Adapted Physical Activity, Exergaming and Relaxation by biofeedback in Hematological intensive care unit – Study protocol of a Randomised Controlled Trial (APAER-H trial)

Abstract Background: Hematological malignancies and their treatments are known for their significant adverse effects on health-related quality of life (QoL). During high-dose treatments in Hematological Intensive Care Units (HICU), Adapted Physical Activity (APA) is recognised for its role in maintaining physical fitness and limiting fatigue. Psychological and emotional states are also impaired, with anxiety levels significantly increasing in this specific context. Limited information is available about this topic. However, APA has been shown to reduce anxiety in various population, including oncological patients. Furthermore, adding new technology as exergaming or Heart Rate Variability Biofeedback (HRVB) relaxation tools could be an effective way to regulate emotions during treatments while providing the health-benefits of APA. APA, Exergaming and Relaxation by biofeedback in Hematological intensive care units protocol is a randomised, controlled trial. Our study is designed to evaluate the effects of APA programs during high-dose treatments in HICU on anxiety, fatigue level, functional capacities, immune system activity, and global QoL. Additionally, we aim to analyse the added-value of using specific devices as Exergaming and HRVB relaxation on the aforementioned parameters. We expect a difference in effectiveness between the programs concerning emotional regulation. Methods: Ninety patients (18–75 years), with various forms of hematological malignancies admitted to HICU, with haematologist’ approval for APA, will be randomly allocated in a 1:1:1 ratio to three 3-week APA groups: APA only (APA), APA by Exergaming (EXER), APA + HRVB relaxation (BIO). APA sessions will consist of moderate aerobic training on cyclo-ergometer (classical stationary bicycle for APA, BIO and connected ergometer in EXER), 3 times per week. The HRVB training will consist of controlled breathing exercises with biofeedback of heart rate variability at the end of each APA session (BIO). Discussion: The primary outcome is to evaluate the effect of 3 short APA programs on state anxiety (HADS; STAI-YA) and fatigue (MFI-20). The secondary outcomes will assess the effects on physical fitness (2MWT; FTSST), QoL (EORTC-QLQC30) and immune system functioning (blood samples). All of these assessments are evaluated initially (T1) and directly after (T2). Trial Registration: APAER-H protocol (version 1.1 of the 14/06/2022) was approved by the French Sud Mediteranian III ethical committee and registered on ClinicalTrials.gov: NCT05475600 (https://clinicaltrials.gov/).