Immersive Virtual Reality Applied to Therapeutic Physical Exercise in Cellular Therapy
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- Timed Up and Go (TUG) Test Time
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
The evaluation of functional outcomes will be carried out by evaluators blinded to the assignment.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Intervention with IVR (Device)
Control
Upon admission, the physiotherapist designs an exercise program tailored to the patient's condition, which includes:
- 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.
- Resistance exercises with and without weights: to improve muscle metabolism, maintain the patient's physical capacity, and prevent sarcopenia.
- Aerobic exercises: to maintain cardiovascular function.
干预措施: Control (Other)
结局指标
主要结局
Timed Up and Go (TUG) Test Time
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
- 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))
- Anxiety Score (HADS-A)(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)(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)(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)(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)(During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks))
- Analgesic Treatment Level(During hospitalization (from day 1 to hospital discharge, 28 days ± 2 weeks))
- Simulator Sickness Questionnaire (SSQ) Score(During intervention, Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks))
- Exercise Adherence During Follow-up(Follow-up (3 months ± 2 weeks))
- Game Experience Questionnaire (GEQ) Score(Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks))
- Satisfaction with the Immersive Virtual Reality (IVR) Intervention(Intermediate assessment and hospital discharge (from day 1 to hospital discharge, 28 days±2 weeks))
- Characteristics of Adverse Events(During the intervention (from day 1 to hospital discharge, 28 days±2 weeks))
- Perceived Exertion (Modified Borg Scale)(After each exercise session (from day 1 to hospital discharge, 28 days±2 weeks))
- Exercise Program Dropout Rate(Follow-up (3 months ± 2 weeks))