NCT07024095

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2025

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2025

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
14 days until next milestone

Study Start

First participant enrolled

July 1, 2025

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2026

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2026

Completed
Last Updated

April 21, 2026

Status Verified

June 1, 2025

Enrollment Period

10 months

First QC Date

June 3, 2025

Last Update Submit

April 16, 2026

Conditions

Osteoporotic Vertebral Compression FracturesRestrictive Pulmonary DisordersInspiratory Muscle WeaknessPostoperative Pulmonary Function

Keywords

VertebroplastyFunctional CapacityRespiratory Muscle TrainingRehabilitationPhysical Fitness

Outcome Measures

Primary Outcomes (1)

  • 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).

    Baseline, Week 4, and Week 8

Secondary Outcomes (11)

  • Assessment Forced Expiratory Volume in 1 Second (FEV1)

    Baseline, week 4, week 8

  • Assessment FEV1/FVC Ratio

    Baseline, week 4, week 8

  • Assessment Peak Expiratory Flow (PEF)

    Baseline, week 4, week 8

  • Assessment of Forced Expiratory Flow at 25-75% of Exhalation (FEF25-75)

    Baseline, week 4, week 8

  • Assessment of Respiratory Muscle Strength

    Baseline, Week 4, and Week 8

  • +6 more secondary outcomes

Study Arms (2)

Ä°nspiratory traning group

EXPERIMENTAL

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.

Behavioral: Inspiratory Muscle Training (IMT)

Control Group

ACTIVE COMPARATOR

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).

Behavioral: control group

Interventions

Inspiratory Muscle Training (IMT)BEHAVIORAL

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.

Ä°nspiratory traning group
control groupBEHAVIORAL

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).

Control Group

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Neurosurgery, Kayseri State Hospital

Kayseri, Kocasinan, 38100, Turkey (TĂ¼rkiye)

RECRUITING

Related Publications (43)

  • Zhao H, He Y, Yang JS, Bao W, Chen J, Liu JJ, Li QD, Liu P, Qian B, Zhao YT, Hao DJ. Can paraspinal muscle degeneration be a reason for refractures after percutaneous kyphoplasty? A magnetic resonance imaging observation. J Orthop Surg Res. 2021 Aug 3;16(1):476. doi: 10.1186/s13018-021-02623-y.

    PMID: 34344407BACKGROUND

  • Wang B, Zhao CP, Song LX, Zhu L. Balloon kyphoplasty versus percutaneous vertebroplasty for osteoporotic vertebral compression fracture: a meta-analysis and systematic review. J Orthop Surg Res. 2018 Oct 22;13(1):264. doi: 10.1186/s13018-018-0952-5.

    PMID: 30348192BACKGROUND

  • Vasold KL, Parks AC, Phelan DML, Pontifex MB, Pivarnik JM. Reliability and Validity of Commercially Available Low-Cost Bioelectrical Impedance Analysis. Int J Sport Nutr Exerc Metab. 2019 Jul 1;29(4):406-410. doi: 10.1123/ijsnem.2018-0283.

    PMID: 30507268BACKGROUND

  • Tomas-Carus P, Biehl-Printes C, Del Pozo-Cruz J, Parraca JA, Folgado H, Perez-Sousa MA. Effects of respiratory muscle training on respiratory efficiency and health-related quality of life in sedentary women with fibromyalgia: a randomised controlled trial. Clin Exp Rheumatol. 2022 Jun;40(6):1119-1126. doi: 10.55563/clinexprheumatol/0v55nh. Epub 2022 Jun 22.

    PMID: 35748715BACKGROUND

  • Soumyashree S, Kaur J. Effect of inspiratory muscle training (IMT) on aerobic capacity, respiratory muscle strength and rate of perceived exertion in paraplegics. J Spinal Cord Med. 2020 Jan;43(1):53-59. doi: 10.1080/10790268.2018.1462618. Epub 2018 Apr 18.

    PMID: 29667507BACKGROUND

  • Robinson HC. Respiratory Conditions Update: Restrictive Lung Disease. FP Essent. 2016 Sep;448:29-34.

    PMID: 27576233BACKGROUND

  • Polatli M, Yorgancioglu A, Aydemir O, Yilmaz Demirci N, Kirkil G, Atis Nayci S, Kokturk N, Uysal A, Akdemir SE, Ozgur ES, Gunakan G. [Validity and reliability of Turkish version of St. George's respiratory questionnaire]. Tuberk Toraks. 2013;61(2):81-7. doi: 10.5578/tt.5404. Turkish.

    PMID: 23875584BACKGROUND

  • Pazzianotto-Forti EM, da Costa Munno CM, Merino DFB, Simoes da Rocha MR, de Mori TA, Junior IR. Effects of Inspiratory Exercise With Linear and Nonlinear Load on Respiratory Variables Post-Bariatric Surgery. Respir Care. 2019 Dec;64(12):1516-1522. doi: 10.4187/respcare.05841. Epub 2019 Aug 6.

    PMID: 31387894BACKGROUND

  • Palermo AE, Cahalin LP, Nash MS. A case for inspiratory muscle training in SCI: potential role as a preventative tool in infectious respiratory diseases like COVID-19. Spinal Cord Ser Cases. 2020 Sep 17;6(1):87. doi: 10.1038/s41394-020-00337-7.

    PMID: 32943611BACKGROUND

  • Noonan AM, Brown SHM. Paraspinal muscle pathophysiology associated with low back pain and spine degenerative disorders. JOR Spine. 2021 Sep 15;4(3):e1171. doi: 10.1002/jsp2.1171. eCollection 2021 Sep.

    PMID: 34611593BACKGROUND

  • Newall C, Stockley RA, Hill SL. Exercise training and inspiratory muscle training in patients with bronchiectasis. Thorax. 2005 Nov;60(11):943-8. doi: 10.1136/thx.2004.028928. Epub 2005 Jun 30.

    PMID: 15994254BACKGROUND

  • Mills DE, Johnson MA, Barnett YA, Smith WH, Sharpe GR. The effects of inspiratory muscle training in older adults. Med Sci Sports Exerc. 2015 Apr;47(4):691-7. doi: 10.1249/MSS.0000000000000474.

    PMID: 25116085BACKGROUND

  • Miller MR, Crapo R, Hankinson J, Brusasco V, Burgos F, Casaburi R, Coates A, Enright P, van der Grinten CP, Gustafsson P, Jensen R, Johnson DC, MacIntyre N, McKay R, Navajas D, Pedersen OF, Pellegrino R, Viegi G, Wanger J; ATS/ERS Task Force. General considerations for lung function testing. Eur Respir J. 2005 Jul;26(1):153-61. doi: 10.1183/09031936.05.00034505. No abstract available.

    PMID: 15994402BACKGROUND

  • Messaggi-Sartor M, Marco E, Martinez-Tellez E, Rodriguez-Fuster A, Palomares C, Chiarella S, Muniesa JM, Orozco-Levi M, Barreiro E, Guell MR. Combined aerobic exercise and high-intensity respiratory muscle training in patients surgically treated for non-small cell lung cancer: a pilot randomized clinical trial. Eur J Phys Rehabil Med. 2019 Feb;55(1):113-122. doi: 10.23736/S1973-9087.18.05156-0. Epub 2018 Jul 6.

    PMID: 29984565BACKGROUND

  • Liu JF, Kuo NY, Fang TP, Chen JO, Lu HI, Lin HL. A six-week inspiratory muscle training and aerobic exercise improves respiratory muscle strength and exercise capacity in lung cancer patients after video-assisted thoracoscopic surgery: A randomized controlled trial. Clin Rehabil. 2021 Jun;35(6):840-850. doi: 10.1177/0269215520980138. Epub 2020 Dec 14.

    PMID: 33307766BACKGROUND

  • Leake CB, Brinjikji W, Cloft HJ, Kallmes DF. Trends of inpatient spine augmentation: 2001-2008. AJNR Am J Neuroradiol. 2011 Sep;32(8):1464-8. doi: 10.3174/ajnr.A2503. Epub 2011 May 26.

    PMID: 21622578BACKGROUND

  • Le Corroller T, Arrigoni F. ESR Essentials: percutaneous bone consolidation-practice recommendations by the European Society of Musculoskeletal Radiology. Eur Radiol. 2025 Sep;35(9):5369-5380. doi: 10.1007/s00330-025-11478-4. Epub 2025 Mar 6.

    PMID: 40050453BACKGROUND

  • Lau E, Ong K, Kurtz S, Schmier J, Edidin A. Mortality following the diagnosis of a vertebral compression fracture in the Medicare population. J Bone Joint Surg Am. 2008 Jul;90(7):1479-86. doi: 10.2106/JBJS.G.00675.

    PMID: 18594096BACKGROUND

  • Lane JM, Nydick M. Osteoporosis: current modes of prevention and treatment. J Am Acad Orthop Surg. 1999 Jan;7(1):19-31. doi: 10.5435/00124635-199901000-00003.

    PMID: 9916187BACKGROUND

  • Laghi FA Jr, Saad M, Shaikh H. Ultrasound and non-ultrasound imaging techniques in the assessment of diaphragmatic dysfunction. BMC Pulm Med. 2021 Mar 15;21(1):85. doi: 10.1186/s12890-021-01441-6.

    PMID: 33722215BACKGROUND

  • Kucukdeveci AA, McKenna SP, Kutlay S, Gursel Y, Whalley D, Arasil T. The development and psychometric assessment of the Turkish version of the Nottingham Health Profile. Int J Rehabil Res. 2000 Mar;23(1):31-8. doi: 10.1097/00004356-200023010-00004.

    PMID: 10826123BACKGROUND

  • Kumar V, Vatkar AJ, Baburaj V, Najjar E, Bansal P. Pulmonary function after thoracoplasty for adolescent idiopathic scoliosis: a systematic review and meta-analysis. Eur Spine J. 2022 Nov;31(11):2972-2986. doi: 10.1007/s00586-022-07375-9. Epub 2022 Sep 7.

    PMID: 36069937BACKGROUND

  • Kumar K, Verma AK, Wilson J, LaFontaine A. Vertebroplasty in osteoporotic spine fractures: a quality of life assessment. Can J Neurol Sci. 2005 Nov;32(4):487-95. doi: 10.1017/s0317167100004492.

    PMID: 16408580BACKGROUND

  • Kocjan J, Gzik-Zroska B, Nowakowska K, Burkacki M, Suchon S, Michnik R, Czyzewski D, Adamek M. Impact of diaphragm function parameters on balance maintenance. PLoS One. 2018 Dec 28;13(12):e0208697. doi: 10.1371/journal.pone.0208697. eCollection 2018.

    PMID: 30592726BACKGROUND

  • Kempen DHR, Heemskerk JL, Kacmaz G, Altena MC, Reesink HJ, Vanhommerig JW, Willigenburg NW. Pulmonary function in children and adolescents with untreated idiopathic scoliosis: a systematic review with meta-regression analysis. Spine J. 2022 Jul;22(7):1178-1190. doi: 10.1016/j.spinee.2021.12.011. Epub 2021 Dec 25.

    PMID: 34963629BACKGROUND

  • Kanis JA. Assessment of fracture risk and its application to screening for postmenopausal osteoporosis: synopsis of a WHO report. WHO Study Group. Osteoporos Int. 1994 Nov;4(6):368-81. doi: 10.1007/BF01622200.

    PMID: 7696835BACKGROUND

  • Jung JH, Kim NS. Changes in training posture induce changes in the chest wall movement and respiratory muscle activation during respiratory muscle training. J Exerc Rehabil. 2018 Oct 31;14(5):771-777. doi: 10.12965/jer.1836366.183. eCollection 2018 Oct.

    PMID: 30443522BACKGROUND

  • Jones PW, Quirk FH, Baveystock CM, Littlejohns P. A self-complete measure of health status for chronic airflow limitation. The St. George's Respiratory Questionnaire. Am Rev Respir Dis. 1992 Jun;145(6):1321-7. doi: 10.1164/ajrccm/145.6.1321.

    PMID: 1595997BACKGROUND

  • Hernlund E, Svedbom A, Ivergard M, Compston J, Cooper C, Stenmark J, McCloskey EV, Jonsson B, Kanis JA. Osteoporosis in the European Union: medical management, epidemiology and economic burden. A report prepared in collaboration with the International Osteoporosis Foundation (IOF) and the European Federation of Pharmaceutical Industry Associations (EFPIA). Arch Osteoporos. 2013;8(1):136. doi: 10.1007/s11657-013-0136-1. Epub 2013 Oct 11.

    PMID: 24113837BACKGROUND

  • Hankinson JL, Odencrantz JR, Fedan KB. Spirometric reference values from a sample of the general U.S. population. Am J Respir Crit Care Med. 1999 Jan;159(1):179-87. doi: 10.1164/ajrccm.159.1.9712108.

    PMID: 9872837BACKGROUND

  • Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST.

    PMID: 31613151BACKGROUND

  • Galibert P, Deramond H, Rosat P, Le Gars D. [Preliminary note on the treatment of vertebral angioma by percutaneous acrylic vertebroplasty]. Neurochirurgie. 1987;33(2):166-8. French.

    PMID: 3600949BACKGROUND

  • Flegal KM. Body-mass index and all-cause mortality. Lancet. 2017 Jun 10;389(10086):2284-2285. doi: 10.1016/S0140-6736(17)31437-X. No abstract available.

    PMID: 28612744BACKGROUND

  • Enright PL. The six-minute walk test. Respir Care. 2003 Aug;48(8):783-5.

    PMID: 12890299BACKGROUND

  • Chen Y, Li J, Dong B, Zhu Z, Lyu G. Two-dimensional shear wave elastography: a new tool for evaluating respiratory muscle stiffness in chronic obstructive pulmonary disease patients. BMC Pulm Med. 2022 Nov 24;22(1):441. doi: 10.1186/s12890-022-02231-4.

    PMID: 36424581BACKGROUND

  • Bronheim R, Khan S, Carter E, Sandhaus RA, Raggio C. Scoliosis and Cardiopulmonary Outcomes in Osteogenesis Imperfecta Patients. Spine (Phila Pa 1976). 2019 Aug 1;44(15):1057-1063. doi: 10.1097/BRS.0000000000003012.

    PMID: 31335789BACKGROUND

  • Boswell-Ruys CL, Lewis CRH, Wijeysuriya NS, McBain RA, Lee BB, McKenzie DK, Gandevia SC, Butler JE. Impact of respiratory muscle training on respiratory muscle strength, respiratory function and quality of life in individuals with tetraplegia: a randomised clinical trial. Thorax. 2020 Mar;75(3):279-288. doi: 10.1136/thoraxjnl-2019-213917. Epub 2020 Jan 14.

    PMID: 31937553BACKGROUND

  • Borg GA. Psychophysical bases of perceived exertion. Med Sci Sports Exerc. 1982;14(5):377-81.

    PMID: 7154893BACKGROUND

  • Black LF, Hyatt RE. Maximal respiratory pressures: normal values and relationship to age and sex. Am Rev Respir Dis. 1969 May;99(5):696-702. doi: 10.1164/arrd.1969.99.5.696. No abstract available.

    PMID: 5772056BACKGROUND

  • Belkoff SM, Mathis JM, Jasper LE, Deramond H. The biomechanics of vertebroplasty. The effect of cement volume on mechanical behavior. Spine (Phila Pa 1976). 2001 Jul 15;26(14):1537-41. doi: 10.1097/00007632-200107150-00007.

    PMID: 11462082BACKGROUND

  • Basha MA, Azab AR, Elnaggar RK, Aboelnour NH, Kamel NM, Aloraini SM, Kamel FH. Inspiratory muscle training impact on respiratory muscle strength, pulmonary function, and quality of life in children with chest burn: A randomized controlled trial. Burns. 2024 Sep;50(7):1916-1924. doi: 10.1016/j.burns.2024.05.007. Epub 2024 May 10.

    PMID: 38782684BACKGROUND

  • Basbug G, Gurses HN, Zeren M, Elmadag NM. Effects of inspiratory muscle training on respiratory muscle strength, respiratory function and functional capacity in adolescents with idiopathic scoliosis : A randomized, controlled trial. Wien Klin Wochenschr. 2023 Jun;135(11-12):282-290. doi: 10.1007/s00508-023-02197-1. Epub 2023 Apr 18.

    PMID: 37071202BACKGROUND

  • Aktan R, Tertemiz KC, Yigit S, Ozalevli S, Ozgen Alpaydin A, Ucan ES. Effects of home-based telerehabilitation-assisted inspiratory muscle training in patients with idiopathic pulmonary fibrosis: A randomized controlled trial. Respirology. 2024 Dec;29(12):1077-1084. doi: 10.1111/resp.14810. Epub 2024 Aug 11.

    PMID: 39129185BACKGROUND

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Central Study Contacts

Oguzhan YILMAZ, MSc

CONTACT

+90 554 384 10 06oguzhanyilmaz68@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Masking Details
Participants will be blinded to their group assignment to reduce bias related to perception and response. Outcome assessors will also be blinded to ensure objective evaluation of study endpoints. Due to the nature of the intervention, care providers and investigators will not be blinded.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2025

First Posted

June 17, 2025

Study Start

July 1, 2025

Primary Completion

April 22, 2026

Study Completion

April 30, 2026

Last Updated

April 21, 2026

Record last verified: 2025-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)