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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)

Primary Purpose

Acute Leukemia

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
KinHémo
Sponsored by
University Hospital, Angers
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Leukemia focused on measuring sarcopenia, exercise, cancer related fatigue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • CHU AngersRecruiting
  • CHU BrestRecruiting
  • CHU NantesRecruiting
  • CHU ToursRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control group

KinHémo group

Arm Description

Outcomes

Primary Outcome Measures

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

The physical performance assessed with Evolution of Short Physical Performance Battery
Evolution of Short Physical Performance Battery measurements,
The muscle mass assessed with Bioelectrical impedance analysis
Evolution of muscle mass by Bioelectrical impedance analysis
Anxiety and Depressive Disorders assessed with the Hospital Anxiety and Depression Scale
Assessment of anxiety and depressive disorders
Evolution of activities of daily living assessed with Treatment of Cancer-Quality of Life Questionnaire-30
Treatment of Cancer-Quality of Life Questionnaire-30 were used as measures of quality of life of cancer patients
muscle strength assessed with dynamometer and standing up test chair
Evolution of muscle strength by measuring grip strength by dynamometer, evolution of the muscle strength of the lower limbs by standing up test chair
Rate of patients with at least one complication
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).

Full Information

First Posted
May 19, 2021
Last Updated
November 2, 2022
Sponsor
University Hospital, Angers
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1. Study Identification

Unique Protocol Identification Number
NCT04899882
Brief 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.
Acronym
KinHémo
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

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 5, 2022 (Actual)
Primary Completion Date
January 5, 2025 (Anticipated)
Study Completion Date
March 5, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Angers

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Leukemia
Keywords
sarcopenia, exercise, cancer related fatigue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Title
KinHémo group
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
KinHémo
Intervention Description
Evaluation and cardiovascular training, combination of resistance and flexibility training
Primary Outcome Measure Information:
Title
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.
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
Secondary Outcome Measure Information:
Title
The physical performance assessed with Evolution of Short Physical Performance Battery
Description
Evolution of Short Physical Performance Battery measurements,
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
Title
The muscle mass assessed with Bioelectrical impedance analysis
Description
Evolution of muscle mass by 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
Title
Anxiety and Depressive Disorders assessed with the Hospital Anxiety and Depression Scale
Description
Assessment of anxiety and depressive disorders
Time Frame
Hospital Anxiety and Depression Scale and European Organization for the Research
Title
Evolution of activities of daily living assessed with Treatment of Cancer-Quality of Life Questionnaire-30
Description
Treatment of Cancer-Quality of Life Questionnaire-30 were used as measures of quality of life of cancer patients
Time Frame
The comparison visit 0 versus Visit 1 bis 10 to 15 days after discharge from hospital for induction
Title
muscle strength assessed with dynamometer and standing up test chair
Description
Evolution of muscle strength by measuring grip strength by dynamometer, evolution of the muscle strength of the lower limbs by 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
Title
Rate of patients with at least one complication
Description
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).
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maria LUBI LEON
Phone
+33 6.67.94.14.68
Email
Maria.LubiLeon@chu-angers.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Emma BLANCHET
Phone
+33 2 41 35 63 38
Email
EmBlanchet@chu-angers.fr
Facility Information:
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria LUBI-LEON
Facility Name
CHU Brest
City
Brest
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gaëlle GUILLERM, Dr
Facility Name
CHU Nantes
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne LOK, Dr
Facility Name
CHU Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emmanuel GYAN, Pr

12. IPD Sharing Statement

Learn more about this trial

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.

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