Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
Primary Purpose
Spinal Cord Injuries, Exercise Training
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Exercise
Sponsored by
About this trial
This is an interventional basic science trial for Spinal Cord Injuries
Eligibility Criteria
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.
Sites / Locations
- Aalborg University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Exercise
Control
Arm Description
Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity
The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period
Outcomes
Primary Outcome Measures
fasting insulin
Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein
Secondary Outcome Measures
Arterial blood pressure
Resting systolic and diastolic BP will be measured with an automated blood pressure monitoring device
Body mass
Body mass (kg)
Heart rate variability (HRV)
HRV will be derived from spectral analysis of the R-R interval obtained from the ECG.
Vascular structure
Intima media thickness (mm)
Fasting blood glucose
Venous blood sampling
Cardiorespiratory fitness level
Peak oxygen consumption
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).
Free-living physical activity
Wrist-worn accelerometer
Health-related quality of life (HRQOL)
Short-form 36 (SF-36). 0-100, with 100 representing the best possible health.
body mass index
BMI (kg/m2)
Waist Circumference
Measured in cm
Conduit artery function
Flow-mediated dilation (percent change from baseline)
Resistance vessel function
Reactive hyperemia (blood flow area under the curve)
Vascular function
Blood flow (ml/min)
Long-term blood glucose
HbA1c (percent)
HDL cholesterol
Concentration (mmol/l)
LDL cholesterol
concentration (mmol/l)
Triglyceride
concentration (mmol/l)
C-reactive protein
mg/l
Alanin-aminotransferase
U/L
Interleukin 6
Anti and pro-inflammatory cytokine
Tumor necrosis factor-alpha
Pro-inflammatory cytokine
Interleukin-10
Antoinflammatory cytokine
Interleukin-1 receptor antagonist
Anti-inflammatory cytokine
Full Information
NCT ID
NCT04390087
First Posted
May 6, 2020
Last Updated
July 19, 2022
Sponsor
Aalborg University
Collaborators
Aage og Johanne Louis-Hansens Fond
1. Study Identification
Unique Protocol Identification Number
NCT04390087
Brief Title
Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
January 11, 2020 (Actual)
Primary Completion Date
November 25, 2021 (Actual)
Study Completion Date
November 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aalborg University
Collaborators
Aage og Johanne Louis-Hansens Fond
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
Detailed Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Spinal Cord Injuries, Exercise Training
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity
Arm Title
Control
Arm Type
No Intervention
Arm Description
The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period
Intervention Type
Other
Intervention Name(s)
Exercise
Intervention Description
Upper-body rowing performed while participants are sitting in their own wheelchair.
Primary Outcome Measure Information:
Title
fasting insulin
Description
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)
Secondary Outcome Measure Information:
Title
Arterial blood pressure
Description
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)
Title
Body mass
Description
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)
Title
Heart rate variability (HRV)
Description
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)
Title
Vascular structure
Description
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)
Title
Fasting blood glucose
Description
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)
Title
Cardiorespiratory fitness level
Description
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)
Title
Shoulder pain
Description
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)
Title
Free-living physical activity
Description
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)
Title
Health-related quality of life (HRQOL)
Description
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)
Title
body mass index
Description
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)
Title
Waist Circumference
Description
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)
Title
Conduit artery function
Description
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)
Title
Resistance vessel function
Description
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)
Title
Vascular function
Description
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)
Title
Long-term blood glucose
Description
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)
Title
HDL cholesterol
Description
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)
Title
LDL cholesterol
Description
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)
Title
Triglyceride
Description
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)
Title
C-reactive protein
Description
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)
Title
Alanin-aminotransferase
Description
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)
Title
Interleukin 6
Description
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)
Title
Tumor necrosis factor-alpha
Description
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)
Title
Interleukin-10
Description
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)
Title
Interleukin-1 receptor antagonist
Description
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rasmus K Hansen, MSc
Organizational Affiliation
Aalborg University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aalborg University
City
Aalborg
ZIP/Postal Code
9220
Country
Denmark
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
35487894
Citation
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. Erratum In: Spinal Cord Ser Cases. 2022 May 16;8(1):55.
Results Reference
derived
PubMed Identifier
33067301
Citation
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.
Results Reference
derived
Learn more about this trial
Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
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