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.

Study Overview

• Status: Unknown
• Conditions: Lumbar Spinal Stenosis
• Intervention / Treatment: Other: Walking program

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3A 1R9
      • Health Sciences Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 90 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: First walking group; Group walking at 2 months postop	Other: Walking program; 4 week physical activity walking program
Active Comparator: Second group walking; Group walking at 3 months postop	Other: Walking program; 4 week physical activity walking program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical Activity Monitor	1 week x 4

Collaborators and Investigators

• Sponsor: University of Manitoba
• Investigators: Principal Investigator: Michael Johnson, MD, University of Manitoba

Study record dates

Study Major Dates

• Study Start: June 1, 2009
• Primary Completion (Anticipated): June 1, 2012

Study Registration Dates

• First Submitted: August 12, 2009
• First Submitted That Met QC Criteria: August 12, 2009
• First Posted (Estimate): August 13, 2009

Study Record Updates

• Last Update Posted (Estimate): August 16, 2011
• Last Update Submitted That Met QC Criteria: August 13, 2011
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Constriction, Pathologic; Spinal Stenosis
• Other Study ID Numbers: H2006:040