- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07700550
VIRTUAL REALITY TRAINING AFTER THORACIC SURGERY (VRTS)
Effects of Exercise Training With Virtual Reality After Thoracic Surgery
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
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Denizli, Turkey (Türkiye), 20160
- Pamukkale University Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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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Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: 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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Experimental: 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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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
FEV1
Time Frame: 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
Time Frame: 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
Time Frame: 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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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Pain Intensity
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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
Time Frame: 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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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Orçin T ATALAY, PhD, Pamukkale University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- E-76351742-050.04-572695
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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