An interventional study of Exercise in Spinal Cord Injuries and Exercise Training, sponsored by Aalborg University. Completed at 1 site in Denmark. Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-05-31.
Sponsored by Aalborg University · Not applicable, Interventional, and Basic science
This randomized controlled trial will determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional cardiometabolic risk factors in SCI manual wheelchair users.
This randomized controlled trial aims to determine the effects of 12-weeks of wheelchair user-modified upper-body rowing on both traditional (insulin resistance, obesity, dyslipidemia (including low HDL-C and elevated TG and blood pressure) and novel (inflammatory status, autonomic nervous system function, vascular structure and function, and cardiorespiratory fitness level) cardiometabolic risk factors in SCI manual wheelchair users. As secondary objectives, this trial will investigate the effects of the exercise intervention on free-living physical activity, shoulder pain, and indices of quality of life.
Men and women, aged 18-65 years; chronic SCI (≥1 year since injury); individuals with sufficient sparing of arm function to participate in upper-body rowing; using a manual wheelchair as a primary tool for mobility will be included in the trial.
The exercise training will be conducted as wheelchair-modified upper-body ergometer rowing. The training will be performed for up to 30 min, 3 times per week with moderate-to-vigorous intensity, with at least one rest day between sessions.
Outcome measurements will be performed immediately before (baseline), after (post) 12 weeks of training, and 6 months after the termination of the intervention period (follow up). This approach allows for assessment of the short term effects of exercise training as well as any residual effects from the training intervention on cardiometabolic risk, shoulder pain, indices of quality of life, and free-living physical activity
1,948 studies on the registry are indexed under Spinal Cord Injuries; 505 are open to participants now.
This study's enrollment of 18 is below the median of 24 across 1,566 interventional studies indexed under Spinal Cord Injuries.
Browse Spinal Cord Injuries studies →Aalborg University is the lead sponsor of 178 studies on the registry; 37 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity
Other: Exercise
The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period
Upper-body rowing performed while participants are sitting in their own wheelchair.
fasting insulin
Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Arterial blood pressure
Resting systolic and diastolic BP will be measured with an automated blood pressure monitoring device
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Body mass
Body mass (kg)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Heart rate variability (HRV)
HRV will be derived from spectral analysis of the R-R interval obtained from the ECG.
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Vascular structure
Intima media thickness (mm)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Fasting blood glucose
Venous blood sampling
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Cardiorespiratory fitness level
Peak oxygen consumption
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Shoulder pain
the Wheelchair Users Shoulder Pain Index (WUSPI)). Consist of 15 items each consisting og a visual analog scales (pain from 0-10, with 10 representing maximum pain).
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Free-living physical activity
Wrist-worn accelerometer
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Health-related quality of life (HRQOL)
Short-form 36 (SF-36). 0-100, with 100 representing the best possible health.
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
body mass index
BMI (kg/m2)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Waist Circumference
Measured in cm
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Conduit artery function
Flow-mediated dilation (percent change from baseline)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Resistance vessel function
Reactive hyperemia (blood flow area under the curve)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Vascular function
Blood flow (ml/min)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Long-term blood glucose
HbA1c (percent)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
HDL cholesterol
Concentration (mmol/l)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
LDL cholesterol
concentration (mmol/l)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Triglyceride
concentration (mmol/l)
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
C-reactive protein
mg/l
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Alanin-aminotransferase
U/L
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Interleukin 6
Anti and pro-inflammatory cytokine
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Tumor necrosis factor-alpha
Pro-inflammatory cytokine
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Interleukin-10
Antoinflammatory cytokine
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Interleukin-1 receptor antagonist
Anti-inflammatory cytokine
Time frame: The between group difference in change in outcome will be examined from baseline to post intervention (12-weeks follow-up) (primary endpoint) and again from 12-weeks follow-up to 6-months follow-up (secondary endpoint)
Plan to share: No
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Aalborg University