Effectiveness of a 6-week Specific Rehabilitation Program on Walking Capacity in Patients With Lumbar Spinal Stenosis

Effectiveness of a 6-week Specific Rehabilitation Program Combining Education and Exercises on Walking Capacity in Patients With Lumbar Spinal Stenosis With Neurogenic Claudication

The aim of this study is to determine the effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with LSS causing NC.

The intervention group will receive standardized education and specific exercises while the control group will only receive standardized education. The program in both groups will last for 6 weeks with 4 evaluation timepoints (baseline, week 2, week 4 and post-intervention assessment). The primary outcomes will be walking capacity measured with the Self-Paced Walking Test and the secondary outcomes will be back and leg pain intensity, LSS-related disability, self-efficacy, level of physical activity, anxiety and depression, physical activity level, gait pattern characteristics, balance, and global perceived change.

Study Overview

• Status: Completed
• Conditions: Spinal Stenosis
• Intervention / Treatment: Other: Exercises and education; Other: Education alone

• Study Type: Interventional
• Enrollment (Actual): 51
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Trois-Rivières, Quebec, Canada, G8Z 4M3
      • Université du Québec à Trois-Rivières

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• being at least 50 years old
• having a degenerative central LSS alone or in combination with other LSS types (e.g. foraminal, lateral) and/or a spondylolisthesis affecting one or multiple vertebral levels, confirmed by clinical history, physical examination and proper imaging
• having NC associated with LSS
• being able to speak and understand French
• being willing to attend 3 intervention sessions per week
• with a duration of signs and symptoms of at least 3 months
• (7) being able to walk at least 20 meters without walking aid, but not being able to walk continuously for 30 minutes
• being able to provide informed written consent.

Exclusion Criteria:

• congenital LSS,
• symptomatic osteoarthritis (hip or knee) causing limited walking capacity
• neurological disease affecting walking capacity such as Parkinson
• uncontrolled diabetes
• heart failure
• intermittent claudication of vascular origin
• impaired cognitive capacity
• back or lower extremities surgery in the past 3 months

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Group; Intervention group will received education and a specific rehabilitation program (exercises).	Other: Exercises and education; Exercises: 3 training sessions per week that will last for 30 minutes. Sessions will start with 5 minutes of activation (walking on a treadmill or cycling). Then, participants will be asked to complete 5 exercises targeting lower limb strengthening (time: 18 minutes) followed by 2 exercises designed to improve balance and 3 stretching exercises for the lower limb (time: 7 minutes). Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.
Other: Control Group; Control group will received education alone.	Other: Education alone; Education: Two one-on-one sessions (during week 2 and week 4 assessments) during which participants will receive information directly related to LSS and NC using illustration and videos. Participants will also be invited to ask their questions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in walking capacity	Walking capacity measure with the Self-Paced Walking Test (time)	Baseline, week 2, week 4, week 6, week 12

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from baseline in leg and back pain intensity	Leg and back pain intensity will be independently assessed using a 11-point numerical rating scale (from 0 to 10 points). Higher score indicates higher pain.	Baseline, week 2, week 4, week 6, week 12
Change from baseline in lumbar spinal stenosis related disabiltity	Lumbar spinal stenosis related disability is measured with the French-Canadian version of the Swiss Spinal Stenosis Questionnaire. Pain, function and satisfaction related to lumbar spinal stenosis. Pain subscale score range from 7 to 35 with higher values indicate a worst outcome, Function subscale score range from 5 to 20 with higher values indicate a worst outcome, Satisfaction subscale score range from 6 to 24 with higher values indicate a worst outcome. The total score is composed of the three subscales and range from 18 to 79.	Baseline, week 6, week 12
Changes from baseline in self-efficacy	Measured with Self-efficacy measured with the French-Canadian Chronic Pain Self-Efficacy Scale. Each question is rated on a numerical scale (from 1 to 10). Total is calculated using the mean of the 33-items scores and ranges from 1 to 10 with a higher score indicate higher self-efficacy.	Baseline, week 6, week 12
Change from baseline in anxiety and depression	Measured with the French-Canadian adaptation of the Hospital Anxiety and Depression Scale. Total score range from 0 to 21 with higher score indicating symptoms of anxiety and/or depression.	Baseline, week 6, week 12
Change from baseline in physical activity level	Physical activity level assessed with the [Physical Activity Questionnaire for the Elderly]. The questionnaire allows to place participants into one of the 3 categories (low, moderate or high physical activity level). Physical activity level is measured in time per day.	Baseline, week 6, week 12
Patient's global impression of change	Global impression of change will be measured using a 7-point scale that ranges from 'very much improved' to 'very much worse' with 'no change' as the mid-point.	changes of the global impression of change throughout the study (baseline, week 2, week 4, week 6, week 12)
Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors (velocity (m/s))	Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors measured in meters (stride length, swing witdh, toe clearance)	Baseline, week 2, week 4, week 6, week 12
Change from baseline in biomechanical parameters of gait	Spatio-temporal parameters of gait measured with wearable inertial sensors measured in % (walking phases, assymetry, variability)	Baseline, week 2, week 4, week 6, week 12
Change from baseline in lower extremity physical function and balance	Lower extremity physical function and balance measured with the Short Physical Performance Battery. Total score ranges from 0 to 12 with higher score indicating a better lower extremity physical function and balance.	Baseline, week 6, week 12

Collaborators and Investigators

• Sponsor: Université du Québec à Trois-Rivières

Publications and helpful links

General Publications

• Houle M, Tetreau C, Chatillon CE, Marchand AA, Descarreaux M. Effectiveness of a 6-week specific rehabilitation program combining education and exercises on walking capacity in patients with lumbar spinal stenosis with neurogenic claudication: a randomized controlled clinical trial protocol. Trials. 2022 Dec 27;23(1):1046. doi: 10.1186/s13063-022-07011-3.

Study record dates

Study Major Dates

• Study Start (Actual): January 26, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): December 31, 2025

Study Registration Dates

• First Submitted: July 7, 2022
• First Submitted That Met QC Criteria: August 22, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): May 11, 2026
• Last Update Submitted That Met QC Criteria: May 7, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Spinal Stenosis; Walking capacity; Exercises; Education; Neurogenic claudication; gait pattern characteristics
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Behavior; Spinal Stenosis; Motor Activity; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Socioeconomic Factors; Population Characteristics; Exercise; Educational Status
• Other Study ID Numbers: UQTR-2022-program

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No