APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU

ConditionsAdapted Physical Activity Hematological Malignancies Anxiety Relaxation

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-75

SponsorCentre Hospitalier Régional Metz-Thionville

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Subjects aged between 18 and 75 years old

Admitted in Intensive Care Unit

Informed consent

Disqualifiers

Contraindication for physical exercise

Inability to understand the French language (written and/or oral)

Ongoing involvement in another proprietary research protocol

Lack of affiliation to social security

Trial design

Design model

Parallel

Treatments tested in this trial

Classical APA group:
Behavioral
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state
APA with Exergaming device
Behavioral
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à classical cyclo-ergometer 3 - Cool down 15 to 20min / stretching / Objective: to bring the body back to a resting state
APA associated with biofeedback relaxation
Behavioral
Activity type: aerobic Frequency: 3sessions per week Duration of session: 30 to 60min Intensity: mild to moderate (4-6 on RPE Scale) Session description: 1 - Warm-up 5 to 10min / Activation of devices and systems: muscular, articular, cardiovascular / Objective: preparation of body and mind for physical activity. 2 - Training 10 to 30min physical activity with à Exergaming device 3 - Cool down: 20min / Biofeedback relaxation device / Objective: to bring the body back to a resting state

Treatment groups

90 Participants

are divided into 3 treatment groups

Group A: Classical APA groupExperimental treatment 1 intervention

Group B: APA with Exergaming deviceExperimental treatment 1 intervention

Group C: APA associated with biofeedback relaxationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

Change in State Anxiety by the State Trait Anxiety Inventory - YA Version

Self-reported questionnaire with 20 items assessed on a 4 points scale

Time frame

2 moments: at the beginning and directly at the end of program.

Secondary outcomes

Hospital Anxiety and Depression Scale

14 items Questionnaire to detect anxiety and depressive disorders

Time frame

Once at the inclusion

2min Walk Test (2MWT)

sub-maximal test to assess functional capacity

Time frame

: twice: at the beginning of the study and at the end: immediately after the APA program

Sit to Stand Test (SST)

Sub-maximal test to assess muscular strength

Time frame

twice: at the beginning of the study and at the end: immediately after the APA program

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.

Time frame

Twice: at the beginning of the study and at the end: just before hospital discharge.

Other outcomes

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

Time frame

twice: at the beginning of the study and at the end: immediately after the APA program.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centre Hospitalier Régional Metz-Thionville

Lead sponsor

University of Lorraine

Collaborator

Source ClinicalTrials.gov

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