- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07700550
VIRTUAL REALITY TRAINING AFTER THORACIC SURGERY (VRTS)
Effects of Exercise Training With Virtual Reality After Thoracic Surgery
Přehled studie
Postavení
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Denizli, Turecko (Türkiye), 20160
- Pamukkale University Hospital
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Popis
Inclusion Criteria:
Age between 25 and 70 years Stable symptoms and no other disease affecting pulmonary function (e.g., scoliosis or ankylosing spondylitis) Good cooperation and ability to walk independently Patients who underwent thoracic surgery FEV1 > 2 L for pneumonectomy, > 1 L for lobectomy, and > 0.6 L for segmentectomy Maximum oxygen consumption (VO₂max) > 15-20 mL/kg/min Cycle ergometer performance > 83 W No severe visual impairment Approved for participation in exercise training by the operating physician Hodkinson Mental Test score > 6 Willingness to participate and provision of informed consent -
Exclusion Criteria:
Contraindications to pulmonary rehabilitation or physiotherapy, including unstable cardiovascular disease, severe pulmonary hypertension, severe uncorrectable hypoxemia, exercise-induced desaturation, rib fractures, subcutaneous emphysema, advanced osteoporosis, or thrombocytopenia Orthopedic or neurological disorders that may impair independent ambulation, exertional dyspnea, or exertional vertigo Requirement for repeat thoracic surgery due to previous thoracic surgical history Inability to establish verbal and/or auditory communication and cooperation Inability to cooperate due to psychological and/or perceptual impairments Withdrawal Criteria Development of unexpected chest pain during the study Occurrence of syncope or nausea during testing procedures Participants may withdraw from the study at any time without providing a reason Study Completion / Termination Criterion Achievement of the planned sample size
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Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
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Aktivní komparátor: Conventional Pulmonary Rehabilitation Group
Participants received conventional pulmonary rehabilitation and cycle ergometer training after thoracic surgery.
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Participants received conventional pulmonary rehabilitation and cycle ergometer training after thoracic surgery.
Participants underwent thoracic surgery (lobectomy, segmentectomy, pneumonectomy, or wedge resection) according to the clinical indication before receiving the assigned rehabilitation intervention.
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Experimentální: Virtual Reality Exercise Training Group
Participants received conventional pulmonary rehabilitation, cycle ergometer training, and virtual reality-based exercise training after thoracic surgery.
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Participants received conventional pulmonary rehabilitation and cycle ergometer training after thoracic surgery.
Participants underwent thoracic surgery (lobectomy, segmentectomy, pneumonectomy, or wedge resection) according to the clinical indication before receiving the assigned rehabilitation intervention.
Participants received virtual reality-based exercise training in addition to conventional pulmonary rehabilitation and cycle ergometer training after thoracic surgery.
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
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FEV1
Časové okno: From baseline to 2 weeks after hospital discharge
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Forced expiratory volume in one second (FEV1) measured by spirometry.
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From baseline to 2 weeks after hospital discharge
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FVC
Časové okno: From baseline to 2 weeks after hospital discharge.
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Forced vital capacity (FVC) measured by spirometry.
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From baseline to 2 weeks after hospital discharge.
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FEF25-75
Časové okno: From baseline to 2 weeks after hospital discharge.
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Forced expiratory flow between 25% and 75% of forced vital capacity measured by spirometry.
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From baseline to 2 weeks after hospital discharge.
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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Pain Intensity
Časové okno: Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Pain intensity was assessed using the Visual Analog Scale (VAS).Pain intensity was assessed using the Visual Analog Scale (VAS), ranging from 0 to 10, where 0 indicates no pain and 10 indicates the worst imaginable pain.
Higher scores indicate greater pain intensity.
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Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Exercise Capacity
Časové okno: Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery)
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Exercise capacity was assessed using the 1-minute sit-to-stand test.Exercise capacity was assessed using the 1-minute sit-to-stand test (1-min STS).
The outcome was recorded as the number of completed sit-to-stand repetitions in one minute.
Higher values indicate better exercise capacity.
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Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery)
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Anxiety and Depression
Časové okno: Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Anxiety and depression were assessed using the Hospital Anxiety and Depression.
Anxiety was 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.
Depression was assessed using the Hospital Anxiety and Depression Scale - Depression subscale (HADS-D).
Scores range from 0 to 21, with higher scores indicating greater depression symptoms.
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Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Dyspnea
Časové okno: Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery)
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Dyspnea was assessed using the Modified Borg Dyspnea Scale.
Dyspnea was assessed using the Modified Borg Dyspnea Scale.
Scores range from 0 to 10, where 0 indicates no dyspnea and 10 indicates maximal dyspnea.
Higher scores indicate greater dyspnea severity.
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Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery)
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Oxygen Saturation
Časové okno: Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Peripheral oxygen saturation was measured before, immediately after, and 3 minutes after the 1-minute sit-to-stand test.Peripheral oxygen saturation (SpO₂) was measured using a pulse oximeter before, immediately after, and 3 minutes after the 1-minute sit-to-stand test.
Oxygen saturation was recorded as a percentage (%), with higher values indicating better oxygenation.
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Baseline, postoperative day 2, and hospital discharge (up to 7 days after surgery).
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Length of Hospital Stay
Časové okno: From the day of surgery until hospital discharge (typically within 7 days after surgery).
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Length of hospital stay was recorded as the total number of days from surgery until hospital discharge.
Shorter hospital stay indicates a better outcome.
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From the day of surgery until hospital discharge (typically within 7 days after surgery).
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Patient satisfaction
Časové okno: Hospital discharge (up to 7 days after surgery)
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Patient satisfaction was assessed using a short patient satisfaction questionnaire.Patient satisfaction was assessed using the Short Patient Satisfaction Questionnaire (SPSQ/HMKDF), which consists of 7 items rated on a 5-point Likert scale.
Total scores range from 7 to 35, with higher scores indicating greater patient satisfaction.
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Hospital discharge (up to 7 days after surgery)
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Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Orçin T ATALAY, PhD, Pamukkale University
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
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