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

NCT ID: NCT04390087

Last Updated: 2024-05-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-11

Study Completion Date

2021-11-25

Brief Summary

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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.

Detailed Description

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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

Conditions

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Spinal Cord Injuries Exercise Training

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized controlled trial
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Exercise

Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity

Group Type EXPERIMENTAL

Exercise

Intervention Type OTHER

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

Control

The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Exercise

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Aage og Johanne Louis-Hansens Fond

OTHER

Sponsor Role collaborator

Aalborg University

OTHER

Sponsor Role lead

Responsible Party

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Rasmus Kopp Hansen

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Rasmus K Hansen, MSc

Role: PRINCIPAL_INVESTIGATOR

Aalborg University

Locations

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Aalborg University

Aalborg, , Denmark

Site Status

Countries

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Denmark

References

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Hansen RK, Laessoe U, Samani A, Mellergaard M, Rasmussen RW, Handberg A, Larsen RG. Impact of upper-body ergometer rowing exercise on aerobic fitness and cardiometabolic disease risk in individuals with spinal cord injury: A 6-month follow-up study. J Spinal Cord Med. 2024 Nov;47(6):996-1006. doi: 10.1080/10790268.2023.2233820. Epub 2023 Aug 3.

Reference Type DERIVED
PMID: 37534922 (View on PubMed)

Hansen RK, de Wit JLJ, Samani A, Laessoe U, Figlewski K, Larsen RG. Wheelchair-modified ergometer rowing exercise in individuals with spinal cord injury: a feasibility, acceptability, and preliminary efficacy study. Spinal Cord Ser Cases. 2022 Apr 30;8(1):48. doi: 10.1038/s41394-022-00518-6.

Reference Type DERIVED
PMID: 35487894 (View on PubMed)

Hansen RK, Samani A, Laessoe U, Handberg A, Larsen RG. Effect of wheelchair-modified rowing exercise on cardiometabolic risk factors in spinal cord injured wheelchair users: protocol for a randomised controlled trial. BMJ Open. 2020 Oct 16;10(10):e040727. doi: 10.1136/bmjopen-2020-040727.

Reference Type DERIVED
PMID: 33067301 (View on PubMed)

Other Identifiers

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N-20190053

Identifier Type: -

Identifier Source: org_study_id

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