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

NCT05475600 | Recruiting

• 1 other identifier: 2022-01-CHRMT
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Adapted Physical Activity; Hematological Malignancies; Anxiety; Relaxation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Hospital Anxiety and Depression Scale

  Once at the inclusion

• 2min Walk Test (2MWT)

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

• Sit to Stand Test (SST)

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

• Multi-Fatigue Inventory_20 items (MFI-20)

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

• EORTC quality of life questionnaire quality of life questionnaire (QLQ)-C30

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

Other Outcomes (1)

• Analysis of blood balance data

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

Study Arms (3)

Classical APA group

EXPERIMENTAL

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

Behavioral: Classical APA group:

APA with Exergaming device

EXPERIMENTAL

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

Behavioral: APA with Exergaming device

APA associated with biofeedback relaxation

EXPERIMENTAL

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

Behavioral: APA associated with biofeedback relaxation

Interventions

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

Classical APA group

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 with Exergaming device

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

APA associated with biofeedback relaxation

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged between 18 and 75 years old
• Admitted in Intensive Care Unit
• Informed consent

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Régional Metz-Thionville: lead
• University of Lorraine: collaborator

Study Sites (1)

CHR Metz-Thionville/Hopital de Mercy

Metz, 57085, France

RECRUITING

Related Publications (1)

• Bousmia J, Langlet C, Elnar AA, Goetz C, Bolmont B, Dorvaux V. Adapted physical activity, exergaming and relaxation by biofeedback in haematological intensive care unit in France: study protocol of a randomised controlled trial (APAER-H trial). BMJ Open. 2025 Dec 4;15(12):e099876. doi: 10.1136/bmjopen-2025-099876.

  PMID: 41344711 DERIVED

MeSH Terms

Conditions

Hematologic Neoplasms; Anxiety Disorders

Interventions

Glutamyl Aminopeptidase

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Aminopeptidases; Exopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloexopeptidases; Metalloproteases

Study Officials

• Véronique DORVAUX, MD

  CHR Metz Thionville Hopital de Mercy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arpiné EL NAR, PhD

CONTACT

0033387557766; projet-recherche-clinique@chr-metz-thionville.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2022
• First Posted: July 27, 2022
• Study Start: December 2, 2022
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: March 17, 2025

Record last verified: 2025-03

Locations

FR (1)