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

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Recruiting
CT.gov ID
NCT05379738
Collaborator
(none)
75
1
1
35.7
2.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: 6 sessions of adapted physical activity after stem cell transplant
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
APALLO : Post Allogeneic Stem Cell Transplantation Adapted Physical Activity for Patient With Hematological Malignancies
Actual Study Start Date :
Jun 10, 2022
Anticipated Primary Completion Date :
Jun 1, 2025
Anticipated Study Completion Date :
Jun 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. weight loss [before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation]

    Body weight n in kilograms

  2. weight loss [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.

Secondary Outcome Measures

  1. patient's ability to attend the classes [3 months after stem cell transplantation]

    number of adaptated physical activity lessons attended by each patient after stem cell transplantation, calculation of feasibility

  2. body mass index [before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation]

    Measure of weight and height to evaluate the nutriotional status of a patient

  3. brachial muscle circumference [before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation]

    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

  4. grip strength evaluation [before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation]

    it is a measure of muscular strength

  5. short physical battery test [before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation]

    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)

  6. Quality of Life Questionary C30 (QLQ-C30) [before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation]

    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

  7. in house developped physical activities questionary [before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU NICE, hopital ARCHET 1, hématologie Nice France

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

  • Principal Investigator: SOLDATI Alizée, CHU NICE, hopital ARCHET 1, hématologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT05379738
Other Study ID Numbers:
  • 21-PP-12
First Posted:
May 18, 2022
Last Update Posted:
Jun 15, 2022
Last Verified:
Jun 1, 2022
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jun 15, 2022