Cooking Education and Adapted Physical Activity in Allografted Patients

NCT03829072 | Completed

• 1 other identifier: 18-PP-10
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

Majority of patients after allo stem cell transplantation have malnutrition and decrease of physical activities. This state impacts on quality of life and on outcome of some complications like infections, graft versus host disease and could decrease the overall survival. In this study, the investigators propose cooking education and adapted physical activity to improve that. Cooking education and adapted physical activity at home will be performed by two famous chefs for the first one and by a sportive coach for the second every twice week.

Conditions

Allograft

Keywords

Allo Stem Cell Transplantation; Cooking; Physical activity

Outcome Measures

Primary Outcomes (25)

• Body mass index

  Body mass index

  at pre transplant

• Body mass index

  Body mass index

  at Day 0

• Body mass index

  Body mass index

  at Day 30

• Body mass index

  Body mass index

  at Day 100

• Body mass index

  Body mass index

  at Day 300

• visual analogic scale of appetite

  It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values.

  at pre transplant

• visual analogic scale of appetite

  It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values

  at Day 0

• visual analogic scale of appetite

  It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values

  at Day 30

• visual analogic scale of appetite

  It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values

  at Day 100

• visual analogic scale of appetite

  It allows a visual assessment, by the patient himself, of his food intake, using an analog scale, or a choice of portions consumed.Visual analog scales (VAS) are reliable tools to evaluate hunger and satiety at point of food consumption. Score from 1 to 10. There are not better or worse values

  at Day 300

• sit up test

  sit up test

  at pre transplant

• sit up test

  sit up test

  at Day 0

• sit up test

  sit up test

  at Day 30

• sit up test

  sit up test

  at Day 100

• sit up test

  sit up test

  at Day 300

• bio electrical impedance analysis,

  it's measuring the resistance of biological tissues

  at pre transplant

• bio electrical impedance analysis,

  it's measuring the resistance of biological tissues

  at Day 0

• bio electrical impedance analysis,

  it's measuring the resistance of biological tissues

  at Day 30

• bio electrical impedance analysis,

  it's measuring the resistance of biological tissues

  at Day 100

• bio electrical impedance analysis,

  it's measuring the resistance of biological tissues

  at Day 300

• hand grip

  hand grip

  at pre transplant

• hand grip

  hand grip

  at Day 0

• hand grip

  hand grip

  at Day 30

• hand grip

  hand grip

  at Day 100

• hand grip

  hand grip

  at Day 300

Secondary Outcomes (20)

• Quality of life assessment,

  at pre transplant

• Quality of life assessment,

  at Day 0

• Quality of life assessment,

  at Day 30

• Quality of life assessment,

  at Day 100

• Quality of life assessment,

  at Day 300

Study Arms (1)

cooking Education and adapted physical activity

EXPERIMENTAL

Other: Cooking Education; Other: adapted physical activity

Interventions

Cooking Education OTHER

cooking Education and adapted physical activity on patients after allo stem cell transplantation

cooking Education and adapted physical activity

adapted physical activity OTHER

cooking Education and adapted physical activity on patients after allo stem cell transplantation

cooking Education and adapted physical activity

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient at least 18 years old
• Having been an allograft of CSH
• Patient having read and understood the information note related to the study, and signed the informed consent form.

You may not qualify if:

• Patient requiring nutritional support by enteral or parenteral route at J30
• Follow-up of the patient considered difficult by the investigator.
• Patient with a linguistic or psychic disability to understand the information.
• Vulnerable patient under legal protection

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de Nice - Hôpital de l'Archet

Nice, 06200, France

Location

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Thomas CLUZEAU

  Centre Hospitalier Universitaire de Nice

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: December 27, 2018
• First Posted: February 4, 2019
• Study Start: March 21, 2019
• Primary Completion: May 9, 2022
• Study Completion: February 12, 2023
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

FR (1)