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Trial record 17 of 10364 for:    strength

Inspiratory Strength and Respiratory Complications After SCI Injury (RESCOM)

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ClinicalTrials.gov Identifier: NCT02891096
Recruitment Status : Recruiting
First Posted : September 7, 2016
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Balgrist University Hospital
Rehab Basel
Clinique Romande de Readaptation
Rehabilitation Clinic Tobelbad, Austria
Rehabilitation Center Haering, Austria
Austin Hospital, Melbourne Australia
Erasmus Medical Center
Heliomare Rehabilitation, Wijk aan Zee, The Netherlands
BG Unfallklinik
Information provided by (Responsible Party):
Swiss Paraplegic Centre Nottwil

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.

Condition or disease Intervention/treatment
Spinal Cord Injuries Pneumonia Procedure: inspiratory muscle strength

  Show Detailed Description

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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
Study Start Date : October 2016
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : June 2020

Resource links provided by the National Library of Medicine



Intervention Details:
  • 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).



Primary Outcome Measures :
  1. 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.



Secondary Outcome Measures :
  1. 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.


  2. 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.


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Gabi Mueller, PhD +41 (0) 41 939 5563 gabi.mueller@paraplegie.ch
Contact: Anja M Raab, MSc +41 (0) 41 939 5966 anja.raab@paraplegie.ch

Locations
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Switzerland
Swiss Paraplegic Centre Nottwil Recruiting
Nottwil, Lucerne, Switzerland, 6207
Contact: Gabi Mueller, PhD    +41 (0) 41 939 5563    gabi.mueller@paraplegie.ch   
Contact: Anja M Raab, MSc    +41 (0) 41 939 5966    anja.raab@paraplegie.ch   
Principal Investigator: Gabi Mueller, PhD         
Sponsors and Collaborators
Swiss Paraplegic Centre Nottwil
Balgrist University Hospital
Rehab Basel
Clinique Romande de Readaptation
Rehabilitation Clinic Tobelbad, Austria
Rehabilitation Center Haering, Austria
Austin Hospital, Melbourne Australia
Erasmus Medical Center
Heliomare Rehabilitation, Wijk aan Zee, The Netherlands
BG Unfallklinik
Investigators
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Principal Investigator: Gabi Mueller, PhD Swiss Paraplegic Centre Nottwil, Clinical Trial Unit

Publications:

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Responsible Party: Swiss Paraplegic Centre Nottwil
ClinicalTrials.gov Identifier: NCT02891096     History of Changes
Other Study ID Numbers: 2015-14
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
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.
Keywords provided by Swiss Paraplegic Centre Nottwil:
respiratory complications
respiratory muscle strength
discriminator
Additional relevant MeSH terms:
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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