Acute LeukemiaKinHémoNCT04899882
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.
A study testing KinHémo in people with Acute Leukemia, run by University Hospital, Angers at 4 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Leukemia
- What is being tested?
- KinHémo
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 4 sitesFrance
- Study dates
- 5 Jan 2022to 5 Mar 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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.
Trial locations and contacts
4 sites in 1 country.
France4 sites, 4 recruiting
- Recruiting
CHU Angers
Angers, 49933
Maria LUBI-LEON
- Recruiting
CHU Brest
Brest
Gaëlle GUILLERM, Dr
- Recruiting
CHU Nantes
Nantes
Anne LOK, Dr
- Recruiting
CHU Tours
Tours
Emmanuel GYAN, Pr
About this study
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)
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
- Acute Leukemia
- Being tested
- KinHémo
- Keywords
- sarcopenia, exercise, cancer related fatigue
- Medical subject headings
- Sarcopenia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinHémoOther
Evaluation and cardiovascular training, combination of resistance and flexibility training
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | Not described |
| KinHémo group | Experimental | Not described Receives: Other: KinHémo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Evolution of Short Physical Performance Battery measurements,
Measured: 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
Evolution of muscle mass by Bioelectrical impedance analysis
Measured: 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
Assessment of anxiety and depressive disorders
Measured: 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
Treatment of Cancer-Quality of Life Questionnaire-30 were used as measures of quality of life of cancer patients
Measured: 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
Evolution of muscle strength by measuring grip strength by dynamometer, evolution of the muscle strength of the lower limbs by standing up test chair
Measured: 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
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).
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2021
- Study start5 Jan 2022
- Primary completion5 Jan 2025 (estimated)
- Study completion5 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute LeukemiaStudies of the same condition, open and under way.
- More trials run by University Hospital, AngersThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Angers
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04899882
- Sponsor's protocol ID
- 49RC20_0030
- Acronym
- KinHémo
- Status last verified
- Nov 2022
- First submitted
- 19 May 2021
- Last updated
- 7 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT04899882
- Acronym / sponsor ID
- KinHémo / 49RC20_0030
- Conditions
- Acute Leukemia
- Keywords
- sarcopenia, exercise, cancer related fatigue
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- University Hospital, AngersOther government
- Study start
- 5 Jan 2022 (actual)
- Primary completion
- 5 Jan 2025 (estimated)
- Study completion
- 5 Mar 2025 (estimated)
- First posted
- 25 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | – |
| KinHémo group | Experimental | Other: KinHémo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinHémoEvaluation and cardiovascular training, combination of resistance and flexibility training | Other | KinHémo group |
Primary outcome
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.
6 secondary outcomes
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
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
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
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
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
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing KinHémo in people with Acute Leukemia, run by University Hospital, Angers at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Maria LUBI LEON (+33 6.67.94.14.68, Maria.LubiLeon@chu-angers.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome 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 (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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2022.