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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
SSPANLI Trial 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.
SSPANLI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with lumbar spinal stenosis by a spine surgeon.
Select...
I am at least 45 years old.
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My BMI is 25 or higher, indicating I am overweight.
SSPANLI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
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
SSPANLI 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
~68860
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
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with lumbar spinal stenosis by a spine surgeon.I have no health conditions that prevent me from joining a walking program.I am not taking medications that affect my weight or blood sugar levels.I am not scheduled for surgery that would affect my ability to move during the study.I am at least 45 years old.My BMI is 25 or higher, indicating I am overweight.
Research Study Groups:
This trial has the following groups:- Group 1: Lifestyle intervention
- Group 2: Usual Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is there any opportunity to enroll in this research study at present?
"Unfortunately, the clinical trial which was posted on September 1st 2013 and last edited on September 9th is not accepting any more participants. Nonetheless, there are a total of 1213 other medical studies in progress that currently require enrolment."
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