Back to resultsImpact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy (APALLO)
Primary Purpose
Haematological Malignancy
Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
6 sessions of adapted physical activity after stem cell transplant
Sponsored by
About this trial
This is an interventional basic science trial for Haematological Malignancy
Eligibility Criteria
Inclusion criteria :
- 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
Exclusion criteria
- 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
Sites / Locations
- CHU NICE, hopital ARCHET 1, hématologieRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
adapted physical activity
Arm Description
6 sessions of physical activity
Outcomes
Primary Outcome Measures
weight loss
Body weight n in kilograms
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.
Secondary Outcome Measures
patient's ability to attend the classes
number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility
body mass index
Measure of weight and height to evaluate the nutriotional status of a patient
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
grip strength evaluation
it is a measure of muscular strength
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)
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
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)
Full Information
NCT ID
NCT05379738
First Posted
May 9, 2022
Last Updated
June 13, 2022
Sponsor
Centre Hospitalier Universitaire de Nice
1. Study Identification
Unique Protocol Identification Number
NCT05379738
Brief Title
Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy
Acronym
APALLO
Official Title
APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 10, 2022 (Actual)
Primary Completion Date
June 1, 2025 (Anticipated)
Study Completion Date
June 1, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Nice
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
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Haematological Malignancy
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
adapted physical activity
Arm Type
Experimental
Arm Description
6 sessions of physical activity
Intervention Type
Other
Intervention Name(s)
6 sessions of adapted physical activity after stem cell transplant
Intervention Description
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 Measure Information:
Title
weight loss
Description
Body weight n in kilograms
Time Frame
before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Title
weight loss
Description
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.
Time Frame
before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Secondary Outcome Measure Information:
Title
patient's ability to attend the classes
Description
number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility
Time Frame
3 months after stem cell transplantation
Title
body mass index
Description
Measure of weight and height to evaluate the nutriotional status of a patient
Time Frame
before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Title
brachial muscle circumference
Description
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
Time Frame
before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Title
grip strength evaluation
Description
it is a measure of muscular strength
Time Frame
before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Title
short physical battery test
Description
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)
Time Frame
before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Title
Quality of Life Questionary C30 (QLQ-C30)
Description
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
Time Frame
before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Title
in house developped physical activities questionary
Description
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)
Time Frame
before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria :
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
Exclusion criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
SOLDATI Alizée
Phone
04 92 03 96 27
Email
soldati.a@chu-nice.fr
First Name & Middle Initial & Last Name or Official Title & Degree
LOSCHI Mickael, MD
Phone
04 92 03 90 25
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
SOLDATI Alizée
Organizational Affiliation
CHU NICE, hopital ARCHET 1, hématologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU NICE, hopital ARCHET 1, hématologie
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SOLDATI Alizée
12. IPD Sharing Statement
Learn more about this trial
Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy
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