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Набира участници Не е приложимо NCT07024095

Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients

Не е приложима фаза (напр. обсервационно)
Заболявания: Osteoporotic Vertebral Compression Fractures Restrictive Pulmonary Disorders Inspiratory Muscle Weakness Postoperative Pulmonary Function

Спонсор: Istinye University

Налично на: БГ
Обобщение
This study investigates the long-term effects of inspiratory muscle training (IMT) on pulmonary function, functional capacity, and quality of life in individuals with osteoporotic vertebral compression fractures who have undergone percutaneous vertebroplasty. Participants aged 50 and older, diagnosed with osteoporosis and having undergone thoracic vertebroplasty within the past 3 months, will be randomly assigned to either an intervention group (IMT + standard rehabilitation) or a control group (standard rehabilitation only). The primary outcome measure is spirometry-based pulmonary function. Secondary outcome measures include inspiratory muscle strength, functional walking capacity (6-minute walk test), diaphragmatic structure and elasticity, and quality of life (SGRQ, NHP). This randomized controlled trial will be conducted at the Cardiopulmonary Rehabilitation Unit of Nuh Naci Yazgan University and aims to provide scientific evidence for integrating IMT into routine post-vertebroplasty rehabilitation protocols.
Описание
Vertebral compression fractures (VCFs) are among the most common complications of osteoporosis. In a Germany-based study, the annual incidence of VCFs in individuals aged 50 and above was reported as 307 per 100,000 people. The same study estimated the direct healthcare cost of VCFs to be approximately €6,490 within the first year after the fracture. The risk of VCF increases with age in both sexes, with a 40% rise in postmenopausal women. Although there is no specific epidemiological study on the incidence of VCFs in Turkey, a study conducted in 2025 reported an increased incidence of osteoporotic vertebral fractures due to limited access to healthcare and significantly reduced physical activity during the COVID-19 pandemic. Approximately one-third of osteoporotic VCFs are symptomatic and significantly reduce patients' quality of life. Whether symptomatic or asymptomatic, osteoporotic VCFs can lead to various health issues such as spinal deformities, nerve damage, functional limitations in thoracic and abdominal organs, reduced mobility, impaired pulmonary function, depression, and decreased quality of life. These fractures are also a major cause of acute and chronic back pain and are associated with increased risk of new fractures and mortality. Percutaneous vertebroplasty (PV) is a minimally invasive procedure commonly used in the treatment of spinal pain caused by osteoporotic fractures, vertebral hemangiomas, and metastatic tumors. First performed by Deramond et al. in 1987 for spinal hemangiomas, PV has since been widely adopted as an effective treatment for osteoporotic and neoplastic vertebral fractures. During the procedure, under fluoroscopic or CT guidance, polymethyl methacrylate (PMMA) cement is injected into the fractured or weakened vertebral body through a specialized needle. Early studies reported significant pain reduction following the procedure with rare complications. Even before being fully supported by high-quality randomized controlled trials, PV was incorporated into clinical practice and became part of standard treatment for osteoporotic vertebral fractures. Cadaveric studies have also shown that vertebral body rigidity and mechanical strength are restored following PMMA injection. Spinal pathologies such as vertebral fractures and deformities are known to cause restrictive pulmonary dysfunctions. Restrictive lung diseases encompass conditions characterized by reduced lung expansion capacity due to etiologies such as pulmonary fibrosis, neuromuscular diseases, and thoracic deformities. These conditions are associated with decreased total lung capacity (TLC), vital capacity (VC), and functional residual capacity (FRC), leading to impaired alveolar ventilation and increased respiratory muscle workload. Vertebral deformities, in particular, restrict chest wall mobility, preventing optimal function of respiratory muscles and reducing ventilatory capacity. The progressive nature of spinal deformities can reduce diaphragmati
Кой може да участва
Inclusion Criteria: * Being 50 years of age or older at the time of the study, * Having a diagnosis of osteoporosis confirmed by a specialist physician, * Having undergone percutaneous vertebroplasty surgery due to an osteoporotic vertebral compression fracture in the thoracic region within the past 3 months, * Being cooperative with the questionnaires and assessment methods to be used in the study, * Being able to read and voluntarily agree to participate in the study by signing the informed consent form. Exclusion Criteria: * Having a history of diagnosed unstable cardiac disease, * Having a diagnosed pulmonary or neurological disorder, * Having experienced an acute infection within the past 15 days, * Being unable to participate in exercise interventions due to mental or cognitive impairment.
Интервенции
Inspiratory Muscle Training (IMT)
BEHAVIORAL
control group
BEHAVIORAL
Места на провеждане 1
Турция (1)
Department of Neurosurgery, Kayseri State Hospital
Kayseri , Kocasinan
Технически детайли
Статус
Набира участници
Фаза
Не е приложимо
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
50 Years
Здрави доброволци
Не
Начална дата
01.07.2025
Крайна дата
30.04.2026
Регистрационен номер
NCT07024095
Източник
clinicaltrials.gov
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