Measured: 1 year
Comparison between the EORTC-QLQC30 score obtained at inclusion and the score obtained at each prolonged hospitalization discharge and at 3 months, 6 months and 1
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 is used to assess the quality of life.
The European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire for Cancer - C30 comprises 30 items. The 28 first items are constructed on a Likert scale with 4 response modalities (1 "Not at all" / 2 "A little" / 3 "Quite a lot" / 4 "A lot"), the modality 4 representing a high level of symptomatology / problems. The last two items are constructed on a 7-modality scale. These two items respectively assess overall health and overall quality of life, with response modality 1 corresponding to a "very poor" state, and response modality 7 to an "excellent" state.
Measured: 1 year
Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up
The 6-minute walk test is used to assess functional exercise capacity of an individual. It measures the distance an individual is able to walk over a 6-minute period.
Measured: 6 months
Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up
The SPPB test is used to assess the physical performance of an individual. Il is the result of the scores of three criteria: the balance test, the walking speed test and the sit-to-stand test. The sum of the scores of all the tests gives an overall performance score.
Measured: 6 months
Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up
This test is used to measure muscle strength in the hand and forearm.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start7 Dec 2023
- Primary completion30 May 2025
- Study completion20 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Aline MD Schmidt, PHD, Principal investigator, University Hospital, Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06026046
- Sponsor's protocol ID
- 49RC23_0088
- Other IDs
- 2023-A01596-39
- Acronym
- EscrimHEMA
- Status last verified
- May 2026
- First submitted
- 28 Aug 2023
- Last updated
- 28 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment
- ClinicalTrials.gov ID
- NCT06026046
- Acronym / sponsor ID
- EscrimHEMA / 49RC23_0088
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 7 Dec 2023 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 6 Sep 2023 (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.
In 20 years, the prognosis of hematology patients has improved thanks to the development and adaptation of treatments and better risk management. However, medium and long-term complications of intensive treatments are common and remain a real public health problem. Indeed, intensive treatments associated with room confinement within a protected unit expose patients to physical deconditioning of multifactorial pathophysiological mechanisms. If this deconditioning is neglected, response to treatment, tolerance, quality of life and, in the longer term, survival will be impacted.
Several teams have demonstrated the feasibility and the benefits of physical support for patients with prolonged aplasia. These studies focused on peripheral stem cell allograft, which occur late in the treatment of acute leukemia. On the other hand, studies evaluating the benefits of physical support as soon as the diagnosis of acute leukemia is made and intensive treatments are started are rare. Implementing a adapted sport program from the diagnostic and throughout the course of treatment is therefore a worthwhile subject for research.
The adapted sport chosen was fencing because it responds to hematological problems. Fencing is adaptable without carrying or receiving blow, can be practiced standing up, in an armchair or in bed, involves praxis and concentration, and involves the whole body. It can be practiced individually or as part of a team, in a protected room or in a unit corridor. Fencing is a fighting sport and includes a psychological aspect, with a possible projection of a fight against the disease. In addition, fencing is carried out by a non-medical or paramedical practitioner, which can reinforce or recreate an image of normal activity. Finally, the attention required by listening to the fencing master and the necessary concentration unconsciously pushes the patient to "get out of his illness".
The aim of this pilot study is to assess the feasibility, throughout the care pathway, of an adapted sport program based on fencing in adult patients with hematological malignancies receiving intensive treatment, to reduce physical deconditioning.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients benefiting from the adapted sport program based on fencing | Experimental | Other: Adapted sport program based on fencing |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patient admitted to a protected unit of the Hematology department of one of the participating centers
- Patient with acute leukemia treated in induction with "3+7" or "5+7" intensive treatment or by an equivalent treatment (Vyxeos, azacitidine+vénetoclax), or patient admitted for an allograft or CAR-T cells and not included at the diagnosis of the disease
- Patient eligible for intensive chemotherapy
- Patient requiring prolonged hospitalization with room confinement
- Signed informed consent form
Key exclusion criteria (8 listed)
- Patient with a neurological or cardiac disease that contraindicates the practice of fencing
- No intensive treatment with prolonged hospitalization
- Pregnant, parturient or breastfeeding woman
- Person deprived of liberty by judicial or administrative decision
- Person under forced psychiatric care
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 |
|---|---|---|
| Adapted sport program based on fencingThis adapted sport program includes 3 to 5 sessions per week of adapted fencing (excluding weekends and public holidays), carried out either by a fencing master trained in adapted sport, or by an APA teacher trained in adapted fencing by the fencing master. Sessions can last from 10 to 30 minutes. The course of the session is validated by the fencing master and adapted to each patient. The limiting factors are taken into account, in order to direct towards a specific practice. The sessions are progressive with very short and varied sequences calling on the imagination and experience of the fencing masters. | Other | Patients benefiting from the adapted sport program based on fencing |
Primary outcome
Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
Time frame: 1 year
The proportion of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program will be used to evaluate the feasibility of the adapted sport program based on fencing.
8 secondary outcomes
Number of actual fencing lessons compared to number of scheduled fencing lessons
Time frame: 1 year
Average duration of fencing lessons
Time frame: 1 year
Average duration of the program
Time frame: 1 year
Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program
Time frame: 1 year
Comparison between the EORTC-QLQC30 score obtained at inclusion and the score obtained at each prolonged hospitalization discharge and at 3 months, 6 months and 1
Time frame: 1 year
Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up
Time frame: 6 months
Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up
Time frame: 6 months
Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up
Time frame: 6 months
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 28 May 2026.
- Individual participant dataSharing planned: Yes. Data will be shared upon reasonable request. Only de-identified data will be shared. Any data collected during the study may be shared. The protocol will be shared initially. Other documents may be shared at a later date upon request (e.g., the CRF to allow a collaborator to select the data they wish to access). The recipients of the data will be researchers. The data will be available for any purpose deemed relevant by the study investigator, based on a protocol provided by the requester, after verification of the obtaining of regulatory approvals, including the favorable opinion of an ethics committee.
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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.
Aline MD Schmidt, PHD principal investigator
University Hospital, Angers
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Adapted sport program based on fencing in people with Leukemia and Lymphoma, run by University Hospital, Angers at 2 sites 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 5 inclusion and 8 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 28 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program (time frame: 1 year). 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 May 2026.