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NCT Number: NCT05475600

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

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

Location status: Recruiting

Location contact

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

About this study

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:

  • To reduce state anxiety level and psychological fatigue impact on GQoL and
  • To Maintain or improve functional capacities and reduce physical fatigue.

The main hypotheses are:

  • Each of the three programs leads to the objectives specified above.
  • APA associated with biofeedback relaxation reduce more state anxiety level than APA with Exergaming that is more effective than APA classic.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

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

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

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

Secondary outcomes

  1. Hospital Anxiety and Depression Scale

    Time frame: Once at the inclusion

    14 items Questionnaire to detect anxiety and depressive disorders

  2. 2min Walk Test (2MWT)

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

    sub-maximal test to assess functional capacity

  3. Sit to Stand Test (SST)

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

    Sub-maximal test to assess muscular strength

  4. Multi-Fatigue Inventory_20 items (MFI-20)

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

    20-item scale designed to evaluate five dimensions of fatigue: general fatigue, physical fatigue, reduced motivation, reduced activity, and mental fatigue.

  5. EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30

    Time frame: Twice: At the beginning of the study and one month after the intervention

    Questionnaire developed to assess the quality of life of cancer patients

  6. 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

    Time frame: Twice at each moment: just before the session and directly after it to obtain the acute effect of the APA Session.

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

Other outcomes

  1. Analysis of blood balance data

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Arpiné EL NAR, PhD

CONTACT

[email protected]

0033387557766

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Régional Metz-Thionville

Other

Collaborators

  • University of Lorraine

Registry information

Official study title

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

Acronym: APAER_H

Important dates

Study start
2022
Primary completion
2027
Study completion
2027
First posted
Jul 27, 2022
Registry last updated
Mar 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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