Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients

This study is enrolling participants by invitation only.
Sponsor:
Information provided by:
University of Manitoba
ClinicalTrials.gov Identifier:
NCT00958490
First received: August 12, 2009
Last updated: August 13, 2011
Last verified: August 2011

August 12, 2009
August 13, 2011
June 2009
June 2012   (final data collection date for primary outcome measure)
Physical Activity Monitor [ Time Frame: 1 week x 4 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00958490 on ClinicalTrials.gov Archive Site
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Effects of a Walking Program on Functional Status of Post-Surgical Lumbar Spinal Stenosis Patients
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.

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.

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Interventional
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Lumbar Spinal Stenosis
Other: Walking program
4 week physical activity walking program
  • Active Comparator: First walking group
    Group walking at 2 months postop
    Intervention: Other: Walking program
  • Active Comparator: Second group walking
    Group walking at 3 months postop
    Intervention: Other: Walking program
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
50
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June 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 90 Years
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00958490
H2006:040
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Dr. Michael Johnson/Principal Investigator, University of Manitoba
University of Manitoba
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Principal Investigator: Michael Johnson, MD University of Manitoba
University of Manitoba
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP