Spinal Cord InjuryNCT00866112
A Randomized Exercise Trial for Wheelchair Users
A study testing Educational session to promote physical activity and Minimal contact in people with Spinal Cord Injury and Multiple Sclerosis, run by University of Kansas at 1 site in United States.
Trial summary
People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury, Multiple Sclerosis, Muscular Dystrophy
- What is being tested?
- Educational session to promote physical activity and Minimal contact
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 1 siteUnited States
- Study dates
- May 2008to Jun 2012
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home
- Have not been moderately to vigorously physically active for the past 6 months
- Be willing to attend the educational workshop
- Receive physician approval for participation
Who cannot join
- Presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise
- Pregnancy or planning to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.
- Conditions
- Spinal Cord Injury, Multiple Sclerosis, Muscular Dystrophy, Cerebral Palsy, Spina Bifida, Amputation
- Being tested
- Educational session to promote physical activity, Minimal contact
- Keywords
- Wheelchair use, Spinal cord injury, Multiple sclerosis, Muscular dystrophy, Cerebral palsy, Spina bifida, Amputation, Arthritis, Stroke
- Medical subject headings
- Spinal Cord Injuries, Multiple Sclerosis, Muscular Dystrophies, Cerebral Palsy, Spinal Dysraphism, Arthritis, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational session to promote physical activityOther
Educational session, goal setting, self monitoring of daily engagement in physical activity
Minimal contactOther
Self guided education manual about adopting physical activity, self monitor daily engagement in physical activity
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Intervention group to promote physical activity Receives: Other: Educational session to promote physical activity |
| 2 | Other | Minimal contact control group Receives: Other: Minimal contact |
What is being measured
The primary outcome is the main question the study is designed to answer.
Weekly minutes spent in aerobic and strengthening activity
Measured: Baseline, 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2009 (estimated)
- Study startMay 2008
- Primary completionFeb 2011
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Spinal Cord InjuryStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 135 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Kansas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kathleen Grobe, University of Kansas
- Investigators
- Katherine Froehlich-Grobe, PhD, Principal investigator, University of Kansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00866112
- Sponsor's protocol ID
- 10053
- Status last verified
- Apr 2010
- First submitted
- 19 Mar 2009
- Last updated
- 15 Jun 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Froehlich-Grobe K, Nary DE, VanSciver A, Washburn RA, Aaronson L. Truth be told: evidence of wheelchair users' accuracy in reporting their height and weight. Arch Phys Med Rehabil. 2012 Nov;93(11):2055-61. doi: 10.1016/j.apmr.2012.05.005. Epub 2012 May 15.
PubMed 22609118Nary DE, Froehlich-Grobe K, Aaronson L. Recruitment issues in a randomized controlled exercise trial targeting wheelchair users. Contemp Clin Trials. 2011 Mar;32(2):188-95. doi: 10.1016/j.cct.2010.10.010. Epub 2010 Oct 27.
PubMed 21035565
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Exercise Trial for Wheelchair Users
- ClinicalTrials.gov ID
- NCT00866112
- Acronym / sponsor ID
- 10053
- Conditions
- Spinal Cord Injury, Multiple Sclerosis, Muscular Dystrophy, Cerebral Palsy, Spina Bifida, Amputation
- Keywords
- Wheelchair use, Spinal cord injury, Multiple sclerosis, Muscular dystrophy, Cerebral palsy, Spina bifida, Amputation, Arthritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 135 participants (actual)
- Lead sponsor
- University of KansasUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 20 Mar 2009 (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.
People with mobility disabilities are at greater risk than the general population for incurring health problems. Many of these conditions are preventable through behavior and lifestyle changes such as exercise and physical activity. Recent evidence suggests that people with disabilities experience the same physiologic response to exercise as the general population. Nonetheless, nearly three-fourths of those with disabilities report being entirely sedentary or not active enough to achieve health benefits. Despite some knowledge of issues that limit physical activity among this population, few studies have investigated methods for promoting physical activity adoption among people with disabilities, including wheelchair users. The purpose of this study is to test the effectiveness of a behavioral intervention to promote physical activity adoption over 6 months and maintenance of physical activity over another 6 months by community-dwelling manual wheelchair users.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Educational session to promote physical activityIntervention group to promote physical activity |
| 2 | Other | Other: Minimal contactMinimal contact control group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Be experiencing a permanent disability of at least 6 months that limits mobility sufficiently to require use of a wheelchair as the primary method of mobility outside the home
- Have not been moderately to vigorously physically active for the past 6 months
- Be willing to attend the educational workshop
- Receive physician approval for participation
Key exclusion criteria (2 listed)
- Presence of medical conditions such as uncontrolled cardiovascular problems that the patient's physician identifies as being contraindicated for exercise
- Pregnancy or planning to become pregnant
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 |
|---|---|---|
| Educational session to promote physical activityEducational session, goal setting, self monitoring of daily engagement in physical activity | Other | 1 |
| Minimal contactSelf guided education manual about adopting physical activity, self monitor daily engagement in physical activity | Other | 2 |
Primary outcome
Weekly minutes spent in aerobic and strengthening activity
Time frame: Baseline, 12, 26 and 52 weeks
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 Jun 2012.
- Derived from this study: PubMed 22609118Froehlich-Grobe K, Nary DE, VanSciver A, Washburn RA, Aaronson L. Truth be told: evidence of wheelchair users' accuracy in reporting their height and weight. Arch Phys Med Rehabil. 2012 Nov;93(11):2055-61. doi: 10.1016/j.apmr.2012.05.005. Epub 2012 May 15.
- Derived from this study: PubMed 21035565Nary DE, Froehlich-Grobe K, Aaronson L. Recruitment issues in a randomized controlled exercise trial targeting wheelchair users. Contemp Clin Trials. 2011 Mar;32(2):188-95. doi: 10.1016/j.cct.2010.10.010. Epub 2010 Oct 27.
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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.
Katherine Froehlich-Grobe, PhD principal investigator
University of Kansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Educational session to promote physical activity and Minimal contact in people with Spinal Cord Injury and Multiple Sclerosis, run by University of Kansas 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 2 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 Jun 2012. 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?
Weekly minutes spent in aerobic and strengthening activity (time frame: Baseline, 12, 26 and 52 weeks). 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 NCT00866112, which also lists 2 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 15 Jun 2012.