Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy

Condition(s) studied

Investigational drug(s) / intervention(s)

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 physical exercise based on boxing techniques, movements of the upper limbs, trunk, head, and lower limbs, coordination exercises, and cyclical cardiovascular exercise.

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.

Study summary

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.

Eligibility

Primary outcome measure(s)

• Timed Up and Go (TUG) Test Time — Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
  The time (in seconds) required to stand up from a chair, walk 3 meters, turn around, walk back, and sit down. Lower values indicate better functional mobility.
• Five Times Sit-to-Stand (5xSTS) Test Time — Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
  The time (in seconds) required for a participant to rise from a standard chair and sit down five consecutive times as quickly as possible without using the upper limbs for assistance. Lower values indicate better lower-extremity muscle strength and functional performance.
• Handgrip Strength — Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
  andgrip strength is assessed using a handheld dynamometer. Participants perform a maximal voluntary isometric grip contraction according to standardized testing procedures. The highest value recorded is expressed in kilograms (kg). Higher values indicate greater muscle strength.
• Two-Minute Step Test (2MST) Step Count — Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
  Participants march in place for 2 minutes, raising each knee to a predetermined height midway between the patella and iliac crest. The outcome is the total number of times the right knee reaches the target height during the test, expressed as the number of steps. Higher values indicate better aerobic endurance and functional capacity.
• Number of Scheduled Exercise Sessions — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  The total number of scheduled exercise sessions completed by each participant during hospitalization. Higher values indicate greater adherence to the exercise intervention.
• Number of Clinically Feasible Exercise Sessions — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  The total number of exercise sessions considered feasible according to the participant's clinical condition during hospitalization, recorded as the number of sessions.
• Number of Completed Exercise Sessions — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  The total number of clinically feasible exercise sessions that were completed by the participant during hospitalization, recorded as the number of sessions.
• Percentage of Completed Clinically Feasible Exercise Sessions — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  The percentage of clinically feasible exercise sessions that were completed during hospitalization, calculated as: (completed feasible sessions / clinically feasible sessions) × 100. Higher values indicate greater compliance with the sessions considered feasible.
• Exercise Session Duration — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  Duration of each completed exercise session, measured in minutes. Higher values indicate longer exercise exposure per session.
• Exercise Adherence — During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
  Adherence to the exercise intervention, calculated as the percentage of completed exercise sessions relative to the number of scheduled exercise sessions: (completed sessions / scheduled sessions) × 100. Higher values indicate greater adherence to the intervention.

Trial sites (1)

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