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…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Pulmonary function, cough capacity and respiratory muscle force and endurance.
Secondary outcome
Respiratory complications and patient functioning
Background summary
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.
Study objective
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.
Intervention
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).
Study burden and risks
Subjects in the intervention group will perform IMT during 8 weeks, 30 minutes
a day, 5 times a week. All subjects will receive a standardized educational
module, consisting of 4 lessons of 30 minutes. Full measurements will take
place before, directly after, and 8 weeks after the training period. In
addition all subjects are asked weekly, between the first and third
measurement, to fill in a short written questionnaire concerning respiratory
complications, direct consequences and respiratory treatment. One year after
discharge from the inpatient setting, subjects are invited back to the
rehabilitation centre for a final and fourth measurement. The measurements cost
2 hours at a time. In the year post-discharge subjects are asked at three
different moments to fill in a written questionnaire. This will cost 15 minutes
each time. All subjects will possibly benefit from the structured attention and
objective measurements of respiratory function. The subjects in the
intervention group will possibly benefit from the intervention with improved
respiratory function and decreased respiratory complications. There are no
known risks for the intervention or measurements.
's Gravendijkwal 230
3015 CE Rotterdam
NL
's Gravendijkwal 230
3015 CE Rotterdam
NL
Listed location countries
Age
Inclusion criteria
1. recent Spinal Cord Injury
2. neurological classification: Thoracic 12 or above, ASIA A-D
3. decreased pulmonary function: FEV1<80% of predicted value
4. age 18-70 year
Exclusion criteria
1. progressive disease
2. psychiatric condition interfering with constructive participation
3. insufficient comprehension of the Dutch language
4. ventilator dependent
5. medically instable
Design
Recruitment
Medical products/devices used
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL28035.078.09 |