Hematologic DiseasesRVI-ETNCT07679958
Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy
A study testing Intervention with IVR in people with Hematologic Diseases and Hematopoietic Stem Cell Transplantation, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hematologic Diseases, Hematopoietic Stem Cell Transplantation, Cellular Therapy
- What is being tested?
- Intervention with IVR
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 144 participants
- Where
- 1 siteSpain
- Study dates
- 15 Sep 2026to 1 Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site
Hospital Álvaro Cunqueiro (Vigo)
Vigo, Pontevedra, 36312
Carmen Albo López, MD, 986 217 832, carmen.albo.lopez@sergas.es
About this study
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.
Read the detailed description
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.
- Conditions
- Hematologic Diseases, Hematopoietic Stem Cell Transplantation, Cellular Therapy, Quality of Life, Oncologic Disorders
- Being tested
- Intervention with IVR, Control
- Keywords
- Therapeutic Exercise, Immersive virtual reality, Cellular therapy
- Medical subject headings
- Hematologic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with IVRDevice
Also called Oculus Quest 3, Meta Platforms
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.
ControlOther
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 group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Secondary outcomes (18)
Sex
Participant sex recorded at baseline and categorized as male or female.
Measured: Baseline (Day of admission)
Age
Age of the participant at study enrollment, measured in years.
Measured: Baseline (Day of admission)
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.
Measured: Baseline (Day of admission)
Hematological Diagnosis
Primary hematological diagnosis recorded at baseline and classified according to diagnostic category.
Measured: Baseline (Day of admission)
Body Mass Index (BMI)
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.
Measured: Baseline (Day of admission)
Anxiety Score (HADS-A)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: 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)
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.
Measured: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Analgesic Treatment Level
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).
Measured: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Simulator Sickness Questionnaire (SSQ) Score
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.
Measured: During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Game Experience Questionnaire (GEQ) Score
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.
Measured: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Satisfaction with the Immersive Virtual Reality (IVR) Intervention
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.
Measured: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Characteristics of Adverse Events
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).
Measured: During the intervention (from day 1 to hospital discharge, 28 days±2 weeks)
Perceived Exertion (Modified Borg Scale)
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.
Measured: After each exercise session (from day 1 to hospital discharge, 28 days±2 weeks)
Exercise Adherence During Follow-up
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%).
Measured: Follow-up (3 months ± 2 weeks)
Exercise Program Dropout Rate
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.
Measured: Follow-up (3 months ± 2 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start15 Sep 2026 (estimated)
- Primary completion1 Dec 2028 (estimated)
- Study completion1 Jun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hematologic DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 144 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacin Biomedica Galicia Sur
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Carmen Albo López, MD, Principal investigator, Galicia Sur Health Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07679958
- Sponsor's protocol ID
- RVI-ET
- Acronym
- RVI-ET
- Status last verified
- Sep 2026
- First submitted
- 18 Jun 2026
- Last updated
- 2 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy
- ClinicalTrials.gov ID
- NCT07679958
- Acronym / sponsor ID
- RVI-ET / RVI-ET
- Conditions
- Hematologic Diseases, Hematopoietic Stem Cell Transplantation, Cellular Therapy, Quality of Life, Oncologic Disorders
- Keywords
- Therapeutic Exercise, Immersive virtual reality, Cellular therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 144 participants (estimated)
- Lead sponsor
- Fundacin Biomedica Galicia SurUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 1 Dec 2028 (estimated)
- Study completion
- 1 Jun 2029 (estimated)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intervention with IVR | Experimental | Device: Intervention with IVRThe 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. |
| Control | Active comparator | Other: ControlUpon 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention with IVRAlso: Oculus Quest 3, Meta PlatformsThe 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. | Device | Intervention with IVR |
| ControlIntervention based on the standard treatment program of activities of routine clinical practice: Breathing exercises, resistance exercises with and without weights and aerobic exercises. | Other | Control |
Primary outcome
Timed Up and Go (TUG) Test Time
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
18 secondary outcomes
Sex
Time frame: Baseline (Day of admission)
Age
Time frame: Baseline (Day of admission)
Type of Hematopoietic Therapy
Time frame: Baseline (Day of admission)
Hematological Diagnosis
Time frame: Baseline (Day of admission)
Body Mass Index (BMI)
Time frame: Baseline (Day of admission)
Anxiety Score (HADS-A)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Analgesic Treatment Level
Time frame: During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks)
Simulator Sickness Questionnaire (SSQ) Score
Time frame: During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Game Experience Questionnaire (GEQ) Score
Time frame: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Satisfaction with the Immersive Virtual Reality (IVR) Intervention
Time frame: Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks)
Characteristics of Adverse Events
Time frame: During the intervention (from day 1 to hospital discharge, 28 days±2 weeks)
Perceived Exertion (Modified Borg Scale)
Time frame: After each exercise session (from day 1 to hospital discharge, 28 days±2 weeks)
Exercise Adherence During Follow-up
Time frame: Follow-up (3 months ± 2 weeks)
Exercise Program Dropout Rate
Time frame: Follow-up (3 months ± 2 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Carmen Albo López, MD principal investigator
Galicia Sur Health Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with IVR in people with Hematologic Diseases and Hematopoietic Stem Cell Transplantation, run by Fundacin Biomedica Galicia Sur at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carmen Albo López, MD (986 217 832, carmen.albo.lopez@sergas.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Timed Up and Go (TUG) Test Time (time frame: Baseline (Day of admission) and Follow-up (3 months ± 2 weeks)). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2026.