NCT02891096: RESCOM

Inspiratory Strength and Respiratory Complications After SCI Injury

Completed Results posted Last updated 24 February 2025

What this trial tests

trial testing inspiratory muscle strength in Spinal Cord Injuries in 550 participants. Completed in 31 October 2021.

Timeline

1 October 2016

Primary endpoint
31 October 2021

31 October 2021

Quick facts

Lead sponsor	Swiss Paraplegic Research, Nottwil
Status	Completed
Study type	OBSERVATIONAL
Enrollment	550
Start date	1 October 2016
Primary completion	31 October 2021
Estimated completion	31 October 2021
Sites	1 location across Switzerland

Drugs / interventions tested

• inspiratory muscle strength

Conditions studied

• Spinal Cord Injuries — all drugs for Spinal Cord Injuries →
• Pneumonia — all drugs for Pneumonia →

Sponsor

Swiss Paraplegic Research, Nottwil — full company profile →

Who can join

18 and older, any sex, with Spinal Cord Injuries or Pneumonia. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Pneumonia Primary · 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)

occurrence of pneumonia

Group	Value	95% CI
Inpatient Rehab	70

Respiratory Function Measurements Secondary · 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

The various lung parameters thus include, vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and peak cough flow (PCF). The measurement of the lung function will be conducted in sitting position in the own wheelchair or for pedestrians on a chair and lasts at most 15 minutes. The peak cough flow (PCF) will be measured by having the person cough as forcefully as possible through a peak flow meter. The greatest value of each lung function parameter will be used for analysis.

FVC

Group	Value	95% CI
With Pneumonia	2.60	± 1.10
Without Pneumonia	3.18	± 1.09

FEV1

Group	Value	95% CI
With Pneumonia	2.20	± 0.90
Without Pneumonia	2.59	± 0.95

PEF

Group	Value	95% CI
With Pneumonia	292.4	± 130.1
Without Pneumonia	359.3	± 135.0

PCF

Group	Value	95% CI
With Pneumonia	319.9	± 150.0
Without Pneumonia	374.5	± 140.5

Mortality Due to Pneumonia Secondary · 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)

Mortality will be defined as pneumonia-related, if a prevailing event of pneumonia was clinically resolved as the initiating factor of the cascade of morbid events leading directly to death. Similarly, other causes of death will be recorded as part of all-cause mortality and as potentially competing risks of death.

Group	Value	95% CI
With Pneumonia	1
Without Pneumonia	1

Respiratory Muscle Strength Secondary · 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

maximal inspiratory pressure (MIP) and maximal expiratory pressure (MEP) The measurement will be conducted in sitting position in the own wheelchair or for pedestrians on a chair . The measurements will be conducted with a device for respiratory pressure measurement in which the patient has to inhale and exhale through a mouthpiece. Each measurement of the inspiration and expiration will be repeated 3 times per measurement time. The greatest value of each parameter will be used for analysis.

MIP

Group	Value	95% CI
With Pneumonia	60.4	± 24.8
Without Pneumonia	72.4	± 29.4

MEP

Group	Value	95% CI
With Pneumonia	50.5	± 24.8
Without Pneumonia	78.0	± 37.2

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Respiratory function and respiratory complications in spinal cord injury: protocol for a prospective, multicentre cohort study in high-income countries.
   Raab AM, Brinkhof MWG, Berlowitz DJ, Postma K, et al · · 2020 · cited 8× · PMID 33154049 · DOI 10.1136/bmjopen-2020-038204