Clinical trial NCT07024095: Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients
Official title: "Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture"
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Osteoporotic Vertebral Compression Fractures
Restrictive Pulmonary Disorders
Inspiratory Muscle Weakness
Postoperative Pulmonary Function
Keywords: Vertebroplasty
Functional Capacity
Respiratory Muscle Training
Rehabilitation
Physical Fitness
Lead sponsor: Istinye University
Sponsor class: OTHER
First posted: 2025-06-17
Enrollment: 24
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to one of two parallel groups using stratified randomization based on potential confounding variables such as age and sex:

* The intervention group will receive inspiratory muscle training (IMT) in addition to standard postoperative rehabilitation.
* The control group will receive only standard postoperative rehabilitation.

Randomization will be performed using a computer-generated stratified sequence, and group allocation will be concealed. The interventions will be conducted in parallel over a period of 8 weeks.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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 diaphragmatic mechanical efficiency and increase the work of breathing. Studies have shown a significant correlation between the degree of vertebral deformity and the degree of pulmonary dysfunction. A 2022 systematic review reported that increased Cobb angle in untreated idiopathic scoliosis is inversely related to forced vital capacity (FVC), VC, and TLC. Similarly, another study on adolescents who underwent thoracoplasty surgery for idiopathic scoliosis showed a significant postoperative decline in respiratory function.

Moreover, changes in respiratory function after PV are not solely due to pain reduction and mechanical improvements, but may also be influenced by physiological effects related to the surgery itself. Local tissue trauma during PV may affect the structural and functional integrity of paraspinal muscles in adjacent vertebral segments. This can result in inflammatory responses, spasms, or inhibition of paraspinal muscles, impairing spinal stability and indirectly limiting chest wall mobility. Additionally, protective breathing patterns due to postoperative pain may lead to dominant apical breathing instead of diaphragmatic breathing, causing inefficient respiratory muscle activity and reduced ventilation efficiency. Considering these physiological impacts, targeted inspiratory muscle training (IMT) in the postoperative period is viewed as a clinically important intervention to prevent or mitigate these adverse outcomes.

Although short-term improvements in pulmonary function following PV have been reported, there is no existing study that compares these improvements with healthy individuals. This creates uncertainty in determining the sufficiency and sustainability of post-PV functional gains relative to the pulmonary performance of the general population. Furthermore, most studies evaluating pulmonary function after PV provide limited long-term follow-up data, making it unclear whether the initial improvements are maintained or whether a decline occurs over time. IMT is thought to have the potential to support and enhance pulmonary function in the long term following PV. Studies have shown that IMT improves respiratory muscle strength, thoracic mobility, and dyspnea symptoms in patients undergoing thoracic surgery, and these effects are sustained in long-term follow-ups. Therefore, implementing IMT in patients after PV is clinically important to preserve the surgical gains, reduce pulmonary complications, and improve quality of life.

IMT is a well-established physiotherapeutic method proven effective following thoracic surgeries. It strengthens the respiratory muscles through resistance-based exercises, improving patients' respiratory capacity and functional recovery. Additionally, studies have shown that IMT can significantly improve balance, quality of life, and dyspnea. For example, a study investigating IMT in individuals with spinal cord injury found that six weeks of IMT significantly improved inspiratory muscle strength, quality of life, and pain compared to the placebo group. In another study by Kocjan et al., diaphragmatic thickness was evaluated via ultrasound following thoracic surgery, and a significant correlation between diaphragmatic thickness and balance levels was reported.

IMT has been shown to improve maximal inspiratory pressure and respiratory muscle endurance, thereby increasing exercise tolerance. Studies in patients with restrictive lung diseases also report that IMT enhances lung compliance and gas exchange efficiency, supporting ventilation-perfusion matching. In a study by Çalık et al., an 8-week IMT program in individuals with ankylosing spondylitis significantly improved respiratory muscle strength, functional exercise capacity, and Ankylosing Spondylitis Disease Activity Index scores. In another study evaluating paraplegic patients using wheelchairs following spinal cord injury, IMT led to significant improvements in aerobic capacity, respiratory muscle strength, and dyspnea compared to the control group.

Although the effects of respiratory muscle training on pulmonary function, muscle strength, quality of life, and balance have been studied in various restrictive pulmonary conditions, no study has evaluated its impact after PV. Therefore, this study aims to investigate the long-term effects of inspiratory muscle training on pulmonary function, inspiratory muscle strength, and quality of life in individuals who have undergone percutaneous vertebroplasty. It is anticipated that IMT may improve respiratory function by reducing dyspnea and enhance quality of life. Additionally, by reducing pulmonary complications, IMT may lead to decreased hospital admissions and lower healthcare costs. Given the limited literature evaluating the effects of IMT after PV, this study may provide a valuable contribution to the scientific literature and support the development of clinical rehabilitation protocols.

Eligibility criteria: 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.

Primary outcomes:
measure: Assessment of Forced Vital Capacity - FVC
timeFrame: Baseline, Week 4, and Week 8
Secondary outcomes:
measure: Assessment Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Baseline, week 4, week 8
measure: Assessment FEV1/FVC Ratio
timeFrame: Baseline, week 4, week 8
measure: Assessment Peak Expiratory Flow (PEF)
timeFrame: Baseline, week 4, week 8
measure: Assessment of Forced Expiratory Flow at 25-75% of Exhalation (FEF25-75)
timeFrame: Baseline, week 4, week 8
measure: Assessment of Respiratory Muscle Strength
timeFrame: Baseline, Week 4, and Week 8
measure: Assessment of Diaphragm Muscle Thickness
timeFrame: Baseline and Week 8
measure: Assessment of Diaphragm Muscle Elasticity
timeFrame: Baseline and Week 8
measure: Assessment of Functional Capacity
timeFrame: Baseline, Week 4, and Week 8
measure: Assessment of Quality of Life
timeFrame: Baseline, Week 4, and Week 8
measure: Assessment of Quality of Life
timeFrame: Baseline, Week 4, and Week 8
measure: Assessment of Kinesiophobia
timeFrame: Baseline, Week 4, and Week 8
Other outcomes:
Locations:
city: Kayseri
country: Turkey
facility: Nuh Naci Yazgan University, Faculty of Health Sciences - Cardiopulmonary Rehabilitation Unit
state: Kocasinan
Study officials:
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