Lumbar Spinal StenosisNCT00958490
Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
A study testing Walking program in people with Lumbar Spinal Stenosis, run by University of Manitoba at 1 site in Canada.
Trial summary
Overall Objective: To evaluate the efficacy of an interventional walking program on the quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery, using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry, step count, weight). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Walking program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects will be between the ages of 18 and 90.
- Male and female subjects will be recruited into the study.
- All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis.
Who cannot join
- Any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program.
- Subjects participating will be required to speak English.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of a Physical Activity Intervention Walking Program on Quality of Life, Physical Activity Monitoring, and Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
Overall Objective: To evaluate the efficacy of an interventional walking program on the quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery, using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry, step count, weight).
Design and Methods: Two groups of subjects will be examined; patients diagnosed with lumbar spinal stenosis (LSS) that progress to surgical management, with one group of subjects staring on the walking program at 2 months postop, and the other group starting on the walking program at 3 months postop.
Read more
Subjects who agree to participate will be assessed (assessments listed below) after the diagnosis preoperatively and 2 months postoperatively. One half of the group will start the walking program at the 2 months postop visit and be assessed again at the end of the walking program, the other half will be assessed again at 3 months postop and start the walking program at that time and be assessed again at 4 months postop. All subjects will be contacted by phone during their walking program to allow for questions from the subjects and to offer support and encouragement. Subjects will be given instructions and a daily diary to track steps taken each day (appendix A).
Subjects will be recruited from the referrals to the practices of the Orthopedic and Neurosurgery Spine Surgeons at the Health Sciences Centre in Winnipeg. This encompasses the majority of new and currently managed cases in the Manitoba and Northwestern Ontario.
Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited into the study. All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis. Exclusion criteria will be any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program. Subjects participating will be required to speak English.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Walking program
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Walking programOther
4 week physical activity walking program
| Study group | Role | What they receive |
|---|---|---|
| First walking group | Active comparator | Group walking at 2 months postop Receives: Other: Walking program |
| Second group walking | Active comparator | Group walking at 3 months postop Receives: Other: Walking program |
What is being measured
The primary outcome is the main question the study is designed to answer.
Physical Activity Monitor
Measured: 1 week x 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionJun 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Investigators
- Michael Johnson, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958490
- Sponsor's protocol ID
- H2006:040
- Status last verified
- Aug 2011
- First submitted
- 12 Aug 2009
- Last updated
- 16 Aug 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Physical Activity Intervention Walking Program on Quality of Life, Physical Activity Monitoring, and Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
- ClinicalTrials.gov ID
- NCT00958490
- Acronym / sponsor ID
- H2006:040
- Conditions
- Lumbar Spinal Stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- Jun 2009
- Primary completion
- Jun 2012 (estimated)
- First posted
- 13 Aug 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.
Overall Objective: To evaluate the efficacy of an interventional walking program on the quality of life and functional status of patients with Lumbar Spinal Stenosis, post-surgery, using subjective (VAS, ODI, RMDQ, SF-36), and objective measures (triaxial accelerometry, step count, weight).
Design and Methods: Two groups of subjects will be examined; patients diagnosed with lumbar spinal stenosis (LSS) that progress to surgical management, with one group of subjects staring on the walking program at 2 months postop, and the other group starting on the walking program at 3 months postop.
Subjects who agree to participate will be assessed (assessments listed below) after the diagnosis preoperatively and 2 months postoperatively. One half of the group will start the walking program at the 2 months postop visit and be assessed again at the end of the walking program, the other half will be assessed again at 3 months postop and start the walking program at that time and be assessed again at 4 months postop. All subjects will be contacted by phone during their walking program to allow for questions from the subjects and to offer support and encouragement. Subjects will be given instructions and a daily diary to track steps taken each day (appendix A).
Subjects will be recruited from the referrals to the practices of the Orthopedic and Neurosurgery Spine Surgeons at the Health Sciences Centre in Winnipeg. This encompasses the majority of new and currently managed cases in the Manitoba and Northwestern Ontario.
Subjects will be between the ages of 18 and 90. Male and female subjects will be recruited into the study. All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis. Exclusion criteria will be any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program. Subjects participating will be required to speak English.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| First walking group | Active comparator | Other: Walking programGroup walking at 2 months postop |
| Second group walking | Active comparator | Other: Walking programGroup walking at 3 months postop |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects will be between the ages of 18 and 90.
- Male and female subjects will be recruited into the study.
- All LSS patients will demonstrate intractable neurogenic claudication and radiographically confirmed lumbar spinal stenosis.
Key exclusion criteria (2 listed)
- Any previous lumbar spine surgery, the existence of significant co-morbidity (e.g. neurologic or cardiac condition, disease, etc.) of any form, and any other physical limitations (musculoskeletal injury) preventing the subject from participating in regular activity and the walking program.
- Subjects participating will be required to speak English.
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 |
|---|---|---|
| Walking program4 week physical activity walking program | Other | First walking group, Second group walking |
Primary outcome
Physical Activity Monitor
Time frame: 1 week x 4
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2011.
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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.
Michael Johnson, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Walking program in people with Lumbar Spinal Stenosis, run by University of Manitoba at 1 site in Canada.
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 3 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: status not confirmed, as of the sponsor's last update on 16 Aug 2011. 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 Canada. 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?
Results are not available in the source record.
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?
Physical Activity Monitor (time frame: 1 week x 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 16 Aug 2011.