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Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy (RVI-ET)

25. Juni 2026 aktualisiert von: Fundacin Biomedica Galicia Sur

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.

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

144

Phase

  • Unzutreffend

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienorte

  • Spanien
    • Pontevedra
      • Vigo, Pontevedra, Spanien, 36312

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Single

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Intervention with IVR
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.
Gerät: 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.
Andere Namen:
  • Oculus Quest 3
  • Meta Platforms
Aktiver Komparator: Control

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.
Sonstiges: 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.

Was misst die Studie?

Primäre Ergebnismessungen

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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Sex
Zeitfenster: Baseline (Day of admission)
Participant sex recorded at baseline and categorized as male or female.
Baseline (Day of admission)
Age
Zeitfenster: Baseline (Day of admission)
Age of the participant at study enrollment, measured in years.
Baseline (Day of admission)
Type of Hematopoietic Therapy
Zeitfenster: Baseline (Day of admission)
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.
Baseline (Day of admission)
Hematological Diagnosis
Zeitfenster: Baseline (Day of admission)
Primary hematological diagnosis recorded at baseline and classified according to diagnostic category.
Baseline (Day of admission)
Body Mass Index (BMI)
Zeitfenster: Baseline (Day of admission)
Body mass index calculated as weight in kilograms divided by height in meters squared (kg/m²). Higher values indicate greater body mass relative to height.
Baseline (Day of admission)
Anxiety Score (HADS-A)
Zeitfenster: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)
Anxiety symptoms assessed using the Hospital Anxiety and Depression Scale-Anxiety subscale (HADS-A). Scores range from 0 to 21, with higher scores indicating greater anxiety symptoms.
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)
Zeitfenster: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)
Depressive symptoms assessed using the Hospital Anxiety and Depression Scale-Depression subscale (HADS-D). Scores range from 0 to 21, with higher scores indicating greater depressive symptoms.
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)
Zeitfenster: Baseline (Day of admission), hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks) and Follow-up (3 months ± 2 weeks)
Health-related quality of life assessed using the EORTC QLQ-C30 questionnaire. Scores are transformed to a 0-100 scale according to EORTC scoring procedures. Higher scores on the global health status and functional scales indicate better quality of life, whereas higher scores on symptom scales indicate greater symptom burden.
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)
Zeitfenster: 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 related to bone marrow transplantation assessed using the Functional Assessment of Cancer Therapy-Bone Marrow Transplantation (FACT-BMT) questionnaire. Higher scores indicate better quality of life and well-being.
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)
Zeitfenster: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Pain intensity assessed using the Visual Analog Scale (VAS). Participants rate their perceived pain on a scale from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Analgesic Treatment Level
Zeitfenster: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Type of analgesic treatment prescribed according to the analgesic ladder classification: Level I (non-opioid analgesics), Level II (weak opioids), Level III (strong opioids), and Level IV (advanced analgesic interventions).
During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Simulator Sickness Questionnaire (SSQ) Score
Zeitfenster: During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Simulator sickness symptoms assessed using the Simulator Sickness Questionnaire (SSQ). The total score ranges from 0 to 48, with higher scores indicating greater severity of simulator sickness symptoms.
During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Game Experience Questionnaire (GEQ) Score
Zeitfenster: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
User experience during the game-based intervention assessed using the Game Experience Questionnaire (GEQ). The questionnaire evaluates four dimensions: Positive Experiences (mean score of items 1, 5, 7, 8, 12, and 16), Negative Experiences (mean score of items 2, 4, 6, 11, 14, and 15), Fatigue (mean score of items 10 and 13), and Return to Reality (mean score of items 3, 9, and 17). Each subscale is scored from 0 to 4, with higher scores indicating greater intensity of the corresponding experience.
Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Satisfaction with the Immersive Virtual Reality (IVR) Intervention
Zeitfenster: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Participant satisfaction with the immersive virtual reality (IVR) intervention assessed using an ad hoc satisfaction questionnaire. The questionnaire evaluates overall experience, perceived positive and negative aspects, willingness to repeat the intervention, recommendation of the intervention to others, and perceived usefulness of the intervention. Responses include qualitative feedback and categorical responses (yes/no). Higher satisfaction is indicated by positive responses regarding the experience, willingness to repeat, recommendation, and perceived usefulness.
Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Characteristics of Adverse Events
Zeitfenster: During the intervention (from day 1 to hospital discharge, 28 days±2 weeks)
Characteristics of adverse events occurring during the intervention, including type of event (exercise-related, immersive virtual reality [IVR]-related, or other), severity (mild, moderate, or severe), and causal relationship with the intervention (not related, possibly related, or probably related).
During the intervention (from day 1 to hospital discharge, 28 days±2 weeks)
Perceived Exertion (Modified Borg Scale)
Zeitfenster: After each exercise session (from day 1 to hospital discharge, 28 days±2 weeks)
Perceived exertion during exercise sessions assessed using the Modified Borg Rating of Perceived Exertion Scale. Scores range from 1 to 10, with higher scores indicating greater perceived effort during exercise.
After each exercise session (from day 1 to hospital discharge, 28 days±2 weeks)
Exercise Adherence During Follow-up
Zeitfenster: Follow-up (3 months ± 2 weeks)
Adherence to the prescribed exercise program during the 3-month follow-up period. Adherence is calculated based on frequency adherence (FA = completed exercise sessions / prescribed exercise sessions × 100), duration adherence (DA = completed average session duration / prescribed session duration × 100), and global adherence (GA = [FA + DA] / 2). Adherence is categorized as low (<50%), moderate (51-79%), or high (≥80%).
Follow-up (3 months ± 2 weeks)
Exercise Program Dropout Rate
Zeitfenster: Follow-up (3 months ± 2 weeks)
Proportion of participants who discontinued the exercise program during the 3-month follow-up period. Dropout rate is calculated as: (number of initiated but not completed sessions / total prescribed sessions) × 100.
Follow-up (3 months ± 2 weeks)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Fundacin Biomedica Galicia Sur

Ermittler

  • Hauptermittler: Carmen Albo López, MD, Galicia Sur Health Research Institute

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Geschätzt)

24. Juli 2026

Primärer Abschluss (Geschätzt)

1. Dezember 2028

Studienabschluss (Geschätzt)

1. Juni 2029

Studienanmeldedaten

Zuerst eingereicht

18. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

25. Juni 2026

Zuerst gepostet (Tatsächlich)

1. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

25. Juni 2026

Zuletzt verifiziert

1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • RVI-ET

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Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

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Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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