Spinal Cord InjuryNCT01184729
6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity
An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.
Trial summary
The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury
- How many people
- 27 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2008to Sep 2013
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Community sample of persons with spinal cord injury
Who may be able to join
- T1 or lower injury
- at least 1 year post-injury
- able to self-propel a manual wheelchair
- enrolled in TMP-MN-006
Who cannot join
- Not enrolled in the IRB approval parent study, "Exercise Treatment of Obesity-Related Secondary Conditions in Adults with Paraplegia", TMP-MN-006
- Unstable angina or myocardial infarction within the past month
- Resting heart rate >120
- Systolic blood pressure > 180 mm Hg
- Diastolic blood pressure > 100 mm Hg
Trial locations and contacts
1 site in 1 country.
United States1 site
The Miami Project to Cure Paralysis
Miami, Florida, 33136
About this study
The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features.
Read the detailed description
The 6 minute walk test is a widely used assessment of aerobic capacity, function, and functional change in the ambulatory population. A similar clinical and research outcome instrument that is responsive to changes in aerobic capacity and function are lacking for persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk test may fill the void. The primary aim of this project is to assess if distance traveled in 6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We hypothesize that participants will push farther in 6 minutes after their aerobic capacity increases. The secondary aim is to explore the correlation between 6MPT distance and handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental features. We hypothesize increasing 6MPTdistance will be correlated with decreasing depression, decreasing handicap, decreasing self-reported avoidance of environmental features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.
- Conditions
- Spinal Cord Injury
- Keywords
- aerobic capacity
- 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.
| Study group | Role | What they receive |
|---|---|---|
| Spinal Cord Injury | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Oxygen uptake during 6 min Push Test From baseline.
Subjects will be prepared by putting a flexible mask over the mouth and nose. Heart rate during testing will be monitored by either three electrodes on the chest or by a monitor strapped around the chest. Heart rate and oxygen consumption during each 6MPT will be measured. Participants will be instructed to propel as far as possible on a 30m loop marked at 3m intervals, with 15m between pylons, and two 180 degree turns. Distance traveled in 6 minutes (m) will be computed by multiplying the number of full laps completed by 15m and adding the distance traveled in the last lap.
Measured: Visits 1-4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startNov 2008
- Primary completionSep 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord InjuryStudies of the same condition, open and under way.
- More trials run by University of MiamiThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Miami
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mark S. Nash, Ph.D., FACSM, University of Miami
- Investigators
- Mark S Nash, PhD, Principal investigator, University of Miami, The Miami Project to Cure Paralysis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184729
- Sponsor's protocol ID
- TMP MN 002
- Status last verified
- Jul 2014
- First submitted
- 18 Aug 2010
- Last updated
- 22 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 6 Minute Propulsion Test Sensitivity to Increased Aerobic Capacity
- ClinicalTrials.gov ID
- NCT01184729
- Acronym / sponsor ID
- TMP MN 002
- Conditions
- Spinal Cord Injury
- Keywords
- aerobic capacity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- University of MiamiUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Sep 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 19 Aug 2010 (estimated)
- 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.
The goals of this project are to 1)determine the responsiveness of the 6 Minute Push Test (6MPT) and 2) explore the relationship between 6MPT distance and measures of handicap, wheelchair satisfaction, depression, and self-reported avoidance of environmental features.
Detailed description
The 6 minute walk test is a widely used assessment of aerobic capacity, function, and functional change in the ambulatory population. A similar clinical and research outcome instrument that is responsive to changes in aerobic capacity and function are lacking for persons with spinal cord injury (SCI). A 6 minute push test, adapted from the 6 minute walk test may fill the void. The primary aim of this project is to assess if distance traveled in 6 minutes of wheelchair propulsion changes after an increase in aerobic capacity. We hypothesize that participants will push farther in 6 minutes after their aerobic capacity increases. The secondary aim is to explore the correlation between 6MPT distance and handicap, depression, wheelchair satisfaction, and self-reported avoidance of environmental features. We hypothesize increasing 6MPTdistance will be correlated with decreasing depression, decreasing handicap, decreasing self-reported avoidance of environmental features, and increasing wheelchair satisfaction. This is a low risk, high benefit study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Spinal Cord Injury | – | – |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Community sample of persons with spinal cord injury
Key inclusion criteria (4 listed)
- T1 or lower injury
- at least 1 year post-injury
- able to self-propel a manual wheelchair
- enrolled in TMP-MN-006
Key exclusion criteria (5 listed)
- Not enrolled in the IRB approval parent study, "Exercise Treatment of Obesity-Related Secondary Conditions in Adults with Paraplegia", TMP-MN-006
- Unstable angina or myocardial infarction within the past month
- Resting heart rate >120
- Systolic blood pressure > 180 mm Hg
- Diastolic blood pressure > 100 mm Hg
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in Oxygen uptake during 6 min Push Test From baseline.
Time frame: Visits 1-4
Subjects will be prepared by putting a flexible mask over the mouth and nose. Heart rate during testing will be monitored by either three electrodes on the chest or by a monitor strapped around the chest. Heart rate and oxygen consumption during each 6MPT will be measured. Participants will be instructed to propel as far as possible on a 30m loop marked at 3m intervals, with 15m between pylons, and two 180 degree turns. Distance traveled in 6 minutes (m) will be computed by multiplying the number of full laps completed by 15m and adding the distance traveled in the last lap.
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 22 Jul 2014.
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SERENITY Study of Chronic Pain Interference in Adults
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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.
Mark S Nash, PhD principal investigator
University of Miami, The Miami Project to Cure Paralysis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Spinal Cord Injury, run by University of Miami at 1 site in United States.
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 22 Jul 2014. 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 United States. 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?
Change in Oxygen uptake during 6 min Push Test From baseline. (time frame: Visits 1-4). 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 22 Jul 2014.