Clinical trial NCT04899882: 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.
Official title: 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)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Acute Leukemia
Keywords: sarcopenia
exercise
cancer related fatigue
Lead sponsor: University Hospital, Angers
Sponsor class: OTHER_GOV
First posted: 2021-05-25
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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 criteria: 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.

Primary outcomes:
measure: 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
timeFrame: 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 outcomes:
measure: The physical performance assessed with Evolution of Short Physical Performance Battery
timeFrame: 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
measure: The muscle mass assessed with Bioelectrical impedance analysis
timeFrame: 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
measure: Anxiety and Depressive Disorders assessed with the Hospital Anxiety and Depression Scale
timeFrame: Hospital Anxiety and Depression Scale and European Organization for the Research
measure: Evolution of activities of daily living assessed with Treatment of Cancer-Quality of Life Questionnaire-30
timeFrame: The comparison visit 0 versus Visit 1 bis 10 to 15 days after discharge from hospital for induction
measure: muscle strength assessed with dynamometer and standing up test chair
timeFrame: 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
measure: Rate of patients with at least one complication
timeFrame: 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
Other outcomes:
Locations:
city: Angers
country: France
facility: CHU Angers
city: Brest
country: France
facility: CHU Brest
city: Nantes
country: France
facility: CHU Nantes
city: Tours
country: France
facility: CHU Tours
Study officials:
References: