Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy

NCT07679958 | Not Yet Recruiting DMC

• 1 other identifier: RVI-ET
• Study Type: interventional
• Target: 144
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hematologic Diseases; Hematopoietic Stem Cell Transplantation; Cellular Therapy; Quality of Life; Oncologic Disorders

Keywords

Therapeutic Exercise; Immersive virtual reality; Cellular therapy

Outcome Measures

Primary Outcomes (10)

• 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.

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

• 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.

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

• 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.

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

• 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.

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

• Number of Scheduled Exercise Sessions

  The total number of scheduled exercise sessions completed by each participant during hospitalization. Higher values indicate greater adherence to the exercise intervention.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

• Number of Clinically Feasible Exercise Sessions

  The total number of exercise sessions considered feasible according to the participant's clinical condition during hospitalization, recorded as the number of sessions.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

• Number of Completed Exercise Sessions

  The total number of clinically feasible exercise sessions that were completed by the participant during hospitalization, recorded as the number of sessions.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

• Percentage of Completed Clinically Feasible Exercise Sessions

  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.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

• Exercise Session Duration

  Duration of each completed exercise session, measured in minutes. Higher values indicate longer exercise exposure per session.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

• Exercise Adherence

  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.

  During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)

Secondary Outcomes (18)

• Sex

  Baseline (Day of admission)

• Age

  Baseline (Day of admission)

• Type of Hematopoietic Therapy

  Baseline (Day of admission)

• Hematological Diagnosis

  Baseline (Day of admission)

• Body Mass Index (BMI)

  Baseline (Day of admission)

Study Arms (2)

Intervention with IVR

EXPERIMENTAL

The immersive virtual environment will be recreated using the Oculus Quest 3 system, distributed by Meta Platforms. This system is self-contained and requires only a virtual reality headset (HMD), two controllers, a Wi-Fi network, and some additional equipment. In each room, appropriate play areas will be defined based on the equipment, the software used, and the patient's health status at any given time. The virtual program will be structured progressively in terms of difficulty and complexity.

Device: Intervention with IVR

Control

ACTIVE COMPARATOR

Upon admission, the physiotherapist designs an exercise program tailored to the patient's condition, which includes: 1. Breathing exercises to facilitate proper respiratory function and prevent potential respiratory infections. These include diaphragmatic breathing, costal breathing, free flexion exercises of the upper extremities combined with deep breathing, and free adduction/abduction exercises of the upper extremities combined with deep breathing. 2. Resistance exercises with and without weights: to improve muscle metabolism, maintain the patient's physical capacity, and prevent sarcopenia. 3. Aerobic exercises: to maintain cardiovascular function.

Other: Control

Interventions

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.

Also known as: Oculus Quest 3, Meta Platforms

Intervention with IVR

Control OTHER

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

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Fundacin Biomedica Galicia Sur: lead

Study Sites (1)

Hospital Álvaro Cunqueiro (Vigo)

Vigo, Pontevedra, 36312, Spain

Location

MeSH Terms

Conditions

Hematologic Diseases

Interventions

Methods

Condition Hierarchy (Ancestors)

Hemic and Lymphatic Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

• Carmen Albo López, MD

  Galicia Sur Health Research Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carmen Albo López, MD

CONTACT

986 217 832; carmen.albo.lopez@sergas.es

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The evaluation of functional outcomes will be carried out by evaluators blinded to the assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized, controlled, longitudinal, prospective, open-label clinical trial with two parallel groups, evaluating a non-pharmacological intervention based on immersive virtual reality as support for therapeutic physical exercise in hospitalized patients undergoing cell therapy.

Study Record Dates

• First Submitted: June 18, 2026
• First Posted: July 1, 2026
• Study Start: July 24, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): June 1, 2029
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

ES (1)