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

NCT00958490 | Unknown

• 1 other identifier: H2006:040
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Lumbar Spinal Stenosis

Outcome Measures

Primary Outcomes (1)

• Physical Activity Monitor

  1 week x 4

Study Arms (2)

First walking group

ACTIVE COMPARATOR

Group walking at 2 months postop

Other: Walking program

Second group walking

ACTIVE COMPARATOR

Group walking at 3 months postop

Other: Walking program

Interventions

Walking program OTHER

4 week physical activity walking program

First walking group; Second group walking

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A 1R9, Canada

Location

MeSH Terms

Conditions

Spinal Stenosis

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Officials

• Michael Johnson, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: August 12, 2009
• First Posted: August 13, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Last Updated: August 16, 2011

Record last verified: 2011-08

Locations

CA (1)