Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
Primary Purpose
Lumbar Spinal Stenosis
Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Walking program
Sponsored by
About this trial
This is an interventional treatment trial for Lumbar Spinal Stenosis
Eligibility Criteria
Inclusion Criteria:
- 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:
- 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.
Sites / Locations
- Health Sciences Centre
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
First walking group
Second group walking
Arm Description
Group walking at 2 months postop
Group walking at 3 months postop
Outcomes
Primary Outcome Measures
Physical Activity Monitor
Secondary Outcome Measures
Full Information
NCT ID
NCT00958490
First Posted
August 12, 2009
Last Updated
August 13, 2011
Sponsor
University of Manitoba
1. Study Identification
Unique Protocol Identification Number
NCT00958490
Brief Title
Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
June 2009 (undefined)
Primary Completion Date
June 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Manitoba
4. Oversight
5. Study Description
Brief 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lumbar Spinal Stenosis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
First walking group
Arm Type
Active Comparator
Arm Description
Group walking at 2 months postop
Arm Title
Second group walking
Arm Type
Active Comparator
Arm Description
Group walking at 3 months postop
Intervention Type
Other
Intervention Name(s)
Walking program
Intervention Description
4 week physical activity walking program
Primary Outcome Measure Information:
Title
Physical Activity Monitor
Time Frame
1 week x 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Johnson, MD
Organizational Affiliation
University of Manitoba
Official's Role
Principal Investigator
Facility Information:
Facility Name
Health Sciences Centre
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
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