Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFundacin Biomedica Galicia Sur

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intervention with IVR

    Device

    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

    Other intervention

    Intervention based on the standard treatment program of activities of routine clinical practice: Breathing exercises, resistance exercises with and without weights and aerobic exercises.

Treatment groups

144 Participants
are divided into 2 treatment groups
Group A: Intervention with IVRExperimental treatment 1 intervention
Group B: ControlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Timed Up and Go (TUG) Test Time

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.

Time frame
Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
2

Five Times Sit-to-Stand (5xSTS) Test Time

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.

Time frame
Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
3

Handgrip Strength

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.

Time frame
Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)
4

Two-Minute Step Test (2MST) Step Count

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.

Time frame
Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)

Secondary outcomes

1

Sex

Participant sex recorded at baseline and categorized as male or female.

Time frame
Baseline (Day of admission)
2

Age

Age of the participant at study enrollment, measured in years.

Time frame
Baseline (Day of admission)
3

Type of Hematopoietic Therapy

Type of hematological treatment received, categorized as autologous hematopoietic stem cell transplantation, allogeneic hematopoietic stem cell transplantation, or chimeric antigen receptor T-cell (CAR-T) therapy.

Time frame
Baseline (Day of admission)
4

Hematological Diagnosis

Primary hematological diagnosis recorded at baseline and classified according to diagnostic category.

Time frame
Baseline (Day of admission)

Other outcomes

Sponsors and contacts

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