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Trial record 1 of 1 for:    NCT 04899882
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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. (KinHémo)

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ClinicalTrials.gov Identifier: NCT04899882
Recruitment Status : Recruiting
First Posted : May 25, 2021
Last Update Posted : November 7, 2022
Sponsor:
Information provided by (Responsible Party):
University Hospital, Angers

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Leukemia Other: KinHémo Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
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)
Actual Study Start Date : January 5, 2022
Estimated Primary Completion Date : January 5, 2025
Estimated Study Completion Date : March 5, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Leukemia

Arms and Interventions
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Arm Intervention/treatment
No Intervention: Control group
Experimental: KinHémo group Other: KinHémo
Evaluation and cardiovascular training, combination of resistance and flexibility training


Outcome Measures
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Primary Outcome Measures :
  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 [ 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.


Secondary Outcome Measures :
  1. The physical performance assessed with Evolution of Short Physical Performance Battery [ Time Frame: 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 ]
    Evolution of Short Physical Performance Battery measurements,

  2. The muscle mass assessed with Bioelectrical impedance analysis [ Time Frame: 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 ]
    Evolution of muscle mass by Bioelectrical impedance analysis

  3. Anxiety and Depressive Disorders assessed with the Hospital Anxiety and Depression Scale [ Time Frame: Hospital Anxiety and Depression Scale and European Organization for the Research ]
    Assessment of anxiety and depressive disorders

  4. Evolution of activities of daily living assessed with Treatment of Cancer-Quality of Life Questionnaire-30 [ Time Frame: The comparison visit 0 versus Visit 1 bis 10 to 15 days after discharge from hospital for induction ]
    Treatment of Cancer-Quality of Life Questionnaire-30 were used as measures of quality of life of cancer patients

  5. muscle strength assessed with dynamometer and standing up test chair [ Time Frame: 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 ]
    Evolution of muscle strength by measuring grip strength by dynamometer, evolution of the muscle strength of the lower limbs by standing up test chair

  6. Rate of patients with at least one complication [ Time Frame: 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 ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04899882


Contacts
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Contact: Maria LUBI LEON +33 6.67.94.14.68 Maria.LubiLeon@chu-angers.fr
Contact: Emma BLANCHET +33 2 41 35 63 38 EmBlanchet@chu-angers.fr

Locations
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France
CHU Angers Recruiting
Angers, France, 49933
Contact: Maria LUBI-LEON         
CHU Brest Recruiting
Brest, France
Contact: Gaëlle GUILLERM, Dr         
CHU Nantes Recruiting
Nantes, France
Contact: Anne LOK, Dr         
CHU Tours Recruiting
Tours, France
Contact: Emmanuel GYAN, Pr         
Sponsors and Collaborators
University Hospital, Angers
More Information
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Responsible Party: University Hospital, Angers
ClinicalTrials.gov Identifier: NCT04899882    
Other Study ID Numbers: 49RC20_0030
First Posted: May 25, 2021    Key Record Dates
Last Update Posted: November 7, 2022
Last Verified: November 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Hospital, Angers:
sarcopenia
exercise
cancer related fatigue
Additional relevant MeSH terms:
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Leukemia
Acute Disease
Neoplasms by Histologic Type
Neoplasms
 Hematologic Diseases
Disease Attributes
Pathologic Processes