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NCT Number: NCT05379738

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU NICE, hopital ARCHET 1, hématologie

Nice, France

Location status: Recruiting

Location contact

SOLDATI Alizée

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

6 sessions of adapted physical activity after stem cell transplant

Other

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 outcomes

  1. weight loss

    Time frame: before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation

    Body weight n in kilograms

  2. weight loss

    Time frame: 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 outcomes

  1. patient's ability to attend the classes

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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

    Time frame: 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)

    Time frame: 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

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

LOSCHI Mickael, MD

CONTACT

04 92 03 90 25

SOLDATI Alizée

CONTACT

[email protected]

04 92 03 96 27

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Official study title

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

Acronym: APALLO

Important dates

Study start
2022
Primary completion
2026
Study completion
2028
First posted
May 18, 2022
Registry last updated
Jan 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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