Clinical trial · Interventional
APA and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in ICU
Adapted Physical Activity and Relaxation by Biofeedback in Patients With Haematological Malignancy Admitted in Intensive Care unit_APAER_H Protocol
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adapted Physical Activity | — | UNRESOLVED | — |
| Anxiety | — | UNRESOLVED | — |
| Hematological Malignancies | Hematopoietic and Lymphoid Cell Neoplasm | ALIAS | 0.90 |
| Relaxation | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| APA associated with biofeedback relaxation | Behavioral | — | UNRESOLVED |
| APA with Exergaming device | Behavioral | — | UNRESOLVED |
| Classical APA group: | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Classical APA group
- description
- 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
- interventionNames
- Behavioral: Classical APA group:
- type
- EXPERIMENTAL
- label
- APA with Exergaming device
- description
- 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
- interventionNames
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDBousmia 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