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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05475600
Other study ID # 2022-01-CHRMT
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 2, 2022
Est. completion date January 2025

Study information

Verified date July 2023
Source Centre Hospitalier Régional Metz-Thionville
Contact Johanne BOUSMIA
Phone 0033 6 83 43 16 28
Email johanne.bousmia@univ-lorraine.fr
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Adapted Physical Activity (APA) is accepted as an effective, recommended and beneficial supportive care for the health of people with cancer during the different phases of the disease. The objective of the project is to analyse the effect of APA programs (Classic, Exergaming and Relaxation) on the state anxiety of people with severe blood diseases admitted to Intensive Care Unit (ICU). Anxiety is a major affect in this context. The interest of the practice of APA for this public is to reduce the level of state anxiety and to limit the decline of functional capacities. The main objective of this work is to identify whether specific and/or complementary effects result from the use of biofeedback and/or Exergaming.


Description:

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Study Design


Intervention

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Locations

Country Name City State
France CHR Metz-Thionville/Hopital de Mercy Metz

Sponsors (2)

Lead Sponsor Collaborator
Centre Hospitalier Régional Metz-Thionville University of Lorraine

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Other Analysis of blood balance data Immune system activity by using the results of blood samples performed as part of the usual care protocol.
Data analysed include:
Polynuclear neutrophils rate
Leukocyte rate
Hemoglobin rate
Platelets rate
Haematocrit rate
twice: at the beginning of the study and at the end: immediately after the APA program.
Primary Change in State Anxiety by the State Trait Anxiety Inventory - YA Version Self-reported questionnaire with 20 items assessed on a 4 points scale 2 moments: at the beginning and directly at the end of program.
Secondary Hospital Anxiety and Depression Scale 14 items Questionnaire to detect anxiety and depressive disorders Once at the inclusion
Secondary 2min Walk Test (2MWT) sub-maximal test to assess functional capacity : twice: at the beginning of the study and at the end: immediately after the APA program
Secondary Sit to Stand Test (SST) Sub-maximal test to assess muscular strength twice: at the beginning of the study and at the end: immediately after the APA program
Secondary Multi-Fatigue Inventory_20 items (MFI-20) 20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue. Twice: at the beginning of the study and at the end: just before hospital discharge.
Secondary EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30 Questionnaire developed to assess the quality of life of cancer patients Twice: At the beginning of the study and one month after the intervention
Secondary Evaluation of the acute effect of an adapted physical activity session on the change in state Anxiety by the State Trait Anxiety Inventory - YA Version Self-reported questionnaire with 20 items assessed on a 4 points scale Twice at each moment: just before the session and directly after it to obtain the acute effect of the APA Session.
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