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Physical Fitness Impact of Early Physiotherapy Intervention With a Standardized Exercise Therapy Program in Adult Patients Receiving Intensive Induction Chemotherapy for Treatment of Acute Leukemia During Extended Hospitalization.

Recruiting
18 years of age
Both
Phase N/A

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Overview

This study aimed to investigate the impact of Physical therapy in adult patients receiving intensive induction chemotherapy for the treatment of acute leukemia during prolonged hospitalization. The study cohort included 150 patients. Primary objective is to compare the effect of a standardized rehabilitation program on physical deconditioning. This study has several secondary objectives of comparing and analyzing the status of sarcopenia, muscle strength, physical performance and the psychic dimension of this intervention. The 6 minutes walking test, Handgrip strength, impedance measurement, computed tomography, Short Physical Performance were used as measures of physical function. Hospital Anxiety and Depression Scale and European Organization for the Research and Treatment of Cancer-Quality of Life-Questionnaire-30 (EORTC-QLQ-30) were used as measures of depression and anxiety and quality of life of cancer patients. To investigate the impact of physical therapy, patients were assigned to the physical therapy group (experimental group) or the control group.These results will thus make it possible to promote access to physiotherapy and rehabilitation care, from diagnosis and during hospitalization, and to standardize practices.

Eligibility

Inclusion Criteria:

  • Adult patient >18 years
  • Patient with acute leukemia eligible to receive intensive chemotherapy (induction phase) with predictable deep bone marrow aplasia (polynuclear neutrophils <500mm3 for more than 8 days) requiring prolonged hospitalization with room confinement.
  • Patient having signed the informed consent to participate in the study

Exclusion Criteria:

  • Patient with disabilities or contraindications (significant cognitive or psychiatric disorders, significant cardiac or pulmonary pathology, neurological, joint, orthopedic or medical condition, etc.) following an exercise therapy program and carrying out follow-up defined by the protocol and in particular the physical performance tests.
  • Active bleeding, acute thrombosis, ischemia, hemodynamic instability or uncontrolled pain
  • No understanding of the French language
  • Pregnant women, parturients and nursing mothers
  • Persons deprived of their liberty by judicial or administrative decision
  • People under duress psychiatric care
  • Persons subject to legal protection
  • Persons unable to express their consent
  • Person not affiliated to a health insurance scheme or not beneficiary of a social security scheme.

Study details

Acute Leukemia

NCT04899882

University Hospital, Angers

25 January 2024

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