Virtual Reality in Patients With Pulmonary Hypertension: A Randomized Controlled Trial
23 de abril de 2026 actualizado por: Gamze Öztürk, Istanbul University - Cerrahpasa
Effectiveness of Exercise Training Applied Through Virtual Reality in Patients With Pulmonary Hypertension
The goal of this research is to investigate the effectiveness of exercise administered via immersive virtual reality in patients with pulmonary hypertension, thereby contributing to the existing literature on this subject.
The main question is whether exercises delivered via immersive virtual reality are effective to improve physical performance, functional capacity, dyspnea, muscle strength, fatigue, quality of life, depression and anxiety.
Descripción general del estudio
Estado
Inscripción por invitación
Condiciones
Intervención / Tratamiento
Descripción detallada
The number of studies examining the effects of exercise training in pulmonary hypertension (PH) is limited in the literature.
Given the chronic nature of PH and the benefits of exercise in PH, the importance of exercise programs that include motivation as a factor becomes apparent.
Therefore, the aim of this research is to investigate the effectiveness of exercise programs implemented via virtual reality under the supervision of a physiotherapist in PH patients.
To investigators' knowledge, there are no studies in the literature examining the effectiveness of exercise training conducted via virtual reality in PH patients.
Therefore, another aim of this research is to identify virtual reality (VR) applications that can be used to improve clinical outcomes in PH patients and to contribute to the literature on the effectiveness of using innovative technologies in rehabilitation programs.
Tipo de estudio
Intervencionista
Inscripción (Estimado)
32
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Fatih
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Istanbul, Fatih, Turquía (Türkiye), 34180
- Istanbul University-Cerrahpaşa/ Cardiology Institute
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Descripción
Inclusion Criteria:
- Diagnosis of Idiopathic Pulmonary Arterial Hypertension,
- Stable pharmacological treatment for the past 3 months,
- Hemodynamic and clinical stability for at least the past three months,
- Age of 18-65,
- Voluntary participation in the study and signing the informed consent form,
- Being classified in the World Health Organization-Functional Classification I, II or III.
Exclusion Criteria:
- The presence of an orthopedic or neurological problem that will affect functional tests and muscle strength measurement,
- Acute decompensated heart failure,
- Unstable angina pectoris,
- Uncontrolled hypertension,
- The presence of problems that hinder communication,
- Dizziness, vertigo,
- Severe visual impairment,
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Virtual Reality Group
Patients assigned to Group 1 are involved in supervised exercise sessions 3 times a week during 8 weeks.
Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality
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Patients assigned to Group 2 are involved in supervised exercise sessions 3 times a week during 8 weeks.
Exercise sessions includes aerobic and strengthed exercises delivered via virtual reality
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Sin intervención: Control Group
Patients assigned to Group 2 will not included any intervention
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Muscle Strength
Periodo de tiempo: at the beginning of the study and at the end of 8 week,
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Lower and upper extremity strength: Measurement is performed by having the person being tested exert maximum effort against the device during the measurement, and the person conducting the test respond with maximum force in the opposite direction to prevent movement.
The tests are repeated three times, and the average of the values is recorded in Newtons (N).
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at the beginning of the study and at the end of 8 week,
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Hand Grip Strength
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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The tests will be repeated three times, and the average of the values will be recorded in kilograms of force (kgF).
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at the beginning of the study and at the end of 8 weeks
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Functional capacity of lower extremity
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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Six Minute Walking Test: Participants will be asked to walk as fast as possible at their own pace for 6 minutes on a 30-meter course.
The distance walked by the patient will be recorded in meters.
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at the beginning of the study and at the end of 8 weeks
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Functional capacity of upper extremity
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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Six Minute Pegboard and Ring Test: A wooden platform with bars will be used during the test.
Two bars will be placed at shoulder level and the other two 20 cm above shoulder level.
Ten rings, each weighing 14 grams, will be placed on the lower bars: ten on the right and ten on the left, for a total of 20 rings.
Patients will be asked to place as many rings as possible from the lower bars to the upper bars and then back to the lower bars using both hands for 6 minutes.
At the end of this time, the number of rings moved will be recorded as the the total score, and the resting time will be recorded in seconds.
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at the beginning of the study and at the end of 8 weeks
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Physical performance
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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Short Physical Performance Battery: The test consists of 3 tests: walking 4 meters, standing up from a chair, and standing balance test. Each test is scored between 0-4. The scores obtained by the participants, ranging from 1-4, indicate the progressive performance required to complete the test according to the specified times. Walking test: Participants will be asked to walk 4 meters in a pre-marked corridor, and the time will be recorded and scored. The use of walking aids will be permitted, and saturation monitoring will be performed. Standing up from a chair test: Participants will be asked to stand up once from a seated position with their arms crossed over their chest. Patients who can do this will be asked to stand up and sit down five times as quickly as possible, and the time will be recorded. Standing balance test: 3 positions will be used; feet side-by-side and together, tandem, and half-tandem. |
at the beginning of the study and at the end of 8 weeks
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Dyspnea assessment
Periodo de tiempo: at the beginning of the study and at the end of the 8 weeks
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Modified Medical Research Council Dyspnea Scale: This scale was developed to assess the level of dyspnea in patients.
The scale evaluates how much difficulty patients experience in daily life activities due to dyspnea.
Individuals indicate the degree of shortness of breath with a score between 0 and 4. Higher scores indicate a greater perception of dyspnea.
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at the beginning of the study and at the end of the 8 weeks
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Physical Activity Level Assessment
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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International Physical Activity Questionnaire - Short Form: This is a 7-question questionnaire developed to determine physical activity levels, covering the past week.
The questionnaire examines activities under the headings of vigorous physical activity, moderate physical activity, and walking.
All activities are recorded in terms of frequency (days/week) and duration (minutes/day).
A score in MET-min/week is calculated for all categories using a defined metabolic equivalent (MET) per activity, and the sum of these scores gives the total IPAQ-SF score.
Standard MET values are accepted as 3.3 for walking, 4.0 for moderate activity, and 8.0 for vigorous activity.
Sitting is assessed with a separate question and is not included in the total IPAQ-SF score.
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at the beginning of the study and at the end of 8 weeks
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Fatigue Assessment
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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Fatigue Severity Scale: The scale consists of 9 questions, each rated between 1 (strongly disagree) and 7 (strongly agree).
The total value is divided by 9 to obtain the final score.
An increased score indicates greater fatigue severity.
A score of <2.8 indicates no fatigue, while a score >6.1 indicates chronic fatigue.
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at the beginning of the study and at the end of 8 weeks
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Quality of life assessment
Periodo de tiempo: at the beginning of the study and at the end of 8 weeks
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EmPHasis 10: Developed for assessing quality of life in patients diagnosed with pulmonary hypertension, the EmPHasis-10 includes inquiries about significant consequences of the disease, such as shortness of breath, fatigue, and lack of energy, which can also affect social life.
The scale consists of 10 questions, each a Likert-type question scored between 0 and 5.
The total score of the scale ranges from 0 to 50 points.
A high score indicates a poor quality of life due to symptoms.
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at the beginning of the study and at the end of 8 weeks
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Depression and anxiety assessment
Periodo de tiempo: at the beginning of the study and at the end of the 8 weeks
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Hospital Anxiety and Depression Scale: The scale consists of 14 questions in total.
The Likert-type scale includes 7 questions to assess anxiety levels and 7 questions to assess depression levels.
Scores for both sub-assessments range from 0 to 21.
Higher scores indicate a worse level.
For both sub-assessments, scores of 0-7 indicate a normal level, 8-10 indicate borderline mood disorder, and ≥11 indicate a mood disorder.
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at the beginning of the study and at the end of the 8 weeks
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Virtual Reality Experience Assessment
Periodo de tiempo: at the beginning of the study and at the end of the 8 weeks
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Simulator Sickness Questionnaire: This is a scale that assesses the safety of experiences that alter the perception of reality, such as virtual reality, and the symptoms of motion sickness.
It consists of 16 items grouped into 3 subscales (oculomotor symptoms, disorientation, nausea).
Each item is rated on a four-point scale (0 = I feel nothing, 1 = somewhat, 2 = moderate, and 3 = very), and the total score is the sum of the scores of the three subscales.
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at the beginning of the study and at the end of the 8 weeks
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
31 de enero de 2026
Finalización primaria (Estimado)
1 de enero de 2027
Finalización del estudio (Estimado)
1 de enero de 2027
Fechas de registro del estudio
Enviado por primera vez
19 de abril de 2026
Primero enviado que cumplió con los criterios de control de calidad
23 de abril de 2026
Publicado por primera vez (Actual)
30 de abril de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
30 de abril de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
23 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 2025/574
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
SÍ
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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