Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
Ключови думи
Резюме
Описание
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
Дати
| Последна проверка: | 04/30/2020 |
| Първо изпратено: | 05/05/2020 |
| Очаквано записване подадено: | 05/12/2020 |
| Първо публикувано: | 05/14/2020 |
| Изпратена последна актуализация: | 05/12/2020 |
| Последна актуализация публикувана: | 05/14/2020 |
| Действителна начална дата на проучването: | 08/31/2020 |
| Приблизителна дата на първично завършване: | 02/28/2023 |
| Очаквана дата на завършване на проучването: | 11/30/2024 |
Състояние или заболяване
Интервенция / лечение
Other: Exercise
Фаза
Групи за ръце
| Arm | Интервенция / лечение |
|---|---|
| Experimental: Exercise Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity | Other: Exercise Upper-body rowing performed while participants are sitting in their own wheelchair. |
| No Intervention: Control The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period |
Критерии за допустимост
| Възрасти, отговарящи на условията за проучване | 18 Years Да се 18 Years |
| Полове, допустими за проучване | All |
| Приема здрави доброволци | Да |
| Критерии | 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. |
Резултат
Първични изходни мерки
1. fasting insulin [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)]
Вторични изходни мерки
1. Arterial blood pressure [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)]
2. Body mass [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)]
3. Heart rate variability (HRV) [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)]
4. Vascular structure [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)]
5. Fasting blood glucose [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)]
6. Cardiorespiratory fitness level [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)]
7. Shoulder pain [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)]
8. Free-living physical activity [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)]
9. Health-related quality of life (HRQOL) [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)]
10. body mass index [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)]
11. Waist Circumference [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)]
12. Conduit artery function [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)]
13. Resistance vessel function [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)]
14. Vascular function [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)]
15. Long-term blood glucose [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)]
16. HDL cholesterol [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)]
17. LDL cholesterol [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)]
18. Triglyceride [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)]
19. C-reactive protein [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)]
20. Alanin-aminotransferase [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)]
21. Interleukin 6 [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)]
22. Tumor necrosis factor-alpha [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)]
23. Interleukin-10 [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)]
24. Interleukin-1 receptor antagonist [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)]
