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

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.

Study Overview

• Status: Recruiting
• Conditions: Haematological Malignancy
• Intervention / Treatment: Other: 6 sessions of adapted physical activity after stem cell transplant

• Study Type: Interventional
• Enrollment (Estimated): 75
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: SOLDATI Alizée; Phone Number: 04 92 03 96 27; Email: soldati.a@chu-nice.fr
• Study Contact Backup: Name: LOSCHI Mickael, MD; Phone Number: 04 92 03 90 25

Study Locations

• France
  • Nice, France
    • Recruiting
    • CHU NICE, hopital ARCHET 1, hématologie
    • Contact: SOLDATI Alizée

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: adapted physical activity; 6 sessions of physical activity	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

What is the study measuring?

Primary 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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice
• Investigators: Principal Investigator: SOLDATI Alizée, CHU NICE, hopital ARCHET 1, hématologie

Study record dates

Study Major Dates

• Study Start (Actual): June 10, 2022
• Primary Completion (Estimated): December 10, 2026
• Study Completion (Estimated): April 10, 2028

Study Registration Dates

• First Submitted: May 9, 2022
• First Submitted That Met QC Criteria: May 13, 2022
• First Posted (Actual): May 18, 2022

Study Record Updates

• Last Update Posted (Actual): January 30, 2024
• Last Update Submitted That Met QC Criteria: January 29, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Hematologic Diseases; Neoplasms; Hematologic Neoplasms
• Other Study ID Numbers: 21-PP-12

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No