Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients
EscrimHEMA
2 other identifiers
interventional
80
1 country
2
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable leukemia
Started Dec 2023
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 28, 2023
CompletedFirst Posted
Study publicly available on registry
September 6, 2023
CompletedStudy Start
First participant enrolled
December 7, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 30, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
June 13, 2026
ExpectedSeptember 19, 2025
September 1, 2025
1.5 years
August 28, 2023
September 15, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
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.
1 year
Secondary Outcomes (8)
Number of actual fencing lessons compared to number of scheduled fencing lessons
1 year
Average duration of fencing lessons
1 year
Average duration of the program
1 year
Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program
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
1 year
- +3 more secondary outcomes
Study Arms (1)
Patients benefiting from the adapted sport program based on fencing
EXPERIMENTALInterventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
University Hospital, Angers
Angers, 49000, France
University Brest Hopspital
Brest, 29609, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Aline MD Schmidt, PHD
University Hospital, Angers
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 28, 2023
First Posted
September 6, 2023
Study Start
December 7, 2023
Primary Completion
May 30, 2025
Study Completion (Estimated)
June 13, 2026
Last Updated
September 19, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL
- Time Frame
- The data will be shared after signing a negotiated data transfer agreement ( data access agreement), for the duration specified in the agreement.
- Access Criteria
- The data will be made available via secure transfer (sharing platform approved by the university hospital: BlueFiles or Oodrive).
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.