Clinical trial NCT06026046: Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients
Official title: Feasibility of an Adapted Sports Program Based on Fencing to Reduce Physical Deconditioning in Adult Hematology Patients Receiving Intensive Treatment
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Leukemia
Lymphoma
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2023-09-06
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Proportion of patients attending at least 50% of the schedulded lessons over the entire duration of the program
timeFrame: 1 year
Secondary outcomes:
measure: Number of actual fencing lessons compared to number of scheduled fencing lessons
timeFrame: 1 year
measure: Average duration of fencing lessons
timeFrame: 1 year
measure: Average duration of the program
timeFrame: 1 year
measure: Typology of patients attending at least 50% of the scheduled fencing lessons over the entire duration of the program
timeFrame: 1 year
measure: 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
timeFrame: 1 year
measure: Evolution of the distance covered in 6-minute walk test between inclusion and 6-month follow-up
timeFrame: 6 months
measure: Evolution of the SPPB (Short Physical Performance Battery) score between inclusion and 6-month follow-up
timeFrame: 6 months
measure: Evolution of the upper limb grip strength measured by dynamometer between inclusion and 6-month follow-up
timeFrame: 6 months
Other outcomes:
Locations:
city: Angers
country: France
facility: University Hospital, Angers
city: Brest
country: France
facility: University Brest Hopspital
Study officials:
affiliation: University Hospital, Angers
name: Aline MD Schmidt, PHD
role: PRINCIPAL_INVESTIGATOR
References: