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

NCT04390087 | Completed DMC

• 1 other identifier: N-20190053
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Spinal Cord Injuries; Exercise Training

Outcome Measures

Primary Outcomes (1)

• fasting insulin

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

  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)

Secondary Outcomes (24)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

Exercise

EXPERIMENTAL

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

Other: Exercise

Control

NO INTERVENTION

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

Interventions

Exercise OTHER

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

Exercise

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Aalborg University: lead
• Aage og Johanne Louis-Hansens Fond: collaborator

Study Sites (1)

Aalborg University

Aalborg, 9220, Denmark

Location

Related Publications (3)

• 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.

  PMID: 37534922 DERIVED

• 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.

  PMID: 35487894 DERIVED

• 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.

  PMID: 33067301 DERIVED

MeSH Terms

Conditions

Spinal Cord Injuries

Interventions

Exercise

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Rasmus K Hansen, MSc

  Aalborg University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized controlled trial

Study Record Dates

• First Submitted: May 6, 2020
• First Posted: May 15, 2020
• Study Start: January 11, 2021
• Primary Completion: November 25, 2021
• Study Completion: November 25, 2021
• Last Updated: May 31, 2024

Record last verified: 2024-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)