Skip to main content
OpenTrials
Completed

NCT Number: NCT04390087

Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Spinal Cord Injuries Central Nervous System Diseases Exercise Training Nervous System Diseases Spinal Cord Diseases Trauma, Nervous System Wounds and Injuries

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Aalborg University

Aalborg, 9220, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-65 years;
  • chronic SCI (≥1 year since injury)
  • individuals with sufficient sparing of arm function to participate in upper-body rowing (i.e. as a minimum excluding individuals with complete SCI at or above C5)
  • using a manual wheelchair as a primary tool for mobility.

Exclusion criteria

  • Individuals who regularly engage in >150 min/week of moderate-to-vigorous intensity physical activity
  • have received a cortisone injection in the shoulder within the last four months
  • have had shoulder injury within the previous year
  • known medical issues (urinary tract infections, cardiovascular contraindications for exercise testing, and pressure sores)
  • diagnosed diabetes or any endocrine, heart, kidney, liver disease or any other disease that may limit the ability to perform exercise.

Treatment and study plan

Exercise

Other

Upper-body rowing performed while participants are sitting in their own wheelchair.

Primary outcomes

  1. fasting insulin

    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)

    Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein

Secondary outcomes

  1. Arterial blood pressure

    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)

    Resting systolic and diastolic BP will be measured with an automated blood pressure monitoring device

  2. Body mass

    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 (kg)

  3. Heart rate variability (HRV)

    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)

    HRV will be derived from spectral analysis of the R-R interval obtained from the ECG.

  4. Vascular structure

    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)

    Intima media thickness (mm)

  5. Fasting blood glucose

    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)

    Venous blood sampling

  6. Cardiorespiratory fitness level

    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)

    Peak oxygen consumption

  7. Shoulder 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)

    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).

  8. Free-living physical activity

    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)

    Wrist-worn accelerometer

  9. Health-related quality of life (HRQOL)

    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)

    Short-form 36 (SF-36). 0-100, with 100 representing the best possible health.

  10. body mass index

    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)

    BMI (kg/m2)

  11. Waist Circumference

    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)

    Measured in cm

  12. Conduit artery function

    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)

    Flow-mediated dilation (percent change from baseline)

  13. Resistance vessel function

    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)

    Reactive hyperemia (blood flow area under the curve)

  14. Vascular function

    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)

    Blood flow (ml/min)

  15. Long-term blood glucose

    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)

    HbA1c (percent)

  16. HDL cholesterol

    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)

    Concentration (mmol/l)

  17. LDL cholesterol

    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)

    concentration (mmol/l)

  18. Triglyceride

    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)

    concentration (mmol/l)

  19. C-reactive protein

    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)

    mg/l

  20. Alanin-aminotransferase

    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)

    U/L

  21. Interleukin 6

    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)

    Anti and pro-inflammatory cytokine

  22. Tumor necrosis factor-alpha

    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)

    Pro-inflammatory cytokine

  23. Interleukin-10

    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)

    Antoinflammatory cytokine

  24. Interleukin-1 receptor antagonist

    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)

    Anti-inflammatory cytokine

Sponsors and collaborators

Lead sponsor

Aalborg University

Other

Collaborators

  • Aage og Johanne Louis-Hansens Fond

Registry information

Official study title

Effect of Wheelchair-modified Upper-body Rowing Exercise on Traditional and Novel Cardiometabolic Risk Factors in Spinal Cord Injured Wheelchair Users - Protocol for a Randomized Controlled Trial

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
May 15, 2020
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.