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.

NCT ID: NCT04899882

Last Updated: 2022-11-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-05

Study Completion Date

2025-03-05

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.

Detailed Description

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Conditions

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Acute Leukemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control group

Group Type NO_INTERVENTION

No interventions assigned to this group

KinHémo group

Group Type EXPERIMENTAL

KinHémo

Intervention Type OTHER

Evaluation and cardiovascular training, combination of resistance and flexibility training

Interventions

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KinHémo

Evaluation and cardiovascular training, combination of resistance and flexibility training

Intervention Type OTHER

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Angers

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Angers

Angers, , France

Site Status RECRUITING

CHU Brest

Brest, , France

Site Status RECRUITING

CHU Nantes

Nantes, , France

Site Status RECRUITING

CHU Tours

Tours, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Maria LUBI LEON

Role: CONTACT

+33 6.67.94.14.68

Emma BLANCHET

Role: CONTACT

+33 2 41 35 63 38

Facility Contacts

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Maria LUBI-LEON

Role: primary

Gaëlle GUILLERM, Dr

Role: primary

Anne LOK, Dr

Role: primary

Emmanuel GYAN, Pr

Role: primary

Other Identifiers

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49RC20_0030

Identifier Type: -

Identifier Source: org_study_id

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