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.

Study Overview
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Brief Summary
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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.

Official Title
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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. Randomized Controlled Superiority Trial in Parallel Arms, Multicentric (KinHémo)

Conditions
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Acute Leukemia

Intervention / Treatment
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* Other: KinHémo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control group<br> | |
| Experimental: KinHémo group<br> | Other: KinHémo<br>* Evaluation and cardiovascular training, combination of resistance and flexibility training<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity between V1 and V0 | The six-minute walk test (6MWT) measures the distance an individual is able to walk over a total of six minutes on a hard, flat surface. The goal is for the individual to walk as far as possible in six minutes. | The distance covered over a time of 6 minutes is used as the outcome by which to compare changes in performance capacity between V1 and V0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The physical performance assessed with Evolution of Short Physical Performance Battery | Evolution of Short Physical Performance Battery measurements, | The worsening rate of sarcopenia defined either by the occurrence of a status of sarcopenia regardless of the stage or by moving from one sarcopenia stage's to another, 4 to 6 week after hospitalization | 
| The muscle mass assessed with Bioelectrical impedance analysis | Evolution of muscle mass by Bioelectrical impedance analysis | The worsening rate of sarcopenia defined either by the occurrence of a status of sarcopenia regardless of the stage or by moving from one sarcopenia stage's to another, 4 to 6 week after hospitalization | 
| Anxiety and Depressive Disorders assessed with the Hospital Anxiety and Depression Scale | Assessment of anxiety and depressive disorders | Hospital Anxiety and Depression Scale and European Organization for the Research | 
| Evolution of activities of daily living assessed with Treatment of Cancer-Quality of Life Questionnaire-30 | Treatment of Cancer-Quality of Life Questionnaire-30 were used as measures of quality of life of cancer patients | The comparison visit 0 versus Visit 1 bis 10 to 15 days after discharge from hospital for induction | 
| muscle strength assessed with dynamometer and standing up test chair | Evolution of muscle strength by measuring grip strength by dynamometer, evolution of the muscle strength of the lower limbs by standing up test chair | The worsening rate of sarcopenia defined either by the occurrence of a status of sarcopenia regardless of the stage or by moving from one sarcopenia stage's to another, 4 to 6 week after hospitalization | 
| Rate of patients with at least one complication | The comparison of the effect of a standardized exercise therapy program versus practice current hospitalization for the induction phase of chemotherapy: Complications of all types (pressure sore, infection, stay in intensive care). | The rate of patients with at least one complication is used as the outcome by wich to compare of effect of a standardized exercise therapy program versus practice current after 4-6 weeks hospitalization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sarcopenia, exercise, cancer related fatigue