NCT05379738

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
75

participants targeted

Target at P50-P75 for not_applicable

Timeline
23mo left

Started Jun 2022

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress67%
Jun 2022Apr 2028

First Submitted

Initial submission to the registry

May 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
23 days until next milestone

Study Start

First participant enrolled

June 10, 2022

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 10, 2026

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 10, 2028

Last Updated

January 30, 2024

Status Verified

January 1, 2024

Enrollment Period

4.5 years

First QC Date

May 9, 2022

Last Update Submit

January 29, 2024

Conditions

Haematological Malignancy

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (7)

  • patient's ability to attend the classes

    3 months after stem cell transplantation

  • body mass index

    before stem cell transplantation, 1 month , 3 months, 1 year after stem cell transplantation

  • brachial muscle circumference

    before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation

  • grip strength evaluation

    before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation

  • short physical battery test

    before stem cell transplantation , 1 month , 3 months, 1 year after stem cell transplantation

  • +2 more secondary outcomes

Study Arms (1)

adapted physical activity

EXPERIMENTAL

6 sessions of physical activity

Other: 6 sessions of adapted physical activity after stem cell transplant

Interventions

6 sessions of adapted physical activity after stem cell transplantOTHER

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

adapted physical activity

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • Patients with a guardianship
  • Patients with a significant additional physic or mental disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU NICE, hopital ARCHET 1, hématologie

Nice, France

RECRUITING

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsHematologic DiseasesHemic and Lymphatic Diseases

Study Officials

  • SOLDATI Alizée

    CHU NICE, hopital ARCHET 1, hématologie

    PRINCIPAL INVESTIGATOR

Central Study Contacts

SOLDATI Alizée

CONTACT

04 92 03 96 27soldati.a@chu-nice.fr

LOSCHI Mickael, MD

CONTACT

04 92 03 90 25

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 9, 2022

First Posted

May 18, 2022

Study Start

June 10, 2022

Primary Completion (Estimated)

December 10, 2026

Study Completion (Estimated)

April 10, 2028

Last Updated

January 30, 2024

Record last verified: 2024-01

Locations

FR(1)