The primary aim of this study is to assess the effect of a personalized training intervention on CRF during primary rehabilitation. Secondary aims of this study are to determine the effect of this intervention on gait capacity, pulmonary function,…
ID
Source
Brief title
Condition
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary endpoint is the change in CRF (expressed as VO2peak) after the
6-weeks intervention period.
Secondary outcome
Secondary outcomes are gait capacity, pulmonary function, neurological status,
muscle force, cardiometabolic risk factors, secondary complications, QoL,
functional independence and exercise self-efficacy.
Background summary
Despite advances in medical care, spinal cord injury (SCI) patients have
significantly lower survival rates compared to the general population. The
*Koepelproject*, an unique world-leading multi-center research project,
discovered that SCI patients have a decreased pulmonary function, which is
linked to poor cardiorespiratory fitness (CRF). This leads to respiratory and
cardiovascular diseases, which are important predictors of death in SCI
patients. However, there are limitations of the *Koepelproject* which highlight
the need for the proposed project *FIT@HOME*. The Rehabilitation knowledge in
SCI patients is primarily focused on those with a complete lesion, while there
has been changes in the characteristics of the SCI population over the last few
decades. The diagnosis of an incomplete SCI (iSCI) is more common and requires
different insights and skills compared to patients with complete lesions.
Therefore, insight in the effect of personalized rehabilitation strategies
focussed on CRF during primary rehabilitation will provide important
information to support healthy ageing in iSCI patients.
Study objective
The primary aim of this study is to assess the effect of a personalized
training intervention on CRF during primary rehabilitation. Secondary aims of
this study are to determine the effect of this intervention on gait capacity,
pulmonary function, neurological status, muscle force, cardiometabolic risk
factors, quality of life (QoL), functional independence and exercise
self-efficacy.
Study design
The proposed study design is an explorative randomized controlled trial.
Intervention
The intervention includes 2-3 personalized CRF-focused training sessions per
week. The control group receives usual care.
Study burden and risks
iSCI patients who participate in this study may benefit from an improvement in
their CRF, resulting in a better health status. The maximal exercise test on
the arm cycle ergometer and the use of an electrocardiogram (ECG) can be seen
as a screening tool, determining safe exercise limits prior to the start of the
primary rehabilitation program. Furthermore, the risks of exercise testing are
low and patients will be continuously monitored by a physician during the
maximal exercise test. The measurements will be scheduled so that they do not
interfere with the rehabilitation program. Most of the study is conducted
within the usual rehabilitation program, therefore the patient burden
associated with participation in this study is minimal. The extra time
investment to participate in the study is estimated to be 4-5 hours in total
for both groups.
Hengstdal 3
Ubbergen 6574 NA
NL
Hengstdal 3
Ubbergen 6574 NA
NL
Listed location countries
Age
Inclusion criteria
* Diagnosis of incomplete spinal cord injury (SCI) based on a stable cause
(e.g. traumatic)
* Spinal cord injury classification C or D on the American Spinal Injury
Association (ASIA) impairment scale
* During this study in the subacute phase (< 6 months post injury)
* Hospitalized in the Sint Maartenskliniek for a primary, inpatient
rehabilitation program
* Aged 18 years or older
* Able to understand and perform study related procedures
* Capable to sit at least 3 times a day for 2 hours (prerequisites to start the
active rehabilitation program)
* The ability to use an arm ergometer
Exclusion criteria
* Unable to give informed consent (IC)
* Language barrier
* Participating in another interventional study targeting CRF
* Have contraindications to perform exercise during the rehabilitation program
Design
Recruitment
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 | NL81465.091.22 |