Inspiratory Strength and Respiratory Complications After SCI Injury

NCT02891096 | Completed Results DMC

• 1 other identifier: 2015-14
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators conducting this study to investigate the relation between the respiratory muscle strength and respiratory complications. To understand more about respiratory complications the influence of different factors (such as in- and expiratory muscle strength, lung function parameters, physical activity, smoking, medications,…) on respiratory complications (such as pneumonia) will be investigated.

Conditions

Spinal Cord Injuries; Pneumonia

Keywords

respiratory complications; respiratory muscle strength; discriminator

Outcome Measures

Primary Outcomes (1)

• Pneumonia

  occurrence of pneumonia

  From date of spinal cord injury until discharge from primary rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)

Secondary Outcomes (3)

• Respiratory Function Measurements

  measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis

• Mortality Due to Pneumonia

  From date of spinal cord injury until discharge from inpatient rehabilitation (i.e. individual time window of observation from a few weeks to about 1 year)

• Respiratory Muscle Strength

  measured at inclusion at 28±12 days post injury (time window) or at 84±14 days post injury (time window) - first measurement of each patient used for analysis

Other Outcomes (1)

• Quality of Life in General

  in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge

Interventions

inspiratory muscle strength PROCEDURE

Measurements: * in- and expiratory muscle strength (5min) * lung function (FVC, FEV1, PEF, PCF) (10 min) Questionnaires: * ISCoS core data-set * ISCoS pulmonary function data sets * ISCoS quality of life questionnaire * questionnaire on individual respiratory muscle training, regular physical exercise and therapies * individual medication/vaccination and other medical complications will be assessed from patient's medical records All measurements will be performed at each of the 4 measurement time-points (up to 4 times during inpatient rehabilitation) and last about 40 min per patient and measurement time-point in total (time with patient).

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Individuals with spinal cord injury during primary inpatient rehabilitation in a specialized center.

You may qualify if:

• Initial rehabilitation after SCI
• men and women
• aqe over or equal 18 years
• AIS A, B, C or D lesion
• lesion level C1-T12

You may not qualify if:

• Neurologic diseases (e.g. MS, ALS)
• h mechanical ventilation dependency
• mental disorders

Sponsors & Collaborators

• Swiss Paraplegic Research, Nottwil: lead
• Balgrist University Hospital: collaborator
• Rehab Basel: collaborator
• Clinique Romande de Readaptation: collaborator
• Rehabilitation Clinic Tobelbad, Austria: collaborator
• Rehabilitation Center Haering, Austria: collaborator
• Austin Hospital, Melbourne Australia: collaborator
• Erasmus Medical Center: collaborator
• Heliomare Rehabilitation, Wijk aan Zee, The Netherlands: collaborator
• BG Unfallklinik Murnau: collaborator

Study Sites (1)

Swiss Paraplegic Centre Nottwil

Nottwil, Canton of Lucerne, 6207, Switzerland

Location

Related Publications (14)

• Lanig IS, Peterson WP. The respiratory system in spinal cord injury. Phys Med Rehabil Clin N Am. 2000 Feb;11(1):29-43, vii.

  PMID: 10680156 BACKGROUND

• Kang SW, Bach JR. Maximum insufflation capacity: vital capacity and cough flows in neuromuscular disease. Am J Phys Med Rehabil. 2000 May-Jun;79(3):222-7. doi: 10.1097/00002060-200005000-00002.

  PMID: 10821306 BACKGROUND

• Wang AY, Jaeger RJ, Yarkony GM, Turba RM. Cough in spinal cord injured patients: the relationship between motor level and peak expiratory flow. Spinal Cord. 1997 May;35(5):299-302. doi: 10.1038/sj.sc.3100370.

  PMID: 9160454 BACKGROUND

• Schilero GJ, Radulovic M, Wecht JM, Spungen AM, Bauman WA, Lesser M. A center's experience: pulmonary function in spinal cord injury. Lung. 2014 Jun;192(3):339-46. doi: 10.1007/s00408-014-9575-8. Epub 2014 Apr 11.

  PMID: 24723067 BACKGROUND

• Chamberlain JD, Meier S, Mader L, von Groote PM, Brinkhof MW. Mortality and longevity after a spinal cord injury: systematic review and meta-analysis. Neuroepidemiology. 2015;44(3):182-98. doi: 10.1159/000382079. Epub 2015 May 13.

  PMID: 25997873 BACKGROUND

• Tollefsen E, Fondenes O. Respiratory complications associated with spinal cord injury. Tidsskr Nor Laegeforen. 2012 May 15;132(9):1111-4. doi: 10.4045/tidsskr.10.0922. English, Norwegian.

  PMID: 22614314 BACKGROUND

• Liebscher T, Niedeggen A, Estel B, Seidl RO. Airway complications in traumatic lower cervical spinal cord injury: A retrospective study. J Spinal Cord Med. 2015 Sep;38(5):607-14. doi: 10.1179/2045772314Y.0000000254. Epub 2014 Aug 12.

  PMID: 25117865 BACKGROUND

• Aarabi B, Harrop JS, Tator CH, Alexander M, Dettori JR, Grossman RG, Fehlings MG, Mirvis SE, Shanmuganathan K, Zacherl KM, Burau KD, Frankowski RF, Toups E, Shaffrey CI, Guest JD, Harkema SJ, Habashi NM, Andrews P, Johnson MM, Rosner MK. Predictors of pulmonary complications in blunt traumatic spinal cord injury. J Neurosurg Spine. 2012 Sep;17(1 Suppl):38-45. doi: 10.3171/2012.4.AOSPINE1295.

  PMID: 22985369 BACKGROUND

• Croce MA, Fabian TC, Waddle-Smith L, Maxwell RA. Identification of early predictors for post-traumatic pneumonia. Am Surg. 2001 Feb;67(2):105-10.

  PMID: 11243529 BACKGROUND

• Postma K, Bussmann JB, Haisma JA, van der Woude LH, Bergen MP, Stam HJ. Predicting respiratory infection one year after inpatient rehabilitation with pulmonary function measured at discharge in persons with spinal cord injury. J Rehabil Med. 2009 Sep;41(9):729-33. doi: 10.2340/16501977-0410.

  PMID: 19774306 BACKGROUND

• Berlowitz DJ, Tamplin J. Respiratory muscle training for cervical spinal cord injury. Cochrane Database Syst Rev. 2013 Jul 23;2013(7):CD008507. doi: 10.1002/14651858.CD008507.pub2.

  PMID: 23881660 BACKGROUND

• Mueller G, Hopman MT, Perret C. Comparison of respiratory muscle training methods in individuals with motor and sensory complete tetraplegia: a randomized controlled trial. J Rehabil Med. 2013 Mar;45(3):248-53. doi: 10.2340/16501977-1097.

  PMID: 23389554 BACKGROUND

• Hajian-Tilaki K. Sample size estimation in diagnostic test studies of biomedical informatics. J Biomed Inform. 2014 Apr;48:193-204. doi: 10.1016/j.jbi.2014.02.013. Epub 2014 Feb 26.

  PMID: 24582925 BACKGROUND

• Raab AM, Brinkhof MWG, Berlowitz DJ, Postma K, Gobets D, Hirschfeld S, Hopman MTE, Huber B, Hund-Georgiadis M, Jordan X, Schubert M, Wildburger R, Mueller G. Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries. BMJ Open. 2020 Nov 5;10(11):e038204. doi: 10.1136/bmjopen-2020-038204.

  PMID: 33154049 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries; Pneumonia

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Dr Gabi Mueller
• Organization: Swiss Paraplegic Research

gabi.mueller@paraplegie.ch

+41419395563

Study Officials

• Gabi Mueller, PhD

  Swiss Paraplegic Centre Nottwil, Clinical Trial Unit

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2016
• First Posted: September 7, 2016
• Study Start: October 1, 2016
• Primary Completion: October 31, 2021
• Study Completion: October 31, 2021
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: From 1.1.2025 until 31.12.2029
• Access Criteria: official collaborating center ot this study or personnal request of data at the study center (PI) based on a clear hypothesis, protocol and analysis plan.

Locations

CH (1)