Impact of Adapted Physical Activity on Patient's Recovery Following Allogeneic Stem Cell Transplantation for Hematological Malignancy

Haematological Malignancy Clinical Trial

— APALLO  

Official title:

APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05379738
• Other study ID #: 21-PP-12
• Status: Recruiting
• Phase: N/A
• Start date: June 10, 2022
• Est. completion date: April 10, 2028

Study information

• Verified date: January 2024
• Source: Centre Hospitalier Universitaire de Nice
• Contact: SOLDATI Alizée
• Phone: 04 92 03 96 27
• Email: soldati.a[@]chu-nice.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. The study's goal is to observe if adaptated activity has an positive impact on weight loss and on life quality.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: April 10, 2028
• Est. primary completion date: December 10, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Haematological Malignancy
• Hematologic Neoplasms
• Neoplasms

Intervention

Other:
• 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

Locations

Country	Name	City	State
France	CHU NICE, hopital ARCHET 1, hématologie	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	weight loss	Body weight n in kilograms	before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation
Primary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	grip strength evaluation	it is a measure of muscular strength	before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation
Secondary	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
Secondary	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
Secondary	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