Inspiratory muscle training after thoracic vertebroplasty for osteoporotic spinal fractures
"Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture"
This study will test whether adding inspiratory muscle training to standard rehabilitation helps people aged 50 and older who had thoracic vertebroplasty for osteoporotic vertebral fractures breathe better, walk farther, and feel better overall.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 24 (estimated) |
| Ages | 50 Years and up |
| Sex | All |
| Sponsor | Istinye University Academic / other |
| Locations | 1 site (Kayseri, Kocasinan) |
| Trial ID | NCT07024095 on ClinicalTrials.gov |
What this trial studies
This randomized trial will enroll adults 50 years and older who underwent thoracic percutaneous vertebroplasty within the past three months and assign them to inspiratory muscle training plus standard rehabilitation or to standard rehabilitation alone. The IMT program is delivered alongside routine cardiopulmonary rehabilitation with scheduled follow-up visits for outcomes assessment. The primary outcome is spirometry-based pulmonary function, and secondary outcomes include inspiratory muscle strength, 6-minute walk distance, diaphragmatic structure and elasticity imaging, and quality of life (SGRQ, NHP). The trial is conducted at Kayseri State Hospital and aims to determine whether adding IMT produces durable respiratory and functional benefits after vertebroplasty.
Who should consider this trial
Good fit: Ideal candidates are people aged 50 or older with specialist-confirmed osteoporosis who had thoracic percutaneous vertebroplasty within the last three months and who can participate in rehabilitation and study assessments.
Not a fit: Patients with unstable cardiac disease, diagnosed chronic pulmonary or neurological disorders, recent acute infection, cognitive impairment preventing exercise participation, or those whose vertebroplasty occurred more than three months earlier are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If effective, adding IMT could improve breathing strength, walking capacity, and quality of life after vertebroplasty and be integrated into routine postprocedural rehabilitation.
How similar studies have performed: Inspiratory muscle training has shown benefits for inspiratory strength and some functional outcomes in COPD and postoperative rehab settings, but randomized evidence specifically after vertebroplasty is limited.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Kayseri, Kocasinan
- Department of Neurosurgery, Kayseri State Hospital — Kayseri, Kocasinan, Turkey (Türkiye) (Recruiting)
Study contacts
- Study coordinator: Oguzhan YILMAZ, MSc
- Email: oguzhanyilmaz68@gmail.com
- Phone: +90 554 384 10 06
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.