Clinical trial · Interventional
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.
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)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| KinHémo | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Control group
- type
- EXPERIMENTAL
- label
- KinHémo group
- interventionNames
- Other: KinHémo
Primary outcomes (1)
- 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
- description
- 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.
Secondary outcomes (6)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
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