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Clinical Trial NCT05379738 (APALLO) for Haematological Malignancy is recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy (APALLO) 75 At-Home
Clinical Trial NCT05379738 (APALLO) is an interventional study for Haematological Malignancy that is recruiting. It started on 10 June 2022 with plans to enroll 75 participants. Led by Centre Hospitalier Universitaire de Nice, it is expected to complete by 10 April 2028. The latest data from ClinicalTrials.gov was last updated on 30 January 2024.
Brief 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. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.
Official Title
APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies
Conditions
Haematological MalignancyOther Study IDs
- APALLO
- 21-PP-12
NCT ID Number
Start Date (Actual)
2022-06-10
Last Update Posted
2024-01-30
Completion Date (Estimated)
2028-04-10
Enrollment (Estimated)
75
Study Type
Interventional
PHASE
N/A
Status
Recruiting
Primary Purpose
Basic Science
Design Allocation
N/A
Interventional Model
Single Group
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
Experimentaladapted physical activity 6 sessions of physical activity | 6 sessions of adapted physical activity after stem cell transplant 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 |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
weight loss | Body weight n in kilograms | 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. | before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
patient's ability to attend the classes | number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility | 3 months after stem cell transplantation |
body mass index | Measure of weight and height to evaluate the nutriotional status of a patient | 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 | before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation |
grip strength evaluation | it is a measure of muscular strength | 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) | 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 | 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) | before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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
- 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
Centre Hospitalier Universitaire de NiceStudy Central Contact
Contact: SOLDATI Alizée, 04 92 03 96 27, [email protected]
Contact: LOSCHI Mickael, MD, 04 92 03 90 25
1 Study Locations in 1 Countries
CHU NICE, hopital ARCHET 1, hématologie, Nice, France
SOLDATI Alizée, Contact
Recruiting