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van CCT (UK)

van CCT (UK)

Inspiratory Muscle Training in persons with Spinal Cord Injury.

- candidate number6132
- NTR NumberNTR1921
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR22-jul-2009
- Secondary IDs28035.078.09 Erasmus MC, Rotterdam
- Public TitleInspiratory Muscle Training in persons with Spinal Cord Injury.
- Scientific TitleEffectiveness of Inspiratory Muscle Training (IMT) on respiratory function and patient functioning in persons with Spinal Cord Injury.
- hypothesisInspiratory 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) studiedSpinal Cord Injury, Respiratory complications, Respiratory muscle function
- Inclusion criteria1. 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 criteria1. Progressive disease;
2. Psychiatric condition;
3. Insufficient comprehension of the Dutch language;
4. Ventilator dependent or tracheotomy;
5. Medical instable.
- mec approval receivedyes
- multicenter trialyes
- randomisedyes
- masking/blindingSingle
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-sep-2009
- planned closingdate1-jun-2013
- Target number of participants40
- InterventionsInspiratory Muscle Training.
- Primary outcome1. Pulmonary function: FVC, FEV1, PEF;
2. Cough capacity: PCF;
3. Respiratory muscle function: PImax, PEmax;
4. Perceived respiratory function.
- Secondary outcome1. Respiratory symptoms;
2. Complications health related Quality of Life: SF-36.
- TimepointsMeasurements will be performed before training, directly after, 8 weeks after and one year after discharge from inpatient rehabilitation.
- Trial web siteN/A
- statusplanned
- Sponsor/Initiator Erasmus Medical Center, Department of Rehabilitation Medicine
- Funding
(Source(s) of Monetary or Material Support)
Stichting Rotterdams Kinderrevalidatie Fonds Adriaanstichting
- PublicationsN/A
- Brief summaryRationale:
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 functioning.
Study design:
Multi-centre single blind randomised control study.

Study population:
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)
- RECORD22-jul-2009 - 14-okt-2009

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