Spinal Cord InjuriesNCT04390087
Effect of Upper-body Rowing on Cardiometabolic Risk in Spinal Cord Injured Wheelchair Users
A study testing Exercise in people with Spinal Cord Injuries and Exercise Training, run by Aalborg University at 1 site in Denmark.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Spinal Cord Injuries, Exercise Training
- What is being tested?
- Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 11 Jan 2021to 25 Nov 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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
- Conditions
- Spinal Cord Injuries, Exercise Training
- Being tested
- Exercise
- Medical subject headings
- Spinal Cord Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ExerciseOther
Upper-body rowing performed while participants are sitting in their own wheelchair.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | Upper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity Receives: Other: Exercise |
| Control | No intervention | The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period |
What is being measured
The primary outcome is the main question the study is designed to answer.
fasting insulin
Serum fasting insulin concentration will be measured from approximately 20 mL blood drawn from a peripheral vein
Measured: 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
Resting systolic and diastolic BP will be measured with an automated blood pressure monitoring device
Measured: 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
Body mass (kg)
Measured: 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)
HRV will be derived from spectral analysis of the R-R interval obtained from the ECG.
Measured: 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
Intima media thickness (mm)
Measured: 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
Venous blood sampling
Measured: 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)
Cardiorespiratory fitness level
Peak oxygen consumption
Measured: 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)
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).
Measured: 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)
Free-living physical activity
Wrist-worn accelerometer
Measured: 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)
Health-related quality of life (HRQOL)
Short-form 36 (SF-36). 0-100, with 100 representing the best possible health.
Measured: 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 index
BMI (kg/m2)
Measured: 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)
Waist Circumference
Measured in cm
Measured: 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)
Conduit artery function
Flow-mediated dilation (percent change from baseline)
Measured: 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)
Resistance vessel function
Reactive hyperemia (blood flow area under the curve)
Measured: 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 function
Blood flow (ml/min)
Measured: 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)
Long-term blood glucose
HbA1c (percent)
Measured: 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)
HDL cholesterol
Concentration (mmol/l)
Measured: 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)
LDL cholesterol
concentration (mmol/l)
Measured: 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)
Triglyceride
concentration (mmol/l)
Measured: 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)
C-reactive protein
mg/l
Measured: 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)
Alanin-aminotransferase
U/L
Measured: 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)
Interleukin 6
Anti and pro-inflammatory cytokine
Measured: 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)
Tumor necrosis factor-alpha
Pro-inflammatory cytokine
Measured: 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)
Interleukin-10
Antoinflammatory cytokine
Measured: 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)
Interleukin-1 receptor antagonist
Anti-inflammatory cytokine
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start11 Jan 2021
- Primary completion25 Nov 2021
- Study completion25 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuriesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized controlled trial
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aalborg University
- Sponsor type
- University, hospital or other
- Collaborators
- Aage og Johanne Louis-Hansens Fond
- Responsible party
- Principal investigator, Rasmus Kopp Hansen, Aalborg University
- Investigators
- Rasmus K Hansen, MSc, Principal investigator, Aalborg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390087
- Sponsor's protocol ID
- N-20190053
- Status last verified
- May 2024
- First submitted
- 6 May 2020
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37534922Hansen 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.
PubMed 35487894Hansen 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.
PubMed 33067301
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04390087
- Acronym / sponsor ID
- N-20190053
- Conditions
- Spinal Cord Injuries, Exercise Training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Aalborg UniversityUniversity, hospital or other
- Collaborators
- Aage og Johanne Louis-Hansens Fond
- Study start
- 11 Jan 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 25 Nov 2021 (actual)
- First posted
- 15 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: ExerciseUpper-body rowing performed up to 30 min, 3 times per week with moderate-to-vigorous intensity |
| Control | No intervention | –The participants allocated to the control group will be asked to maintain their normal lifestyle throughout the intervention period |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ExerciseUpper-body rowing performed while participants are sitting in their own wheelchair. | Other | Exercise |
Primary outcome
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
24 secondary outcomes
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 37534922Hansen 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.
- Derived from this study: PubMed 35487894Hansen 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.
- Derived from this study: PubMed 33067301Hansen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rasmus K Hansen, MSc principal investigator
Aalborg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in people with Spinal Cord Injuries and Exercise Training, run by Aalborg University at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04390087, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.