Rationale:
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'. 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.
Objective:
The primary aim of this study is to assess the effect of a personalized training
intervention on CRF during primary rehabilitation and at follow-up. Secondary aims of
this study are to determine the effect of this training 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.
Study population:
This study will include 32 iSCI patients classified with an American Spinal Injury
Association (ASIA) C or D in the subacute phase (< 6 months post injury), who are
referred for a primary, inpatient rehabilitation program at the Sint Maartenskliniek.
Intervention:
The intervention includes 2-3 personalized CRF-focused training sessions per week. The
control group receives usual care.
Main study parameters/endpoints:
The primary endpoint is the change in CRF (expressed as VO2peak) after the 6-weeks
intervention period and at follow-up.
Secondary outcomes are gait assessments, pulmonary function, neurological status, muscle
force, cardiometabolic risk factors, secondary complications, quality of life, functional
independence and exercise self-efficacy.
Measurements will be performed at:
T0 - Baseline
T1 - Following the 6-weeks intervention period during the primary rehabilitation program
at the Sint Maartenskliniek
T2* - At discharge from the primary rehabilitation program at the Sint Maartenskliniek
(only if the period following T1 is more than 2 weeks)
T3 - After 2 weeks in the outpatient rehabilitation program at the Sint Maartenskliniek
T4 - At discharge from the outpatient rehabilitation program at the Sint Maartenskliniek
T5 - 2 weeks following discharge from the outpatient rehabilitation program at the Sint
Maartenskliniek (2 weeks after T4)
T6 - 3 months following discharge from the outpatient rehabilitation program at the Sint
Maartenskliniek (3 months after T4, 2.5 months after T5)