|- candidate number||6132|
|- NTR Number||NTR1921|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||22-jul-2009|
|- Secondary IDs||28035.078.09 Erasmus MC, Rotterdam|
|- Public Title||Inspiratory Muscle Training in persons with Spinal Cord Injury.|
|- Scientific Title||Effectiveness of Inspiratory Muscle Training (IMT) on respiratory function and patient functioning in persons with Spinal Cord Injury.|
|- hypothesis||Inspiratory Muscle Training during primary rehabilitation will improve respiratory function in Spinal Cord Injury.
Respiratory Muscle Training will decrease the risk for long-term respiratory symptoms and complications in persons with spinal cord injury.|
|- Healt Condition(s) or Problem(s) studied||Spinal Cord Injury, Respiratory complications, Respiratory muscle function|
|- Inclusion criteria||1. Subjects with SCI, admitted for primary SCI at an inpatient rehabilitationcentre;|
2. Motor level Thoracic 12 or higher;
3. ASIA A, B, C, or D;
4. Age 18 - 70;
5. Decreased pulmonary function; FEV1< 80% predicted value;
6. Written informed consent.
|- Exclusion criteria||1. Progressive disease;|
2. Psychiatric condition;
3. Insufficient comprehension of the Dutch language;
4. Ventilator dependent or tracheotomy;
5. Medical instable.
|- mec approval received||yes|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-sep-2009|
|- planned closingdate||1-jun-2013|
|- Target number of participants||40|
|- Interventions||Inspiratory Muscle Training.|
|- Primary outcome||1. Pulmonary function: FVC, FEV1, PEF;|
2. Cough capacity: PCF;
3. Respiratory muscle function: PImax, PEmax;
4. Perceived respiratory function.
|- Secondary outcome||1. Respiratory symptoms;|
2. Complications health related Quality of Life: SF-36.
|- Timepoints||Measurements will be performed before training, directly after, 8 weeks after and one year after discharge from inpatient rehabilitation.|
|- Trial web site||N/A|
|- CONTACT FOR PUBLIC QUERIES|| K. Postma|
|- CONTACT for SCIENTIFIC QUERIES|| K. Postma|
|- Sponsor/Initiator ||Erasmus Medical Center, Department of Rehabilitation Medicine|
(Source(s) of Monetary or Material Support)
|Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting|
|- Brief summary||Rationale:|
Patients with high-level Spinal Cord Injury (SCI) suffer
from disturbed function of respiratory muscles, resulting in decreased
vital capacity (VC) and decreased ability to cough. Because of this,
respiratory complications may occur, resulting in physical inactivity,
decreased fitness, morbidity, disability, a delay in the process of
recovery, and even mortality. An adequate and effective treatment of
respiratory function in SCI may help prevent this cascade of
deteriorating health consequences. Literature supports the potential of
inspiratory muscle training, but more evidence about the effectiveness
of this training, and about relevant relationships, determinants and
consequences related to pulmonary function, inactivity and respiratory
complications, is needed.
Evaluate the effectiveness of Inspiratory Muscle Training
(IMT) during primary rehabilitation on pulmonary function and
respiratory muscle strength in persons with SCI. Also, we will explore
the long-term effectiveness on respiratory complications and patient
Multi-centre single blind randomised control study.
Persons with SCI (n=40) and decreased pulmonary
function, in an early stage of inpatient rehabilitation.
All subjects, in the intervention and control group,
will receive the regular rehabilitation program and an added
standardized educational module concerning general aspects of the
respiratory function and risk of respiratory complications. The subjects
in the intervention group will receive an 8-week training program
focusing on inspiratory muscle strength. The training program exist of
threshold IMT exercises, 30 minutes a day, 5 times a week, once a week
supervised by a physical therapist (PT).
Main study parameters:
Pulmonary function, cough capacity and
respiratory muscle force and endurance.
|- Main changes (audit trail)|
|- RECORD||22-jul-2009 - 14-okt-2009|