Haematological MalignancyAPALLONCT05379738
Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy
A study testing 6 sessions of adapted physical activity after stem cell transplant in people with Haematological Malignancy, run by Centre Hospitalier Universitaire de Nice at 1 site in France.
Trial summary
It is a study about adaptated physical activity for patients receiving a stem cell transplantation. They will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Haematological Malignancy
- What is being tested?
- 6 sessions of adapted physical activity after stem cell transplant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jun 2022to 10 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient aged 18 or more
- Patient with social security
- Patient who accept the study and sign the consent form
- Patient programmed for an allogenic stem cell transplantation
- Non inclusion criteria :
- Patients with a guardianship
- Patients with a significant additional physic or mental disease
Who cannot join
- Patients who did not receive an allogeniac stem cell transplantation
- Patients still hospitalized between day 30 and day 100 after stem cell transplantation
- Patients who finally refuses the study
- Patients who develop a physical or mental incapacity to practice physical activity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
LOSCHI Mickael, MD contact
France1 site, 1 recruiting
- Recruiting
CHU NICE, hopital ARCHET 1, hématologie
Nice
SOLDATI Alizée
About this study
Official title: APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies
It is a study about adaptated physical activity for patients receiving a stem cell transplantation. They will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.
- Conditions
- Haematological Malignancy
- Being tested
- 6 sessions of adapted physical activity after stem cell transplant
- Medical subject headings
- Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
6 sessions of adapted physical activity after stem cell transplantOther
physical assessement before and after stem cell transplant:
- weight loss
- brachial muscle circumference
- grip strength evaluation
- short physical battery test psychometric assessment before and after stem cell transplant:
- quality of life questionary
- physical activities questionary
| Study group | Role | What they receive |
|---|---|---|
| adapted physical activity | Experimental | 6 sessions of physical activity Receives: Other: 6 sessions of adapted physical activity after stem cell transplant |
What is being measured
The primary outcome is the main question the study is designed to answer.
weight loss
Body weight n in kilograms
Measured: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
weight loss
Calculation of the percent of body weight loss between the " before stem cell transplantation evaluation " and each evaluation after stem cell transplantation and after adaptated physical activity sessions.
Measured: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Secondary outcomes (7)
patient's ability to attend the classes
number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility
Measured: 3 months after stem cell transplantation
body mass index
Measure of weight and height to evaluate the nutriotional status of a patient
Measured: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
brachial muscle circumference
evaluation in centimeters of the brachial circumference to evaluate the evolution of the muscle circumference after stem cell transplantation and adaptated physical activity compared to the evaluation before stem cell transplantation. Using a measuring tape
Measured: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
grip strength evaluation
it is a measure of muscular strength
Measured: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
short physical battery test
it is a series of 3 physical tests to evaluate mobility the first test is a balance test (4 points), the second test is an evaluation of a walking speed (4 points) and the third test is a Chair rise test (4 points) The global test is on 12 points (12 is the better score)
Measured: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Quality of Life Questionary C30 (QLQ-C30)
it is a score to evaluate the quality of life of patients facing illness The subscales scores are transformed to a 0 to 100 scale, with higher score on functionnal scales indicating better function and higher scores on sumptom scales indicating worse symptoms
Measured: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
in house developped physical activities questionary
it is a questionnary created especially for this study to evaluate on each step the capacity of each patient to maintain physical activities (social activities, autonomy at home for cooking and hygiene care, autonomy for transport to go to hospital appointments)
Measured: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2022
- Study start10 Jun 2022
- Primary completion10 Dec 2026 (estimated)
- Study completion10 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Haematological MalignancyStudies of the same condition, open and under way.
- 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
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- SOLDATI Alizée, Principal investigator, CHU NICE, hopital ARCHET 1, hématologie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05379738
- Sponsor's protocol ID
- 21-PP-12
- Acronym
- APALLO
- Status last verified
- Jan 2024
- First submitted
- 9 May 2022
- Last updated
- 30 Jan 2024
- 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 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies
- ClinicalTrials.gov ID
- NCT05379738
- Acronym / sponsor ID
- APALLO / 21-PP-12
- Conditions
- Haematological Malignancy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- 10 Dec 2026 (estimated)
- Study completion
- 10 Apr 2028 (estimated)
- First posted
- 18 May 2022 (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.
It is a study about adaptated physical activity for patients receiving a stem cell transplantation. They will benefit of 6 adaptated individuals lessons at home between 1 month and 3 months after stem cell transplantation. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adapted physical activity | Experimental | Other: 6 sessions of adapted physical activity after stem cell transplant6 sessions of physical activity |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient aged 18 or more
- Patient with social security
- Patient who accept the study and sign the consent form
- Patient programmed for an allogenic stem cell transplantation
- Patients with a guardianship
Key exclusion criteria (4 listed)
- Patients who did not receive an allogeniac stem cell transplantation
- Patients still hospitalized between day 30 and day 100 after stem cell transplantation
- Patients who finally refuses the study
- Patients who develop a physical or mental incapacity to practice physical activity
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 |
|---|---|---|
| 6 sessions of adapted physical activity after stem cell transplantphysical assessement before and after stem cell transplant: * weight loss * brachial muscle circumference * grip strength evaluation * short physical battery test psychometric assessment before and after stem cell transplant: * quality of life questionary * physical activities questionary | Other | adapted physical activity |
Primary outcome
weight loss
Time frame: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Body weight n in kilograms
weight loss
Time frame: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Calculation of the percent of body weight loss between the " before stem cell transplantation evaluation " and each evaluation after stem cell transplantation and after adaptated physical activity sessions.
7 secondary outcomes
patient's ability to attend the classes
Time frame: 3 months after stem cell transplantation
body mass index
Time frame: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
brachial muscle circumference
Time frame: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
grip strength evaluation
Time frame: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
short physical battery test
Time frame: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Quality of Life Questionary C30 (QLQ-C30)
Time frame: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
in house developped physical activities questionary
Time frame: before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
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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.
LOSCHI Mickael, MD contact
SOLDATI Alizée principal investigator
CHU NICE, hopital ARCHET 1, hématologie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 6 sessions of adapted physical activity after stem cell transplant in people with Haematological Malignancy, run by Centre Hospitalier Universitaire de Nice at 1 site 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 7 inclusion and 4 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: looking for participants now, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact SOLDATI Alizée (04 92 03 96 27, soldati.a@chu-nice.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weight loss (time frame: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation). The study lists 2 primary outcomes in all. 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 30 Jan 2024.