Inspiratory Strength and Respiratory Complications After SCI Injury (RESCOM)
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ClinicalTrials.gov Identifier: NCT02891096 |
Recruitment Status :
Active, not recruiting
First Posted : September 7, 2016
Last Update Posted : February 26, 2021
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Condition or disease | Intervention/treatment |
---|---|
Spinal Cord Injuries Pneumonia | Procedure: inspiratory muscle strength |

Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | Inspiratory Muscle Strength and Respiratory Complications After Spinal Cord Injury: a Multicenter, Prospective Cohort Study |
Actual Study Start Date : | October 2016 |
Estimated Primary Completion Date : | December 2021 |
Estimated Study Completion Date : | December 2021 |

- Procedure: inspiratory muscle strength
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).
- Inspiratory muscle strength in relation to pneumonia [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]
Inspiratory muscle strength will be measured using a hand-held respiratory pressure meter (Micro RPM, Micro Medical, Hoechberg, Germany) by an independent study nurse of each participating study site. All measurements will be performed with the patients sitting upright in their own wheelchair.
Patients have to breathe through a mouthpiece while wearing a nose clip. Each measurement will be repeated three times. The greatest value of each parameter will be used for analysis.
- Lung function measurements [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]
The various lung parameters thus include maximum expiratory pressure (MEP), vital capacity (FVC), forced expiratory volume in 1 second (FEV1), peak expiratory flow (PEF) and peak cough flow (PCF).
The measurement of the respiratory muscle strength and 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 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 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.
- Mortality due to pneumonia [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]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.
- Quality of life in general [ Time Frame: in days post injury: T1:28±12; T2:84±14, T3:150±18; T4:15 days before discharge until discharge ]Quality of life (Qol) will be evaluated using the Quality of Life Basic Data Set of the International Spinal Cord Injury Datasets. This measurement instrument accepts (Qol) as a multi-facetted concept and includes three questions as to capture general quality of life (overall well-being), rating of physical health, and satisfaction with psychological health.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- Initial rehabilitation after SCI
- men and women
- aqe over or equal 18 years
- AIS A, B, C or D lesion
- lesion level C1-T12
Exclusion Criteria:
- Neurologic diseases (e.g. MS, ALS)
- 24h mechanical ventilation dependency
- mental disorders

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02891096
Switzerland | |
Swiss Paraplegic Centre Nottwil | |
Nottwil, Lucerne, Switzerland, 6207 |
Principal Investigator: | Gabi Mueller, PhD | Swiss Paraplegic Centre Nottwil, Clinical Trial Unit |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Swiss Paraplegic Centre Nottwil |
ClinicalTrials.gov Identifier: | NCT02891096 |
Other Study ID Numbers: |
2015-14 |
First Posted: | September 7, 2016 Key Record Dates |
Last Update Posted: | February 26, 2021 |
Last Verified: | February 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | In general, only the study investigators have access to the full study dataset in order to ensure that the overall results are not disclosed by an individual study site prior to the main publication. Site investigators are allowed to access the full dataset if a formal request describing their plans is approved by the study investigators. |
respiratory complications respiratory muscle strength discriminator |
Pneumonia Spinal Cord Injuries Wounds and Injuries Lung Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Spinal Cord Diseases Central Nervous System Diseases Nervous System Diseases Trauma, Nervous System |