Spinal Cord InjuriesNCT03284086
VO2peak and Exercise Efficiency in Upper-body Poling
A study testing upper-body double-poling and arm crank ergometry in people with Spinal Cord Injuries, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Spinal Cord Injuries
- What is being tested?
- upper-body double-poling and arm crank ergometry
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2016to May 2017
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- participants between the age of 18 and 50
- well upper-body-trained participants with or without paraplegia
Who cannot join
- people with injuries or sicknesses that might have impacted the testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Peak Oxygen Uptake and Exercise Efficiency Between Upper-body Poling and Arm Crank Ergometry in Trained Paraplegic and Able-bodied Participants
This study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants.
Read the detailed description
Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance performance. In persons who are primarily able to use their upper-body during exercise, such as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested to be of importance for achieving VO2peak and exercise efficiency that are reflective of the aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode. However, it has not yet been investigated whether VO2peak and efficiency differ between ACE and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants. Participants performed four 5-min submaximal stages at increasing effort and an incremental peak test to exhaustion in both ACE and UP.
- Conditions
- Spinal Cord Injuries
- Being tested
- upper-body double-poling, arm crank ergometry
- Keywords
- Oxygen consumption, Physical endurance
- 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.
upper-body double-polingDiagnostic test
An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode.
arm crank ergometryDiagnostic test
An incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode.
| Study group | Role | What they receive |
|---|---|---|
| paraplegic | Other | Well-trained participants with a spinal cord injury (<Th1) were included in this group. Receives: Diagnostic Test: upper-body double-poling; Diagnostic Test: arm crank ergometry |
| able bodied | Other | Upper-body trained, able-bodied participants were included in this group. Receives: Diagnostic Test: upper-body double-poling; Diagnostic Test: arm crank ergometry |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak oxygen uptake
Peak oxygen uptake was measured during an incremental test to exhaustion.
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2017
- Study startSep 2016
- Primary completionMay 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Jorunn Helbostad, phd prof, Study director, Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03284086
- Sponsor's protocol ID
- 2015/2008
- Status last verified
- Sep 2017
- First submitted
- 13 Sep 2017
- Last updated
- 15 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be de-identified by the project coordinator. The de-identified data will be stored on the NTNU server in a folder that only the JKB and ØS have access to. For analysing the data, parts of the de-identified data might be distributed amongst the four researchers and two master students linked to this study.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Peak Oxygen Uptake and Exercise Efficiency Between Upper-body Poling and Arm Crank Ergometry in Trained Paraplegic and Able-bodied Participants
- ClinicalTrials.gov ID
- NCT03284086
- Acronym / sponsor ID
- 2015/2008
- Conditions
- Spinal Cord Injuries
- Keywords
- Oxygen consumption, Physical endurance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Sep 2016 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 15 Sep 2017 (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 study compares peak oxygen uptake (VO2peak) and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants.
Detailed description
Peak oxygen uptake (VO2peak) and exercise efficiency are key factors for endurance performance. In persons who are primarily able to use their upper-body during exercise, such as many Paralympic athletes, the mode most commonly used in assessing VO2peak and efficiency is arm crank ergometry (ACE). However, sport-specificity of the test mode has been suggested to be of importance for achieving VO2peak and exercise efficiency that are reflective of the aerobic capacity in the respective sport. For ice sledge hockey players, cross-country sit skiers and sitting biathletes, upper-body poling (UP) is the most sport-specific test mode. However, it has not yet been investigated whether VO2peak and efficiency differ between ACE and UP. Therefore, the aim of this study was to compare VO2peak and exercise efficiency in upper-body poling versus arm crank ergometry in trained able-bodied and paraplegic participants. Participants performed four 5-min submaximal stages at increasing effort and an incremental peak test to exhaustion in both ACE and UP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| paraplegic | Other | Diagnostic Test: upper-body double-poling, Diagnostic Test: arm crank ergometryWell-trained participants with a spinal cord injury (<Th1) were included in this group. |
| able bodied | Other | Diagnostic Test: upper-body double-poling, Diagnostic Test: arm crank ergometryUpper-body trained, able-bodied participants were included in this group. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- participants between the age of 18 and 50
- well upper-body-trained participants with or without paraplegia
Key exclusion criteria (1 listed)
- people with injuries or sicknesses that might have impacted the testing
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 |
|---|---|---|
| upper-body double-polingAn incremental peak test to exhaustion and four 5-min submaximal stages were performed in the upper-body double-poling mode. | Diagnostic test | able bodied, paraplegic |
| arm crank ergometryAn incremental peak test to exhaustion and four 5-min submaximal stages were performed in the arm crank ergometry mode. | Diagnostic test | able bodied, paraplegic |
Primary outcome
Peak oxygen uptake
Time frame: 3 weeks
Peak oxygen uptake was measured during an incremental test to exhaustion.
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 15 Sep 2017.
- Individual participant dataSharing planned: Yes. All data will be de-identified by the project coordinator. The de-identified data will be stored on the NTNU server in a folder that only the JKB and ØS have access to. For analysing the data, parts of the de-identified data might be distributed amongst the four researchers and two master students linked to this study.
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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.
Jorunn Helbostad, phd prof study director
Dept of Neuromedicine and Movement Science, Norwegian University of Science and Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing upper-body double-poling and arm crank ergometry in people with Spinal Cord Injuries, run by Norwegian University of Science and Technology at 1 site in Norway.
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 2 inclusion and 1 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 15 Sep 2017. 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 Norway. 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?
Peak oxygen uptake (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Sep 2017.