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.
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,
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.
Parallel
Inspiratory Muscle Training (IMT)
BehavioralParticipants 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.
control group
BehavioralParticipants 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).
Assessment of Forced Vital Capacity - FVC
Forced vital capacity (FVC) will be assessed using a Cosmed Pony FX spirometer (Rome, Italy). All measurements will be conducted in accordance with the standards of the European Respiratory Society (ERS) and American Thoracic Society (ATS), with participants seated during the procedure. Each participant will perform at least three acceptable maneuvers, and the highest value will be recorded for analysis. FVC results will be expressed both in liters (L) as absolute values and as percentage of predicted values based on reference equations (Miller et al., 2005). In addition, the lower limit of normal (LLN) for FVC will be calculated (Hankinson et al., 1999).
Assessment Forced Expiratory Volume in 1 Second (FEV1)
FEV1 will be measured using the Cosmed Pony FX spirometer following ERS/ATS standardized procedures. Participants will be instructed to perform at least three acceptable maneuvers, and the highest FEV1 value will be used for analysis. Results will be presented as liters (L) and as percent of predicted values based on standardized reference equations. The lower limit of normal (LLN) for FEV1 will also be determined (Hankinson et al., 1999).
Assessment FEV1/FVC Ratio
The FEV1/FVC ratio will be calculated using data obtained from spirometric testing with the Cosmed Pony FX spirometer. This parameter will be expressed as a percentage (%), and it will be used to assess the degree of airflow obstruction. Lower values of the FEV1/FVC ratio are indicative of obstructive respiratory patterns.
Assessment Peak Expiratory Flow (PEF)
Peak expiratory flow (PEF) will be measured to determine the maximum speed of expiration. Measurements will be conducted using the Cosmed Pony FX spirometer in accordance with ERS/ATS guidelines. PEF values will be expressed in liters per second (L/s). Higher values reflect better expiratory performance.
Assessment of Forced Expiratory Flow at 25-75% of Exhalation (FEF25-75)
FEF25-75 will be measured using the Cosmed Pony FX spirometer to assess mid-expiratory flow, which reflects small airway function. Participants will perform multiple spirometric maneuvers, and the highest acceptable value will be used in analysis. Results will be reported in liters per second (L/s).
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