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
1 other identifier
interventional
150
1 country
4
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2022
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 19, 2021
CompletedFirst Posted
Study publicly available on registry
May 25, 2021
CompletedStudy Start
First participant enrolled
January 5, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 5, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
March 5, 2025
CompletedNovember 7, 2022
November 1, 2022
3 years
May 19, 2021
November 2, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
The physical performance assessed with Evolution of Short Physical Performance Battery
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
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
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
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
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
- +1 more secondary outcomes
Study Arms (2)
Control group
NO INTERVENTIONKinHémo group
EXPERIMENTALInterventions
Evaluation and cardiovascular training, combination of resistance and flexibility training
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
CHU Angers
Angers, 49933, France
CHU Brest
Brest, France
CHU Nantes
Nantes, France
CHU Tours
Tours, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 19, 2021
First Posted
May 25, 2021
Study Start
January 5, 2022
Primary Completion
January 5, 2025
Study Completion
March 5, 2025
Last Updated
November 7, 2022
Record last verified: 2022-11