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).

INTRODUCTION: Haematological malignancies and their treatments are known for their significant adverse effects on health-related quality of life (QoL). During high-dose cytotoxic therapy in haematological 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 populations, including oncological patients. Furthermore, adding new technology, such 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 Haematological Intensive Care Unit protocol is a randomised, controlled trial. Our study is designed to evaluate the effects of APA programmes during high-dose cytotoxic therapy 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, such as Exergaming and HRVB relaxation, on the aforementioned parameters. We expect a difference in effectiveness between the programmes concerning emotional regulation. METHODS AND ANALYSIS: 90 patients (18-75 years), with various forms of haematological malignancies admitted to HICU, with haematologist's approval for APA, who have given their written informed consent, will be randomly allocated in a 1:1:1 ratio to three 3-week APA groups: APA only (APA), APA by exergaming (EXER), APA+Biofeedback relaxation (BIO) (30:30:30). APA sessions will consist of moderate aerobic training on cyclo-ergometer (classical stationary bicycle for APA, BIO and connected ergometer in EXER), three 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). The primary outcome is to evaluate the effect of three short APA programmes on state anxiety (Hospital Anxiety and Depression Scale and State and Trait Anxiety Inventory-YA (STAI-YA)). The secondary outcomes will assess the effects on fatigue (Multidimensional Fatigue Inventory-20), physical fitness (2-minute walk test; five-times sit to stand test), QoL (European Organisation for Research and Treatment of Cancer - Quality of Life Questionnary ; EORTC-QLQ-C30) and immune system functioning (blood samples). All of these assessments are evaluated initially (T0) and directly after intervention (T2). ETHICS AND DISSEMINATION: Approval was obtained from the French South Mediterranean III ethical committee. Subjects are recruited after providing written consent after receiving the information provided by the investigator. According to French law and the French Data Protection Authority (Commission Nationale de l'Informatique et des Libertés ; CNIL), we are not authorised to publicly share individual participant data. The results of the Adapted Physical Activity, Exergaming and Relaxation by Biofeedback in Haematological Intensive Care Unit study will be disseminated through publication in peer-reviewed journals, presentations at scientific conferences and communication with stakeholders and participants. TRIAL REGISTRATION NUMBER: French Sud Mediteranian III ethical committee and registered on ClinicalTrials.gov: NCT05475600.