RecruitingNot ApplicableNCT07024095

Inspiratory Muscle Training After Vertebroplasty in Osteoporotic Fracture Patients

"Effects of Inspiratory Muscle Training on Pulmonary Function, Functional Capacity, and Quality of Life After Percutaneous Vertebroplasty in Individuals With Osteoporotic Vertebral Compression Fracture"


Sponsor

Istinye University

Enrollment

24 participants

Start Date

Jul 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 50 Years

Inclusion Criteria5

  • 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 Criteria4

  • 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.

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Interventions

BEHAVIORALInspiratory Muscle Training (IMT)

Participants in the intervention group will receive, in addition to the standard postoperative follow-up for 8 weeks (3 days per week), a home-based exercise program including diaphragmatic breathing exercises, stretching exercises targeting kyphotic posture, and strengthening exercises for the thoracic region. These exercises will be taught to the patients and their caregivers by a licensed physiotherapist before hospital discharge. In addition, inspiratory muscle training (IMT) will be performed every day for 8 weeks. To ensure progressive workload, maximal inspiratory pressure (MIP) will be reassessed weekly, and the IMT device will be adjusted accordingly.

BEHAVIORALcontrol group

Participants in the control group will receive, similar to the intervention group, a home-based exercise program for 8 weeks (3 days per week), including diaphragmatic breathing exercises, stretching exercises for kyphotic posture, and strengthening exercises for the thoracic region, in addition to standard postoperative follow-up. These exercises will be demonstrated to the patients and their caregivers by a licensed physiotherapist before hospital discharge. Unlike the intervention group, participants in this group will not receive inspiratory muscle training (IMT).


Locations(1)

Department of Neurosurgery, Kayseri State Hospital

Kayseri, Kocasinan, Turkey (Türkiye)

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