Virtual Reality in Patients With Pulmonary Hypertension: A Randomized Controlled Trial
23 de abril de 2026 atualizado 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.
Visão geral do estudo
Status
Inscrevendo-se por convite
Condições
Intervenção / Tratamento
Descrição detalhada
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 estudo
Intervencional
Inscrição (Estimado)
32
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Fatih
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Istanbul, Fatih, Turquia (Türkiye), 34180
- Istanbul University-Cerrahpaşa/ Cardiology Institute
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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,
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: Control Group
Patients assigned to Group 2 will not included any intervention
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Muscle Strength
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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 resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Dyspnea assessment
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
31 de janeiro de 2026
Conclusão Primária (Estimado)
1 de janeiro de 2027
Conclusão do estudo (Estimado)
1 de janeiro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
19 de abril de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
23 de abril de 2026
Primeira postagem (Real)
30 de abril de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
30 de abril de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
23 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025/574
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
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Não
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