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. (KinHémo)

University Hospital, Angers

Status

Enrolling

Conditions

Acute Leukemia

Treatments

Other: KinHémo

Study type

Interventional

Funder types

Other

Identifiers

NCT04899882

49RC20_0030

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.