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

Anxiety Clinical Trial

— APAER_H  

Official title:

Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05475600
• Other study ID #: 2022-01-CHRMT
• Status: Recruiting
• Phase: N/A
• 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
• 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:

Haematological malignancies have several unpleasant consequences on psychological and physical health. Indeed, an important fatigue and reduction of functional capacities appear. Reduction of functional capacities leads to the reduction of autonomy in Acts of Daily Living (ADL) and impact negatively the global Quality of Life (GQoL). Patients who undergo high dose treatment in protected area have higher risks of functional decline. In addition, hospital stay alone in sterile room favours increase of anxiety and depression.

Health care strategies are going to integrate and use more of support care as APA and relaxation. Regular APA practice leads to maintain and/or improve physical functioning and psychological well-being. Physical Activity ensures to maintain or develop muscular strength and cardio-respiratory capacities that patients loose if they stay inactive during hospital stay. APA practice participates too in regulation of emotional states. Indeed, it favours positive emotions as self-esteem, self-confidence, satisfaction and pleasure. In the order to limit or reduce anxiety level, relaxation provides an effective response. Maintain functional capacities and reduce negatives emotional states participate to reduce fatigue too. Also, APA associated with relaxation seems to be a good effective support care strategy.

The aim of this study is to implement a supervised APA program with entertaining devices as Exergaming and Biofeedback relaxation for patients undergo high dose treatment in protected area.

Exergaming consists on exercise and training through fun or recreative situations.

Biofeedback device is a relaxation tool that gives feedback on functioning of nervous system in real time. The objective is to leads patients to become aware of their body-information to finally, associate them to sensations and more effectively control them.

The objectives of this study are to:

1. To reduce state anxiety level and psychological fatigue impact on GQoL and

2. To Maintain or improve functional capacities and reduce physical fatigue.

The main hypotheses are:

1. Each of the three programs leads to the objectives specified above.

2. APA associated with biofeedback relaxation reduce more state anxiety level than APA with Exergaming that is more effective than APA classic.

3. APA with Exergaming and biofeedback practice gender more satisfaction and adhesion than APA classic

The program takes place 3 times per week. Each session lasts between 30 and 60 min. Intensity of effort is defined as light to moderate. Participants are assigned to one of the tree groups: 1-APA classic / 2-APA with Exergaming / 3-APA and Biofeedback relaxation. Aerobic activity is performed on a cyclo-ergometer (Groups 1 and 3) classic or exergaming (group 2). At the end of session, patients in relaxation group (Group 3) realise relaxation as recovery whereas other groups rest and stretch.

Functional capacities are assessed twice by submaximal tests: at the beginning and directly after APA program, just before hospital discharge. The first session affords to estimate subjects capacities and to create and individualised and adapted programme. The second affords to compare groups themselves and each other. Cardio-respiratory capacity is evaluated by the 2min Walk Test (2WT) and lower limbs muscular strength by the 5 Times Sit to Stand Test (FTSST). State anxiety level and fatigue are assessed by State and Trait Anxiety Inventory-YA (STAI-YA) and Multi-Fatigue Inventory_20items (MFI-20) respectively. At the inclusion, we complete the profile of individuals with the Hospital Anxiety and Depression Scale (HADS).

Adhesion and satisfaction are assessed by feedbacks of participants and by the comparison of the number of planned versus performed sessions.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Subjects aged between 18 and 75 years old

• Admitted in Intensive Care Unit

• Informed consent

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Adapted Physical Activity
• Anxiety
• Hematologic Neoplasms
• Hematological Malignancies
• Neoplasms
• Relaxation

Intervention

Behavioral:
• Classical APA group:
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
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
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

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.