Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy

Обзор

Cell therapy (CT), including hematopoietic stem cell transplantation (HSCT) and advanced CAR T-cell therapies, is used for the treatment of oncohematological and other diseases. HSCT is associated with treatment-related toxicities, including fatigue, muscle weakness, and reduced functional capacity due to intensive conditioning chemotherapy, immunosuppressive treatments, corticosteroids, and complications such as infections or graft-versus-host disease. Emotional symptoms, including anxiety, depression, fear, and frustration, also affect patients' recovery and ability to regain functional independence. Evidence indicates that exercise interventions improve emotional well-being, fatigue, quality of life, physical function, cardiovascular fitness, and muscle mass in patients with hematological malignancies and HSCT recipients. Virtual reality (VR) has emerged as an innovative tool in rehabilitation, supporting patient motivation, exercise guidance, and monitoring. Immersive virtual reality (IVR), through head-mounted displays and multisensory environments, enhances the sense of presence and engagement. Studies suggest that IVR-based exercise programs are feasible, improving functional abilities, quality of life, satisfaction, and adherence. Since 2017, a Therapeutic Exercise program for patients admitted for HSCT has been implemented at Álvaro Cunqueiro Hospital (Vigo) through collaboration between the Physiotherapy Unit and the Hematology Department. Before admission, patients undergo a physical assessment, receive an individualized exercise plan, education, and a therapeutic exercise guide. Based on clinical experience, the team hypothesizes that integrating IVR into therapeutic exercise may improve motivation, adherence, and emotional well-being during hospitalization.

Подробное описание

Cell therapy patients, including hematopoietic stem cell transplantation (HSCT) and chimeric antigen receptor T-cell (CAR-T) therapy recipients, frequently experience significant physical and emotional impairments during hospitalization. Treatment-related factors such as intensive chemotherapy conditioning, immunosuppressive therapies, corticosteroid exposure, infections, and other complications may contribute to fatigue, reduced muscle strength, decreased functional capacity, anxiety, depression, and impaired quality of life.

Therapeutic exercise has demonstrated benefits in patients with hematological malignancies and HSCT recipients, improving physical function, fatigue, emotional symptoms, quality of life, and overall health status. However, maintaining motivation and adherence to exercise programs during prolonged hospital stays remains challenging.

Immersive virtual reality (IVR) has been increasingly investigated as a tool to enhance rehabilitation strategies. Through head-mounted displays and interactive virtual environments, IVR provides an immersive and engaging experience that may improve patient motivation, exercise participation, and emotional well-being. Previous studies have shown that IVR-based exercise interventions are feasible and may promote adherence and satisfaction in different clinical populations.

At Álvaro Cunqueiro Hospital (Vigo, Spain), a Therapeutic Exercise Program for patients undergoing hematopoietic stem cell transplantation has been implemented since 2017 through collaboration between the Physiotherapy Unit and the Hematology Department. This program includes pre-admission physical assessment, individualized exercise prescription, patient education, and monitoring during hospitalization.

This clinical trial aims to evaluate whether the addition of an immersive virtual reality intervention to a therapeutic exercise program improves adherence, feasibility, physical performance, emotional status, quality of life, and patient experience during hospitalization in patients receiving cellular therapy.

Вмешательства

• Устройство Intervention with IVR
  The RVI intervention program will consist of the following phases: * Phase 1: Exposure to introductory scenarios and use of the RVI software and hardware, adaptation to virtual environments, observation of passive scenarios aimed at emotional balance, and interactive scenarios involving general mobility and neuromuscular activation. Week 1. * Phase 2: Progression towards tasks that improve response times and attentional mechanisms. Starting in week 2. * Phase 3: More complex multicomponent phys
• Другое Control
  Intervention based on the standard treatment program of activities of routine clinical practice: Breathing exercises, resistance exercises with and without weights and aerobic exercises.

Первичные конечные точки

• Timed Up and Go (TUG) Test Time [Срок оценки: Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)]
• Five Times Sit-to-Stand (5xSTS) Test Time [Срок оценки: Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)]
• Handgrip Strength [Срок оценки: Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)]
• Two-Minute Step Test (2MST) Step Count [Срок оценки: Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)]
• Number of Scheduled Exercise Sessions [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Number of Clinically Feasible Exercise Sessions [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Number of Completed Exercise Sessions [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Percentage of Completed Clinically Feasible Exercise Sessions [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Exercise Session Duration [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Exercise Adherence [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]

Вторичные конечные точки (12)

• Sex [Срок оценки: Baseline (Day of admission)]
• Age [Срок оценки: Baseline (Day of admission)]
• Type of Hematopoietic Therapy [Срок оценки: Baseline (Day of admission)]
• Hematological Diagnosis [Срок оценки: Baseline (Day of admission)]
• Body Mass Index (BMI) [Срок оценки: Baseline (Day of admission)]
• Anxiety Score (HADS-A) [Срок оценки: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)]
• Depression Score (HADS-D) [Срок оценки: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)]
• Quality of Life (EORTC QLQ-C30) [Срок оценки: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)]
• Quality of Life (FACT-BMT) [Срок оценки: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)]
• Pain Intensity (Visual Analog Scale, VAS) [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Analgesic Treatment Level [Срок оценки: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)]
• Simulator Sickness Questionnaire (SSQ) Score [Срок оценки: During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)]

Критерии участия

Критерии включения

• Patients aged 18 years or older.
• Signed informed consent.
• Patients eligible for CT scan at the Alvaro Cunqueiro Hospital.
• Patients capable of performing therapeutic exercise independently, based on an objective initial functional assessment.
• The clinical investigator, in their professional judgment, determines that the patient can adhere to all study requirements.

Критерии исключения

• Patients under 18 years of age.
• Any medical condition or mental illness that could interfere with understanding HIP and CI.
• Patients participating in another clinical trial.
• Balance disorders that increase the risk of falls.
• Severe visual and/or auditory impairments that prevent participation in the session.
• History of vertigo, seizures, or epileptic fits.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Профилактика

Центры проведения

Испания · 1 центр

• Hospital Álvaro Cunqueiro (Vigo) — Vigo

Идентификаторы

NCT: NCT07679958 · RVI-ET

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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