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Lifestyle Intervention for Lumbar Spinal Stenosis (SSPANLI Trial)

N/A
Waitlist Available
Led By Christy Tomkins-Lane
Research Sponsored by Mount Royal University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Subjects will have received a diagnosis of lumbar spinal stenosis (LSS) by a spine surgeon who has both examined the patient and reviewed imaging results (MRI or CT)
Subjects will be at least 45 years of age
Must not have
Subjects on medications known to influence bodyweight or glucoregulation (including antidepressants, sibutramine orlistat, insulin, and metformin) will be excluded
Participants scheduled for any type of surgery that could impact mobility during the intervention period will be removed from the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights

Summary

This trial is testing a new e-health intervention for overweight and obese people with lumbar spinal stenosis. The intervention includes a pedometer and weekly nutrition and physical activity sessions. The investigators hope to see if the intervention leads to greater changes in physical activity, body composition, and quality of life compared to usual care.

Who is the study for?
The SSPANLI trial is for individuals over 45 years old with lumbar spinal stenosis and obesity (BMI of 25 kg/m2 or more), who have been stable in weight for the last three months. It's not suitable for those on certain medications, planning surgery that affects mobility, or with conditions that make walking unsafe.Check my eligibility
What is being tested?
This study tests an online pedometer and nutrition program designed to help overweight people with spinal stenosis lose weight and get more active. Participants are split into two groups: one tries the 12-week e-health intervention, while the other receives usual care without this program.See study design
What are the potential side effects?
Since this is a lifestyle intervention focusing on diet and exercise, side effects may include typical exercise-related discomforts such as muscle soreness or strain. Dietary changes might also cause temporary digestive adjustments.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with lumbar spinal stenosis by a spine surgeon.
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I am at least 45 years old.
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My BMI is 25 or higher, indicating I am overweight.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am not taking medications that affect my weight or blood sugar levels.
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I am not scheduled for surgery that would affect my ability to move during the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change from Baseline in Mean Number of Steps Per Day at 6 months
Change from Baseline in Percent Fat Mass at 6 months
Change from Baseline in Waist Circumference (Centimeters) at 6 months

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Lifestyle interventionExperimental Treatment1 Intervention
In Weeks 1 and 6, people in the intervention group will meet with a Registered Dietitian and an Exercise Physiologist for personalized sessions. They will receive a pedometer and instructions on how to log in to the e-health site (https://sspanli.mtroyal.ca). They will wear the pedometer daily and log in to the website each week for a nutrition education session, a weekly step goal, and tips.
Group II: Usual CareActive Control1 Intervention
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Lifestyle intervention
2011
Completed Phase 4
~68950

Find a Location

Who is running the clinical trial?

Mount Royal UniversityLead Sponsor
2 Previous Clinical Trials
76 Total Patients Enrolled
Christy Tomkins-LanePrincipal InvestigatorMount Royal University

Media Library

Lifestyle intervention Clinical Trial Eligibility Overview. Trial Name: NCT01902979 — N/A
Lumbar Spinal Stenosis Research Study Groups: Lifestyle intervention, Usual Care
Lumbar Spinal Stenosis Clinical Trial 2023: Lifestyle intervention Highlights & Side Effects. Trial Name: NCT01902979 — N/A
Lifestyle intervention 2023 Treatment Timeline for Medical Study. Trial Name: NCT01902979 — N/A
~7 spots leftby Jul 2025